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[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer (/clinicaltrials/prostate-cancer/94511-18f-fluoro-2-deoxy-d-glucose-and-18f-dihydrotestosterone-pet-imaging-in-patients-with-progressive-prostate-cancer.html) {{header-clinical-trials-navigation}}

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer Condition: Prostate Cancer Intervention: Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Purpose: This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT00588185 Sponsor: Memorial Sloan Kettering Cancer Center Primary Outcome Measures: Measure: To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.

Time Frame: Baseline, 4 weeks and 12 weeks

Safety Issue: Secondary Outcome Measures: Measure: The kinetics, metabolism, and biodistribution will be assessed.

Time Frame: Baseline. 4 weeks and 12 weeks

Safety Issue:

Measure: To correlate the accumulation of 18FDHT to 18FDG.

Time Frame: 2 years

Safety Issue:

Measure: To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor

Time Frame: 2 years

Safety Issue:

Measure: relationship between FDHT uptake and tumor diffusivity

Time Frame: 2 years

Safety Issue:

Measure: relationship between FDHT uptake and tissue analyses

Time Frame: 2 years

Safety Issue: Estimated Enrollment: 300 Study Start Date: February 2003 Eligibility: Age: minimum N/A maximum N/A

Gender: Male Inclusion Criteria: Patients with histologically confirmed prostate cancer.

Progressive disease manifest by either:

Imaging modalities:

Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or

Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.

Visible lesions by either CT, bone imaging, or MRI consistent with disease.

Informed consent. Exclusion Criteria: Previous anaphylactic reaction to either FDHT or FDG

Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin < 2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN

Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min Contact: Michael Morris, M.D., PH.D.

646-422-4469 Location: Memorial Sloan Kettering Cancer Center

New York New York 10065 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00588185)

{{footer-clinical-trials-navigation}} Published March 5, 2017

3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate (/clinical-trials/prostate-cancer/94516-3t-perfluorocarbonfilled-endorectal-magnetic-resonance-spectroscopic-imaging-ofprostate.html) {{header-clinical-trials-navigation}}

3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate Condition: Prostate Cancer Intervention: Procedure: 3T Magnetic Resonance Spectroscopic Imaging Purpose: Objectives: The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in improving the spectral resolution, using a PFC-filled endorectal coil, 2) develop a systematic metabolic grading system for tumor detection by identifying the abnormal peak areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled endorectal 3T MRSI, and 3) evaluate the efficacy of the metabolic grading system in tumor detection. The long-term goal of the study is to provide an early prognostic indicator and means of monitoring the biologic status of the prostate cancer during the course of the disease. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT00464724 Sponsor: M.D. Anderson Cancer Center Primary Outcome Measures: Measure: Comparison of linewidths collected from AIR MRSI and PFC-MSRI

Time Frame: 2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams

Safety Issue: Estimated Enrollment: 80 Study Start Date: March 2007 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: 1. Biopsy proven, clinical stage 1-3 prostate carcinomas

2. Prostatectomy at M. D. Anderson within 3 months from the time of MRSI

3. An interval of > 6 weeks between the biopsy and MRSI

4. Signed informed consent form Exclusion Criteria: 1. Contraindications for MRI (e.g. cardiac pacemaker)

2. Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)

3. Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field

4. Previous prostate surgery for prostate carcinoma (including, TURP and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, BCG for bladder cancer Contact: Haesun Choi, MD

713-745-4693 Location: University of Texas MD Anderson Cancer Center

Houston Texas 77030 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00464724)

{{footer-clinical-trials-navigation}} Published March 5, 2017

A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients (/clinical-trials/prostate-cancer/94508-a-comprehensivemultimodality-quality-of-life-study-for-prostate-cancer-patients.html) {{header-clinical-trials-navigation}}

A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients Condition: Prostate Cancer Intervention: Behavioral: Questionnaire Purpose: The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer. Study Type: Observational Clinical Trials Identifier NCT 8-digits: NCT00561444 Sponsor: M.D. Anderson Cancer Center Primary Outcome Measures: Measure: QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey

Time Frame: Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more years.

Safety Issue: Estimated Enrollment: 1448 Study Start Date: November 2007 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: 1. Primary treatment at MD Anderson for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy, photon external beam radiation, photon external beam radiation with hormone therapy, proton radiation, radioisotopic implant, cryotherapy, or active surveillance.

2. Neoadjuvant, concurrent and adjuvant androgen ablation in conjunction with photon external beam radiation is allowed if not greater than 6 months total duration. Hormone therapy will be given as an LHRH agonist with or without an antiandrogen.

3. Pathologic diagnosis of prostate adenocarcinoma

4. AJCC (VI) stage T1-T3b N0M0

5. Ability to read, write, and fill out the self-survey questionnaires

6. Patients may be simultaneously enrolled on other MD Anderson treatment or laboratory protocols. The EPIC Survey will be used for both this protocol and for protocol 2007-0209 such that patients enrolled on both protocols will complete only one document at each survey point. Simultaneous enrollment on other survey protocols will be handled in a similar manner. Exclusion Criteria: 1. Histology other than adenocarcinoma

2. Stage T4, nodal or distant metastasis

3. Prior treatment for prostate cancer except for neoadjuvant, concurrent and adjuvant androgen deprivation of 6 months or less duration in patients treated with photon radiation. Hormone therapy in all other modalities is not allowed.

4. Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment

5. Treatment for another pelvic malignancy, to include surgery or radiation

6. Treatment for another malignancy with chemotherapy completed within one year or less of treatment for prostate cancer.

7. Inflammatory bowel disease (eg. Crohn's or Ulcerative Colitis)

8. Patients 18 years or younger. Contact: Deborah A. Kuban, MD

713-563-7382 Locations: MD Anderson at Cooper

Voorhees Township New Jersey 08043 United States

MD Anderson Cancer Center at Albuquerque

Albuquerque New Mexico 87110 United States

University of Texas MD Anderson Cancer Center

Houston Texas 77030 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00561444)

{{footer-clinical-trials-navigation}} Published March 5, 2017

A Feasibility Study of Oral Hormonal Therapy and Radiation for Nonmetastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities (/clinical-trials/prostate-cancer/96901-afeasibility-study-of-oral-hormonal-therapy-and-radiation-for-non-metastaticintermediate-or-high-risk-prostate-cancer-in-men-70-and-older-or-withmedical-comorbidities.html) {{header-clinical-trials-navigation}}

A Feasibility Study of Oral Hormonal Therapy and Radiation for Nonmetastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities Condition: Prostate Cancer Intervention: Drug: Bicalutamide

Drug: Dutasteride

Drug: Finasteride

Radiation: Radiation Purpose: The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01342367 Sponsor: University of Chicago Primary Outcome Measures: Measure: Quality of Life

Time Frame: 6 months

Safety Issue: Secondary Outcome Measures: Measure: Progression Free Survival

Time Frame: 5 years

Safety Issue: Estimated Enrollment: 40 Study Start Date: December 17, 2010 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Age > or = 70 years and/or Charlson comorbidity index score > or = 2

Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma

Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%

One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3aT4

Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection

No evidence of bone metastases on bone scan

History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration

Zubrod Performance Status 0-2

Age > or = 18

Baseline serum PSA within 60 days prior to registration

Baseline serum testosterone obtained within 60 days prior to registration

Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride

CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function

Patient must be able to provide study-specific informed consent prior to study entry

Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal Exclusion Criteria: Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer

Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy

Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer

Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted

Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields

Active lupus or scleroderma

Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of normal,clinical jaundice, and/or coagulation defects

Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation Location: University of Chicago

Chicago Illinois 60637 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01342367)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System (/clinical-trials/prostate-cancer/96941-a-feasibility-study-toevaluate-the-safety-and-initial-effectiveness-of-exablate-mr-guided-focusedultrasound-surgery-in-the-treatment-of-pain-resulting-from-metastatic-bonetumors-with-the-exablate-2100-conformal-bone-system.html) {{header-clinical-trials-navigation}}

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System Condition: Bone Metastases Intervention: Device: ExAblate 2100 Purpose: A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT00981578 Sponsor: InSightec Primary Outcome Measures: Measure: Adverse device effects

Time Frame: 3 months

Safety Issue: Secondary Outcome Measures: Measure: Pain scores

Time Frame: 3 months

Safety Issue:

Measure: Quality of life

Time Frame: 3 months

Safety Issue:

Measure: Changes in pain medications

Time Frame: 3 months

Safety Issue: Estimated Enrollment: 50 Study Start Date: September 2009 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: All Inclusion Criteria: 1. Men and women age 18 and older 2. Patients who are able and willing to give consent and able to attend all study visits 3. Patients who are suffering from symptoms of bone metastases 4. One to 3 painful lesions. 5. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3

L5), Sacral vertebra (S1

S5) 6. Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated: o If patient has pain from additional sites that are not planned for treatment, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site(s) to be treated. 7. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication 8. Targeted tumors (most painful) size up to 8 cm in diameter 9. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin. 10. Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible 11. Able to communicate sensations during the ExAblate MRgFUS treatment 12. At least 2 weeks since chemotherapy 13. No radiation therapy to targeted (most painful) tumors in the past two weeks Exclusion Criteria: 1. Patients who either

Need surgical stabilization of the affected weight bearing bony structure (>7 fracture risk score, see Section 6.9) OR

Targeted tumor is at an impending fracture site of the weigh bearing bone (>7 on fracture risk score, see Section 6.9). OR o Patients with surgical stabilization of tumor site with metallic hardware 2. More than 3 painful lesions or more than 2 requiring immediate localized treatment 3. The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS. 4. Targeted tumor is in the skull 5. Patients on dialysis 6. Patients with life expectancy < 6-Months 7. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study. 8. Patients with unstable cardiac status including:

Unstable angina pectoris on medication

Patients with documented myocardial infarction within six months of protocol entry

Congestive heart failure requiring medication (other than diuretic)

Patients on anti-arrhythmic drugs 9. Severe hypertension (diastolic BP > 100 on medication) 10. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 11. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. 12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 13. KPS Score < 60 (See "Definitions" below) 14. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 15. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time.) 16. Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels or bladder. 17. Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days 18. Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks 19. Patients unable to communicate with the investigator and staff. 20. Patients with persistent undistinguishable pain (pain source unidentifiable) 21. Targeted (most painful) tumors size > 8 cm in diameter 22. Targeted (most painful) tumors:

NOT visible by non-contrast MRI, OR

NOT accessible to ExAblate device Locations: City of Hope

Duarte California 91010 United States

University of California San Francisco

San Francisco California 94107 United States

Stanford University Medical Center

Stanford California 94305 United States

Methodist Hospital Research Institute

Houston Texas 77030 United States

University of Virginia

Charlottesville Virginia 22908 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00981578)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity (/clinicaltrials/prostate-cancer/96898-a-first-in-man-phase-i-evaluation-of-a-singlecycle-of-prohibitin-targeting-peptide-1-in-patients-with-metastatic-prostatecancer-and-obesity.html) {{header-clinical-trials-navigation}}

A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity Condition: Prostate Cancer Intervention: Drug: Prohibitin-TP01 Purpose: The goal of this clinical research study is to find the highest tolerable dose of PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there are no standard therapy options. The safety of this drug will also be studied. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01262664 Sponsor: M.D. Anderson Cancer Center Primary Outcome Measures: Measure: Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity

Time Frame: 58 days

Safety Issue:

Measure: Biologic Activity of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity

Time Frame: 28 days

Safety Issue: Estimated Enrollment: 4 Study Start Date: May 24, 2012 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: 1. Have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a BMI defined as obese (i.e. >30 kg/m2). Any histologic variant is acceptable other than small cell carcinoma.

2. Have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.

3. Patients with castrate resistant prostate cancer (CRPC) must have no standard options for therapy. Prior to registration on the study, patients with CRPC must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).

4. Have an ECOG performance status 0, 1 or 2

5. Have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dL (without transfusion or growth factor support)

6. Have adequate hepatic function defined as a total bilirubin of

7. Have adequate renal function defined as serum creatinine/= 60 mL/min (measured or calculated). In addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. EXCEPTION: Patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.

8. Have adequate cardiovascular function as defined by: i) a normal B-type Natruetic Peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ECG. If these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (MUGA) showing an EF of 45% or greater with no more than "mild" diastolic dysfunction and a BNP of < 200 pg/mL to be eligible.

9. Sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution Exclusion Criteria: 1. Small cell prostate cancer

2. Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy

3. Any of the following in previous 6 months: NYHA Class III/IV congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ECG or serologic criteria)

4. Significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this may be better established with home BP readings than with clinic visit results. Note further that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. The intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, NOT to exclude patients who may be hypertensive acutely. There are no absolute criteria for BP readings with respect to eligibility (as determined by treating physician).

5. ( # 9 cont'd) (ii) Uncontrolled diabetes mellitus, defined as: Hgb A1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) Lung disease requiring supplemental oxygen iv) Known chronic liver disease causing either fibrosis or synthetic dysfunction v) Known HIV infection vi) Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.

6. Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. EXCEPTION: Non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.

7. Patients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).

8. Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.

9. Unwillingness to maintain adequate contraception measures for the entire course of the study

10. Age < 18 years. Location: University of Texas MD Anderson Cancer Center

Houston Texas 77030 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01262664)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve P (/clinical-trials/prostatecancer/99268-a-multi-centre-prospective-observational-study-oneffectiveness-and-safety-of-zoladex-goserelin-acetate-implant-10-8-mg-andzoladex-goserelin-acetate-implant-3-6-mg-in-chinese-patients-with-localizedor-locally-advanced-hormonal-treatment-naive-p.html) {{header-clinical-trials-navigation}}

A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer Condition: Localized or Locally Advanced Prostate Cancer Purpose: This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical sites in China. The effectiveness and safety data will be collected at baseline and each visit within 26 weeks after treatment of Zoladex®. Study Type: Observational Clinical Trials Identifier NCT 8-digits: NCT03193060 Sponsor: AstraZeneca Primary Outcome Measures: Measure: PSA level

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Serum Testosterone

Time Frame: each visit within 26 weeks during treatment

Safety Issue: Secondary Outcome Measures: Measure: Mean serum Testosterone level

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Mean serum PSA level

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Number of patients with serum Testosterone less than 50 ng/ml

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Incidence of Adverse Events (AEs)

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Incidence of AESI (cardiovascular related AE, sexual related AE)

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Incidence of Adverse Drug Reactions (ADRs)

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Incidence of AEs leading to treatment discontinuation

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Proportion of patients with serum Testosterone less than 50 ng/ml

Time Frame: each visit within 26 weeks during treatment

Safety Issue:

Measure: Incidence of Serious Adverse Events (SAEs)

Time Frame: each visit within 26 weeks during treatment

Safety Issue: Estimated Enrollment: 500 Study Start Date: September 19, 2017 Eligibility: Age: minimum 18 Years maximum 100 Years

Gender: Male Inclusion Criteria: 1. Ability to provide informed consent, complete all study assessments and have complete medical record;

2. Male aged 18 years and over;

3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;

4. Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);

5. More than 26 weeks' life expectancy; Exclusion Criteria: 1. Patients who are planned to receive radiation therapy;

2. Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;

3. Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists. Contact: AstraZeneca Clinical Study Information Center

[email protected]

1-877-240-9479 Locations: Research Site

Huizhou Guangdong China

Research Site

Zhuhai Guangdong China

Research Site

Shi Jiazhuang He Bei China

Research Site

Langfang Hebei China

Research Site

Baotou Inner Mongolia China

Research Site

Nanjing Jiangsu China

Research Site

Yinchuan Ningxia China

Research Site

Jinan Shandong China

Research Site

Yantai Shandong China

Research Site

Ningbo Zhejiang China View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03193060)

{{footer-clinical-trials-navigation}} Published October 16, 2017

A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia (/clinical-trials/prostate-cancer/93319-a-multicenterprospective-longitudinal-registry-of-patients-with-prostate-cancer-inasia.html) {{header-clinical-trials-navigation}}

A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia Condition: Prostatic Neoplasms Intervention: Other: No Intervention Purpose: The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice. Study Type: Observational [Patient Registry] Clinical Trials Identifier NCT 8-digits: NCT02546908 Sponsor: Janssen Research & Development, LLC Primary Outcome Measures: Measure: Overall Survival (OS)

Time Frame: up to 5 years

Safety Issue:

Measure: Prostate Cancer (PC)-related Mortality (PM)

Time Frame: up to 5 years

Safety Issue:

Measure: Metastasis-free survival (MFS)

Time Frame: up to 5 years

Safety Issue:

Measure: Progression-free Survival (PFS)

Time Frame: up to 5 years

Safety Issue:

Measure: Time to Prostate-specific Antigen (PSA) Progression (TTPP)

Time Frame: up to 5 years

Safety Issue:

Measure: European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score

Time Frame: up to 5 years

Safety Issue:

Measure: Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score

Time Frame: up to 5 years

Safety Issue: Estimated Enrollment: 3830 Study Start Date: September 9, 2015 Eligibility: Age: minimum 21 Years maximum N/A

Gender: Male Inclusion Criteria: Male aged 21 years or older

Documented diagnosis of PC with either: High-risk localized PC; Non-metastatic, biochemically recurrent PC; Metastatic PC

Signed participation agreement/Informed Consent Form (ICF) by the patient or a legally acceptable representative

Agree to be followed-up for PC per routine clinical care Exclusion Criteria:

No specific Exclusion Criteria: No specific exclusion criteria's were defined Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

[email protected] Locations: Beijng University 1st Hospital

Beijing 100034 China

Beijing Hospital

Beijing 100730 China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing China

the 3rd Affiliated Hospital,Sun Yansen University

Guangzhou 510630 China

1st Affliated Hospital of Zhejiang University Medical College

Hangzhou 310003 China

Fudan University Shanghai Cancer Center

Shanghai 200032 China

Huadong Hospital Affiliated to Fudan University

Shanghai 200400 China

The first hospital of China medical university

Shenyang 110001 China

West China Medical Center of Sichuan University

Sichuan 610041 China

The Second Affiliatted Hospital of Soochow University

Su Zhou 210009 China

Tongi Hospital, Tongi Medical College, Huazhong University

Wuhan 430030 China

First Affiliated Hospital, Xi'an Jiaotong University

Xi'An 710061 China

Healthcare Global (HCG) Hospital

Bangalore 560027 India

Rajiv Gandhi Cancer Institute & Research Centre

Delhi 110085 India

Medanta The Medicity

Gurgaon 122001 India

Tata Memorial Hospital

Mumbai 400012 India

P.D. Hinduja National Hospital and - Medical Research Center

Mumbai 400016 India

All India Institute of Medical Sciences

New Delhi 110029 India

Chiba Cancer Center

Chiba 260-8717 Japan

Hirosaki University School of Medicine & Hospital

Hirosaki 036-8563 Japan

Nara Hospital Kinki University Faculty of Medicine

Ikoma 630-0293 Japan

Kobe University Hospital

Kobe 650-0017 Japan

Dokkyo Medical University Koshigaya Hospital

Koshigaya 343-8555 Japan

NHO Shikoku Cancer Center

Matsuyama 791-0280 Japan

Kindai University Hospital

Osaka-Sayama 589-8511 Japan

Osaka University Hospital

Suita 565-0871 Japan

Seoul National University Hospital

Seoul 03080 Korea, Republic of

Asan Medical Center

Seoul 05505 Korea, Republic of

Samsung Medical Center

Seoul 06351 Korea, Republic of

Gangnam Severance Hospital

Seoul 135-720 Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul 137-701 Korea, Republic of

Hospital Kuala Lumpur

Kuala Lumpur N/A 50586 Malaysia

University Malaya Medical Centre

Kuala Lumpur 59100 Malaysia

Hospital Umum Sarawak

Kuching 93586 Malaysia

Hospital Pulau Pinang

Pulau Pinang 10990 Malaysia

National University Hospital

Singapore 119074 Singapore

Singapore General Hospital

Singapore 169608 Singapore

National Cancer Centre

Singapore 169610 Singapore

Tan Tock Seng Hospital

Singapore 308433 Singapore

Kaohsiung Veterans General Hospital

Kaohsiung Taiwan

China Medical University Hospital

Taichung 403 Taiwan

National Cheng Kung University Hospital

Tainan 70403 Taiwan

National Taiwan University Hospital.

Taipei 10002 Taiwan

Taipei Veterans General Hospital

Taipei 11217 Taiwan

King Chulalongkorn Memorial Hospital

Bangkok 10330 Thailand

Siriraj Hospital

Bangkok 10700 Thailand

Maharaj Nakorn Chiangmai Hospital

Chiang Mai 50200 Thailand

Songkhla Hospital

Songkla 90110 Thailand View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02546908)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer (/clinical-trials/prostate-cancer/94519a-multinational-phase-3-randomized-double-blind-placebo-controlled-efficacyand-safety-study-of-enzalutamide-in-patients-with-nonmetastatic-castrationresistant-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer Condition: Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate Intervention: Drug: Enzalutamide

Drug: Placebo Purpose: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02003924 Sponsor: Pfizer Primary Outcome Measures: Measure: Metastasis Free Survival (MFS)

Time Frame: ≥ 16 weeks

Safety Issue: Secondary Outcome Measures: Measure: Time to Prostate-Specific Antigen (PSA) Progression

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Time to First Use of New Antineoplastic Therapy

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Overall Survival (OS)

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Time to First Use of Cytotoxic Chemotherapy

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: FACT-P Global Score

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Quality of Life as assessed by EQ-5D-5L and QLQ-PR25

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Time to chemotherapy-free disease specific survival

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Time to chemotherapy-free survival

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Time to pain progression

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug

Time Frame: ≥ 16 weeks

Safety Issue:

Measure: PSA response rates

Time Frame: ≥ 16 weeks

Safety Issue: Estimated Enrollment: 1440 Study Start Date: December 2013 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;

Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);

Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;

Progressive disease on androgen deprivation therapy at enrollment;

PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:

PSA doubling time ≤ 10 months;

No prior or present evidence of metastatic disease;

Asymptomatic prostate cancer;

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

Estimated life expectancy ≥ 12 months. Exclusion Criteria: Prior cytotoxic chemotherapy;

Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;

Known or suspected brain metastasis or active leptomeningeal disease;

History of another invasive cancer within 3 years of randomization;

Absolute neutrophil count < 1000/µL, platelet count < 100,000/µL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;

Total bilirubin ≥ 1.5 times the upper limit of normal;

Creatinine > 2 mg/dL (177 µmol/L) at screening;

Albumin < 3.0 g/dL (30 g/L) at screening;

History of seizure or any condition that may predispose to seizure;

Clinically significant cardiovascular disease;

Gastrointestinal disorder affecting absorption;

Major surgery within 4 weeks of randomization;

Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;

Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor. Contact: Pfizer CT.gov Call Center

[email protected]

1-800-718-1021 Locations:

Tucson Arizona 87541 United States

Los Angeles California 90095 United States

Orange California 92868 United States

Englewood Colorado 80113 United States

New Haven Connecticut 06520 United States

Lakeland Florida 33805 United States

Indianapolis Indiana 46202 United States

Jeffersonville Indiana 47130 United States

Lafayette Indiana 47904 United States

Lenexa Kansas 66214 United States

Wichita Kansas 67226 United States

Baltimore Maryland 21229 United States

Ann Arbor Michigan 48109 United States

Troy Michigan 48084 United States

Omaha Nebraska 68130 United States

Brooklyn New York 11215 United States

Newburgh New York 12550 United States

Gastonia North Carolina 28054 United States

Raleigh North Carolina 27607 United States

Middleburg Heights Ohio 44130 United States

Springfield Oregon 97477 United States

Lancaster Pennsylvania 17604 United States

Myrtle Beach South Carolina 29572 United States

Nashville Tennessee 37232 United States

San Antonio Texas 78229 United States

Virginia Beach Virginia 23462 United States

Berazategui Buenos Aires B1880BBF Argentina

Rosario Santa Fe 2000 Argentina

Buenos Aires C1019ABS Argentina

Caba C1181ACH Argentina

Ciudada Autonoma de Buenos Aires C1120AAT Argentina

Cordoba 5016 Argentina

Cordoba X5004FHP Argentina

La Rioja F5300COE Argentina

Santa Fe S2000KZE Argentina

Garran Australian Capital Territory 2605 Australia

Concord New South Wales 2139 Australia

Lismore New South Wales 2480 Australia

New Lambton Heights New South Wales 2305 Australia

North Ride New South Wales 2109 Australia

Port Macquarie New South Wales 2444 Australia

St Leonards New South Wales 2065 Australia

Tweed Heads New South Wales 2485 Australia

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Waratah New South Wales 2298 Australia

Westmead New South Wales 2145 Australia

South Brisbane Queensland 4101 Australia

Southport Queensland 4215 Australia

Woolloongabb Queensland 4102 Australia

Kurralta Park South Australia 5037 Australia

Bentleigh East Victoria 3165 Australia

Box Hill Victoria 3128 Australia

East Melbourne Victoria 3002 Australia

Footscray Victoria 3011 Australia

Heidelberg Victoria 3084 Australia

Malvern Victoria 3144 Australia

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Roeselare 8800 Australia

Linz 4010 Austria

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Bruxelles 1070 Belgium

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Leuven 3000 Belgium

Liege 4000 Belgium

Mons 7000 Belgium

Salvador Bahia 41253 Brazil

Curtiba Parana 81520-060 Brazil

Ljui Rio Grande do Sul 98700-000 Brazil

Passo Fundo Rio Grande do Sul 99074-450 Brazil

Porto Alegre Rio Grande do Sul 90035-074 Brazil

Porto Alegre Rio Grande do Sul 90035-903 Brazil

Campinas Sao Paulo 13083-888 Brazil

Santo Andre Sao Paulo 09060-650 Brazil

Rio de Janeiro 20551-030 Brazil

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Sao Paulo 05652-900 Brazil

Sao Paulo 17210-120 Brazil

Calgary Alberta T2S 3C3 Canada

Edmonton Alberta T6G 1Z2 Canada

Vancouver British Columbia V5Z 1M9 Canada

Winnipeg Manitoba R3E 0V9 Canada

Halifax Nova Scotia B3H2Y9 Canada

Barrie Ontario L4M 7G1 Canada

Hamilton Ontario L8N 4A6 Canada

Kitchener Ontario N2N 2B9 Canada

London Ontario N6A 4L6 Canada

Toronto Ontario M4N 3M5 Canada

Toronto Ontario M5G 2M9 Canada

Greenfield Park Quebec J4V 2H3 Canada

Montreal Quebec H2L 4M1 Canada

Montreal Quebec H3G 1A4 Canada

Québec City G1R 2J6 Canada

Talcahuano Concepcion 4270918 Chile

Santiago 7500921 Chile

Santiago 7630370 Chile

Temunco 4810469 Chile

Vina del Mar 2540364 Chile

Beijing Beijing 100034 China

Beijing Beijing 100142 China

Beijing Beijing 100191 China

Nanjing Jiangsu 210009 China

Suzhou City Jiangsu 215004 China

Wuxi Jiangsu 214023 China

Shanghai Shanghai 200032 China

Shanghai Shanghai 200040 China

Shanghai Shanghai 200080 China

Shanghai Shanghai 200092 China

Xi'an Shanxi 710061 China

Tianjin Tianjin 300211 China

Hangzhou Zhejiang 310009 China

Wenzhou Zhejiang 325000 China

Beijing 100032 China

Beijing 100730 China

Chongqing 400030 China

Guangdong 510150 China

Guangzhou 510120 China

Nanjing 210008 China

Nanjing 210029 China

Wuhan 430071 China

Copenhagen 2200 N Denmark

Frederiksberg 2000 Denmark

Herlev 2730 Denmark

Odense 5000 Denmark

Århus 8200 Denmark

Helsinki 180 Finland

Helsinki 290 Finland

Oulu 90220 Finland

Pori 28500 Finland

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Strasbourg Bas-Rhin 67000 France

Bordeaux Cedex Gironde 33076 France

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Toulouse Haute Garonne 31076 France

Saint Herblain Loire Atlantique 44805 France

Lille Cedex Nord 59037 France

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Pierre Benite Cedex Rhone 69495 France

Strasbourg Rhone 67091 France

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Limoges 87042 France

Lyon Cedex 69003 France

Lyon 69009 France

Montpellier 34298 France

Paris Cedex 15 75908 France

Paris 75248 France

Vandoeuvre les Nancy 54511 France

Nuertingen Baden-Württemberg 72622 Germany

Tubingen Baden-Württemberg 72076 Germany

Weiden Bavaria 92637 Germany

Braunschweig Lower Saxony 38126 Germany

Leer Niedersachsen 26789 Germany

Dresden Saxony 1307 Germany

Berlin 12200 Germany

Hamburg 20246 Germany

Athens 11526 Greece

Athens 11528 Greece

Crete 71201 Greece

Larisa 41110 Greece

Thessaloniki 56403 Greece

Hong Kong Hong Kong

Pokfulam Hong Kong

Belfast BT9 7AB Ireland

Cremona 26100 Italy

Meldola (FC) 47104 Italy

Milano 20133 Italy

Milano 20141 Italy

Modena 41124 Italy

Orbassano 10043 Italy

Padova 35128 Italy

Ravenna 48121 Italy

Roma 152 Italy

Trento 38122 Italy

Goyang-Si 410-769 Korea, Republic of

Hwasun-Gun 519-763 Korea, Republic of

Incheon 405-760 Korea, Republic of

Seoul 110-744 Korea, Republic of

Seoul 120-752 Korea, Republic of

Seoul 135-710 Korea, Republic of

Seoul 135-720 Korea, Republic of

Seoul 138-736 Korea, Republic of

Kuching Sarawak 93586 Malaysia

Kuala Lampur 59100 Malaysia

Amsterdam North Holland 1066cx Netherlands

Dordrecht 3318 AT Netherlands

Eindhoven 5623 EJ Netherlands

Groningen 9713 GZ Netherlands

Maastricht 6229 HX Netherlands

Christchurch 8011 New Zealand

Grafton 1023 New Zealand

Hamilton 4144 New Zealand

Palmerston North 4144 New Zealand

Tauranga 3140 New Zealand

Gdansk 80-952 Poland

Kielce 25-734 Poland

Lublin 20-718 Poland

Mielec 39-300 Poland

Slupsk 76-200 Poland

Wroclaw 51-685 Poland

Wroclaw 53-114 Poland

Wroclaw Poland

Wrocław 50-981 Poland

Moscow 115478 Russian Federation

Moscow 125284 Russian Federation

Republic of Bashkortostan Russian Federation

Belgrade 11000 Serbia

Belgrade 11040 Serbia

Belgrade 11080 Serbia

Singapore 119074 Singapore

Singapore 169610 Singapore

Martin Slovak Republic 036 01 Slovakia

Banska Bystrica 97517 Slovakia

Bratislava 85105 Slovakia

Kosice 4190 Slovakia

Nitra 94901 Slovakia

Presov 8001 Slovakia

Skalica 90980 Slovakia

Zilina 1207 Slovakia

Palma de Mallorca Baleares 07101 Spain

Manresa Barcelona 8243 Spain

Sabadell Barcelona 8208 Spain

San Sebastian Guipuzcoa/Pais Vasco 20014 Spain

Pamplona Navarra 31008 Spain

Barcelona 8003 Spain

Barcelona 8036 Spain

Girona 17007 Spain

Madrid 28006 Spain

Madrid 28033 Spain

Madrid 28041 Spain

Santiago 15706 Spain

Göteborg 41345 Sweden

Malmo 20502 Sweden

Orebro 70185 Sweden

Stockholm 118 53 Sweden

Stockholm 17176 Sweden

Umea 90185 Sweden

Chiayi County 613 Taiwan

Gueishan 333 Taiwan

Kaohsiung 80756 Taiwan

Kaohsiung 807 Taiwan

Kaohsiung 81346 Taiwan

Kaohsiung 81362 Taiwan

Kaohsiung 830 Taiwan

Keelung City 204 Taiwan

Taichung 40447 Taiwan

Taichung 40705 Taiwan

Tainan City 710 Taiwan

Tainan 71004 Taiwan

Taipei City 11217 Taiwan

Taipei 10002 Taiwan

Taipei 11217 Taiwan

Taipei 22060 Taiwan

Bangkok 10330 Thailand

Bangkok 10400 Thailand

Hat Yai 90110 Thailand

Muang 50200 Thailand

Adana 01380 Turkey

Ankara 06600 Turkey

Istanbul 34098 Turkey

Izmir 35110 Turkey

Manisa 45030 Turkey

Chernivtsi 58002 Ukraine

Dnipropetrovsk 49005 Ukraine

Kharkiv 61037 Ukraine

Kyiv 02125 Ukraine

Uzhgorod 88000 Ukraine

Zaporizhzhia 69600 Ukraine

Cambridge Cambridgeshire CB2 0QQ United Kingdom

London Greater London NW1 2BU United Kingdom

Manchester Greater Manchester M20 4BX United Kingdom

Oxford Oxfordshire OX3 7LJ United Kingdom

Sutton Surrey SM2 5PT United Kingdom

Newcastle Tyne & Wear NE7 7DN United Kingdom

Birmingham B15 2TH United Kingdom

Brighton BN2 5BE United Kingdom

Bristol BS2 8ED United Kingdom

London SW3 6JJ United Kingdom

London W12 0NN United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02003924)

{{footer-clinical-trials-navigation}} Published March 6, 2017

A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of BAY1841788 (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (/clinical-trials/prostatecancer/94533-a-multinational-randomised-double-blind-placebo-controlledphase-iii-efficacy-and-safety-study-of-bay1841788-odm-201-in-men-withhigh-risk-non-metastatic-castration-resistant-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of BAY1841788 (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer Condition: Prostate Cancer Non-Metastatic, Castration-Resistant Intervention: Drug: BAY1841788 (ODM-201)

Drug: Placebo Purpose: The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with nonmetastatic castration-resistant prostate cancer. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02200614 Sponsor: Bayer Primary Outcome Measures: Measure: Metastasis-Free Survival

Time Frame: Up to 72 months

Safety Issue: Secondary Outcome Measures: Measure: Overall Survival

Time Frame: Up to 72 months

Safety Issue:

Measure: Time to first symptomatic skeletal event (SSE)

Time Frame: Up to 72 months

Safety Issue:

Measure: Time to initiation of first cytotoxic chemotherapy for prostate cancer

Time Frame: Up to 72 months

Safety Issue:

Measure: Time to pain progression

Time Frame: Up to 72 months

Safety Issue:

Measure: Safety and tolerability of ODM-201

Time Frame: Up to 72 months

Safety Issue: Estimated Enrollment: 1500 Study Start Date: September 12, 2014 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.

Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.

Prostate-specific antigen doubling time of ≤ 10 months and PSA > 2ng/ml.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.

Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.

Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment. Exclusion Criteria: History of metastatic disease at any time or presence of detectable metastases.

Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.

Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.

Use of estrogens or 5- reductase inhibitors or AR inhibitors.

Prior chemotherapy or immunotherapy for prostate cancer.

Use of systemic corticosteroid.

Radiation therapy within 12 weeks before randomisation.

Severe or uncontrolled concurrent disease, infection or co-morbidity.

Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.

Known hypersensitivity to the study treatment or any of its ingredients.

Major surgery within 28 days before randomisation.

Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.

Uncontrolled hypertension.

Prior malignancy.

Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.

Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.

Treatment with any investigational drug within 28 days before randomisation.

Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures. Contact: Bayer Clinical Trials Contact

[email protected]

+49 30 300139003 Locations:

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Greece Glyfada/Athens 16675 Greece Ioannina 45500 Greece Thessaloniki-Moudanion 57001 Greece Budapest 1085 Hungary Budapest 1145 Hungary Budapest 1204 Hungary Debrecen 4032 Hungary Gyor 9024 Hungary Nyiregyhaza 4400 Hungary Szeged 6725 Hungary Szekszard 7100 Hungary Szolnok 5004 Hungary Zalaegerszeg 8900 Hungary Beer Sheva 8410101 Israel Haifa 3339419 Israel Haifa 35152 Israel Jerusalem 9103102 Israel Nahariya 2210001 Israel Ramat Gan 5262000 Israel Tel Aviv 6423906 Israel Zefat 1311001 Israel Chieti Abruzzo 66100 Italy Catanzaro Calabria 88100 Italy Napoli Campania 80131 Italy Napoli Campania Italy Bologna Emilia-Romagna 40138 Italy Forlì-Cesena Emilia-Romagna 47014 Italy Modena Emilia-Romagna 41124 Italy Parma Emilia-Romagna 43126 Italy Roma Lazio 00144 Italy Roma Lazio 00189 Italy Como Lombardia Italy Milano Lombardia 20159 Italy Novara Piemonte 28100 Italy Torino Piemonte 10043 Italy Torino Piemonte 10060 Italy Lecce Puglia 73100 Italy Catania Sicilia 95123 Italy Messina Sicilia 98125 Italy Palermo Sicilia 90127 Italy Arezzo Toscana 52100 Italy Siena Toscana 53100 Italy Nagoya Aichi 466-8560 Japan Nagoya Aichi 466-8650 Japan Kashiwa Chiba 277-8577 Japan Iizuka Fukuoka 820-8505 Japan Kurume Fukuoka 839-0863 Japan Koriyama Fukushima 963-8052 Japan Maebashi Gunma 371-8511 Japan Otake Hiroshima 739-0696 Japan Sapporo Hokkaido 060-8543 Japan Kobe Hyogo 650-0047 Japan Higashiibaraki Ibaraki 311-3193 Japan Kahoku-gun Ishikawa 920-0293 Japan Kanazawa Ishikawa 920-8530 Japan Sagamihara Kanagawa 252-0375 Japan Yokohama Kanagawa 232-0024 Japan Yokosuka Kanagawa 238-8558 Japan Sendai Miyagi 980-8574 Japan Sendai Miyagi 981-8563 Japan Ueda Nagano 386-8610 Japan Kashihara Nara 634-8522 Japan Yufu Oita 879-5593 Japan Kurashiki Okayama 710-8602 Japan Higashiosaka Osaka 578-8588 Japan Osakasayama Osaka 589-8511 Japan Takatsuki Osaka 569-1192 Japan Wako Saitama 351-0102 Japan Hamamatsu Shizuoka 431-3192 Japan Sunto Shizuoka 411-8611 Japan Utsunomiya Tochigi 321-0974 Japan Bunkyo-ku Tokyo 113-8431 Japan Bunkyo-ku Tokyo 113-8603 Japan Itabashi-ku Tokyo 173-0015 Japan Minato-ku Tokyo 105-8471 Japan Mitaka Tokyo 181-8611 Japan Nakano-ku Tokyo 164-8541 Japan Shinjuku-ku Tokyo 160-8582 Japan Sumida-ku Tokyo 130-8587 Japan Ube Yamaguchi 755-8505 Japan Chiba 260-8717 Japan Fukui 910-8526 Japan Hiroshima 730-8518 Japan Kumamoto 861-8520 Japan Kyoto 602-8566 Japan Nagasaki 852-8501 Japan Nagasaki 852-8511 Japan Okayama 700-8558 Japan Osaka 541-8567 Japan Osaka 545-8586 Japan Osaka 558-8558 Japan Toyama 930-0194 Japan Donggu, Gwangju Gwang''yeogsi 501-757 Korea, Republic of Seoul Seoul Teugbyeolsi 135-720 Korea, Republic of Chungchungbuk-do 361-711 Korea, Republic of Daegu 700-701 Korea, Republic of Daegu 700-712 Korea, Republic of Incheon 405-760 Korea, Republic of Seoul 110-744 Korea, Republic of Seoul 120-752 Korea, Republic of Seoul 135-710 Korea, Republic of Seoul 137-701 Korea, Republic of Seoul 138-736 Korea, Republic of Daugavpils LV5401 Latvia Jelgava LV-3001 Latvia Leipaja LV-3401 Latvia Riga LV-1001 Latvia Riga LV-1002 Latvia Riga LV-1038 Latvia Kaunas LT-50009 Lithuania Klaipeda LT-92288 Lithuania Vilnius LT-08660 Lithuania Vilnius LT-08661 Lithuania La Victoria Arequipa Peru Lima 27 Peru Lima LIMA 11 Peru Lima LIMA 18 Peru Lima LIMA 27 Peru Elblag 82-300 Poland Gdansk 80-952 Poland Lodz 90-302 Poland Lodz 90-549 Poland Lublin 20-718 Poland Otwock Poland Rzeszow 35-922 Poland Siedlce 08-110 Poland Warszawa 02-005 Poland Warszawa 02-507 Poland Warszawa 02-616 Poland Warszawa 02-781 Poland Warszawa 04-125 Poland Wroclaw 50-556 Poland Wroclaw 54-144 Poland Santa Maria da Feira Porto 4520-211 Portugal Almada 2801-951 Portugal Braga 4710-243 Portugal Coimbra 3000-075 Portugal Guimaraes 4835-044 Portugal Lisboa 1093-023 Portugal Lisboa 1150-199 Portugal Lisboa 1349-019 Portugal Lisboa 1400-038 Portugal Lisboa 1500-650 Portugal Matosinhos 4464-513 Portugal Porto 4200-072 Portugal Porto 4200-319 Portugal Bucuresti 22328 Romania Bucuresti 41345 Romania Bucuresti 50659 Romania Bucuresti 75000 Romania Cluj-Napoca 400015 Romania Cluj-Napoca 400132 Romania Craiova 200385 Romania Craiova 200642 Romania Oradea 410159 Romania Ploiesti 100337 Romania Targu-Mures 540103 Romania Arkhangelsk 163045 Russian Federation Barnaul 656049 Russian Federation Chelyabinsk 454087 Russian Federation Ivanovo 153040 Russian Federation Kazan 420029 Russian Federation Krasnoyarsk 660022 Russian Federation Moscow 105425 Russian Federation Moscow 117997 Russian Federation Moscow 125284 Russian Federation Moscow 129301 Russian Federation Nizhny Novgorod 603001 Russian Federation Novosibirsk 630099 Russian Federation Obninsk 249036 Russian Federation Omsk 644013 Russian Federation Orenburg 460021 Russian Federation Pyatigorsk 357502 Russian Federation Rostov-on-Don 344022 Russian Federation Saratov 410012 Russian Federation St. Petersburg 191104 Russian Federation St. Petersburg 194017 Russian Federation St. Petersburg 194354 Russian Federation St. Petersburg 197022 Russian Federation St. Petersburg 197758 Russian Federation St. Petersburg 197758 Russian Federation Tyumen 625041 Russian Federation Ufa 450008 Russian Federation Volgograd 400138 Russian Federation Belgrade 11000 Serbia Belgrade 11000 Serbia Belgrade 11080 Serbia Kragujevac 34000 Serbia Nis 18000 Serbia Bratislava 833 05 Slovakia Bratislava 85101 Slovakia Martin 036 59 Slovakia Presov 080 81 Slovakia Skalica 90982 Slovakia Trencin 91101 Slovakia George Eastern Cape 3530 South Africa George Eastern Cape 6530 South Africa Port Elizabeth Eastern Cape 6045 South Africa Johannesburg Gauteng 2193 South Africa Pretoria Gauteng 0083 South Africa Durban Kwazulu-Natal 4126 South Africa Paarl Western Cape 7646 South Africa Rondebosch Western Cape 7700 South Africa Somerset West Western Cape 7130 South Africa Cape Town 7505 South Africa Cape Town 7925 South Africa Elche Alicante 03203 Spain Cádiz Andalucía 11009 Spain L'Hospitalet de Llobregat Barcelona 08907 Spain Sabadell Barcelona 08208 Spain Terrassa Barcelona 08221 Spain Jerez de la Frontera Cádiz 11407 Spain Manacor Illes Baleares 07500 Spain Palma de Mallorca Illes Baleares 07010 Spain Alcorcón Madrid 28922 Spain Fuenlabrada Madrid 28942 Spain Barakaldo Vizcaya 48903 Spain Barcelona 08025 Spain Barcelona 08035 Spain Barcelona 08036 Spain Bilbao 48013 Spain Córdoba 14004 Spain Granada 18012 Spain Granada 18014 Spain Lugo 27003 Spain Madrid 28007 Spain Madrid 28040 Spain Madrid 28041 Spain Madrid 28046 Spain Madrid 28050 Spain Málaga 29010 Spain Pamplona 31008 Spain Salamanca 37007 Spain Sevilla 41013 Spain Sevilla 41071 Spain Valencia 46009 Spain Valencia 46015 Spain Valencia 46026 Spain Valencia 46026 Spain Borås 501 82 Sweden Göteborg 413 45 Sweden Stockholm 171 76 Sweden Uppsala 751 85 Sweden Örebro 701 85 Sweden Kaohsiung City , Taiwan Kaoshiung 813 Taiwan Taichung 40705 Taiwan Taipei 10002 Taiwan Taoyuan 333 Taiwan Ankara 06560 Turkey Ankara 6100 Turkey Istanbul 34730 Turkey Izmir Turkey Manisa 45010 Turkey Sivas 58140 Turkey Chernivtsi 58002 Ukraine Dnipropetrovsk 49102 Ukraine Kharkiv 61037 Ukraine Kryvyi Rih 50048 Ukraine Kyiv 252053 Ukraine Kyiv 2660 Ukraine Uzhgorod 88014 Ukraine Zaporozhye 69600 Ukraine Reading Berkshire RG1 5AN United Kingdom Llanelli Carmarthenshire SA14 8QF United Kingdom Romford Essex RM7 0AG United Kingdom Stevenage Hertfordshire SG1 4AB United Kingdom Maidstone Kent ME16 9QQ United Kingdom Preston Lancashire PR2 4HT United Kingdom Bebington Merseyside CH63 4JY United Kingdom Scunthorpe North East Lincolnshire DN15 7BH United Kingdom Bath Somerset BA1 3NG United Kingdom Stoke-on-Trent Staffordshire ST4 6QG United Kingdom Dudley West Midlands DY1 2HQ United Kingdom Huddersfield West Yorkshire HD3 3EA United Kingdom Wakefield West Yorkshire WF1 4DG United Kingdom Worcester Worcestershire WR5 1DD United Kingdom Cardiff CF14 4XN United Kingdom> Dundee DD2 1UB United Kingdom Glasgow G12 0YN United Kingdom Kent DA2 8DA United Kingdom London SW17 0QT United Kingdom London SW3 6JJ United Kingdom Wrexham LL13 7TD United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02200614)

{{footer-clinical-trials-navigation}} Published March 7, 2017

A Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer. (/clinicaltrials/prostate-cancer/93273-a-pharmacodynamic-pre-surgical-study-ofhedgehog-pathway-inhibition-with-lde225-in-men-with-high-risk-localizedprostate-cancer.html) {{header-clinical-trials-navigation}}

A Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer. Condition: Prostate Cancer Intervention: Drug: LDE225 Purpose: This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label prospective clinical trial in men with localized high-risk prostate cancer undergoing radical prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk of systemic disease progression, by comparing presurgical core-biopsy specimens to tumor tissue harvested at the time of prostatectomy. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02111187 Sponsor: Sidney Kimmel Comprehensive Cancer Center Primary Outcome Measures: Measure: Change from Baseline in Tissue Gli1 Expression levels using qRT-PCR analysis in each group (LDE225 and observation)

Time Frame: Up to 3 Years

Safety Issue: Secondary Outcome Measures: Measure: Pathological effect of presurgical treatment with LDE225

Time Frame: Up to 3 years

Safety Issue:

Measure: Effect of LDE225 on PSA recurrence following prostatectomy

Time Frame: Up to 3 years

Safety Issue:

Measure: Number of Participants with Adverse Events in each group (LDE225 and observation)

Time Frame: Up to 3 years

Safety Issue: Estimated Enrollment: 14 Study Start Date: April 2014 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum 100 Years

Gender: Male Inclusion Criteria: 1. Provide written informed consent prior to any screening procedures. 2. Age 18 years or older. 3. Histologicallydocumented prostatic adenocarcinoma in ≥2 cores 4. ECOG performance status ≤2 5. Localized prostate cancer with at least one of the following NCCN high-risk features:

Gleason sum ≥8

PSA >20 ng/mL

Clinical stage ≥T3 6. Must be a candidate for radical prostatectomy 7. No evidence of known metastatic disease (M0 or Mx allowed) 8. Adequate bone marrow, liver and renal function as specified below:

Absolute neutrophil count (ANC) ≥ 1500/µL

Hemoglobin (Hgb) ≥ 9.0 g/dL

Platelets ≥100,000/µL

Serum total bilirubin ≤ 1.5 x ULN (upper limit of normal)

AST and ALT ≤ 2.5 x ULN

Plasma creatine phosphokinase (CK) < 1.5 x ULN, if known

Serum creatinine ≤ 1.5 x ULN [or 24-hour creatinine clearance ≥ 50ml/min] 9. Patient is able to swallow and retain oral medications Exclusion Criteria: 1. Patients who have had major surgery within 4 weeks of enrollment. 2. Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study. 3. Patients unable to take oral drugs (e.g. lack of physical integrity of the upper GI tract or known malabsorption syndromes). 4. Patients who have previously been treated with LDE225 or other Hh pathway inhibitors 5. Patients who have neuromuscular or muscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are known to cause rhabdomyolysis (such as statins and fibrates), and that cannot be discontinued at least 2 weeks prior to starting LDE225. If it is essential that the patient stays on a statin for hyperlipidemia, only pravastatin may be used with extra caution. Patients should not plan to embark on a new strenuous exercise regimen after initiation of study treatment. (NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment). 6. Patients who have taken part in an experimental drug study within 4 weeks or 5 half-lives (whichever is longer) of initiating treatment with LDE225. 7. Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting LDE225. 8. Patients taking moderate/strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225. 9. No concurrent use of statins (except for pravastatin, if absolutely necessary) 10. No concurrent warfarin or Coumadin-derivatives 11. Impaired cardiac function or significant heart disease, including any one of the following:

Angina pectoris within 3 months

Acute myocardial infarction within 3 months

QTc >450 msec on the screening ECG

A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome

Other clinically significant heart disease (e.g. heart failure, uncontrolled/labile hypertension, or history of poor compliance with an antihypertensive regimen) 12. Patients who are not willing to apply highly effective contraception during the study and through the duration of LDE225 treatment.

Male patients must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the last dose of the study drug. A condom is also required to be used by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid. Sexually active males must be willing to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child during this period. 13. Patients unwilling or unable to comply with the research protocol. Location: Johns Hopkins Hospital

Baltimore Maryland 21205 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02111187)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer (/clinicaltrials/prostate-cancer/96839-a-phase-1-dose-escalation-study-of-mga271-inrefractory-cancer.html) {{header-clinical-trials-navigation}}

A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer Condition: Prostate Cancer, Melanoma, Renal Cell Carcinoma, Triple-negative Breast Cancer, Head and Neck Cancer, Bladder Cancer, Non-small Cell Lung Cancer Intervention: Biological: MGA271 Purpose: The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01391143 Sponsor: MacroGenics Primary Outcome Measures: Measure: Safety

Time Frame: Study Day 50 or 28 days after last infusion

Safety Issue: Secondary Outcome Measures: Measure: Maximum tolerated dose

Time Frame: Study Day 50 or 28 days after last infusion

Safety Issue: Estimated Enrollment: 151 Study Start Date: July 2011 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: All Inclusion Criteria: Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triplenegative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3.

Progressive disease during or after last treatment regimen.

Appropriate treatment history for histological entity.

ECOG Performance Status <= 1.

Life expectancy >= 3 months.

Measurable disease or evaluable disease with relevant tumor marker elevation.

Acceptable laboratory parameters and adequate organ reserve. Exclusion Criteria: Major surgery or trauma within four weeks before enrollment.

Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.

Grade 3 colitis, hepatitis, pneumonitis uveitis, myocarditis, myositis, CNS toxicity or autoimmune related neuromuscular toxicity such as myasthenia gravis associated with the administration of an immune checkpoint inhibitor

Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.

Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.

Vaccination within 2 weeks of enrollment (except for annual flu vaccine).

History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents. Contact: Bing Nie

[email protected]

240-552-8084 Locations: UCLA Hematology-Oncology Clinic

Los Angeles California 90095 United States

Yale Cancer Center

New Haven Connecticut 06520 United States

Moffitt Cancer Center

Tampa Florida 33612 United States

The University of Chicago

Chicago Illinois 60637 United States

Norton Cancer Institute

Louisville Kentucky 40202 United States

University of Maryland

Baltimore Maryland 21201 United States

Neely Center for Clinical Cancer Research, Tufts Medical Center

Boston Massachusetts 02111 United States

Massachusetts General Hospital Cancer Center

Boston Massachusetts 02114 United States

Dana Farber Cancer Institute

Boston Massachusetts 02215 United States

Carolina Biooncology Institute

Huntersville North Carolina 28078 United States

Hospital of the University of Pennsylvania/Abramson Cancer Center

Philadelphia Pennsylvania 19104 United States

Sarah Cannon Research Institute

Nashville Tennessee 37203 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01391143)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer (/clinical-trials/prostatecancer/93275-a-phase-1-study-of-allogeneic-human-bone-marrow-derivedmesenchymal-stem-cells-in-localized-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer Condition: Prostate Cancer Intervention: Biological: Allogeneic Human Mesenchymal Stem Cells Purpose: The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to recipient DNA present in patients' explanted prostate specimens. This will be accomplished via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at engineering MSCs to deliver a toxin to sites of metastatic prostate cancer. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01983709 Sponsor: Sidney Kimmel Comprehensive Cancer Center Primary Outcome Measures: Measure: To quantify the amount of systemically infused (MSC) DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy

Time Frame: Up to 3 years

Safety Issue: Secondary Outcome Measures: Measure: Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.

Time Frame: Up to 3 years

Safety Issue:

Measure: Determine the proportion of MSC to recipient DNA in the peripheral blood at serial time points.

Time Frame: Up to 3 years

Safety Issue:

Measure: Determine the proportion of MSC to recipient DNA within the seminal vesicle.

Time Frame: Up to 3 years

Safety Issue:

Measure: Changes in the Sexual Health Inventory for Men (SHIM) and Expanded Prostate Cancer Index Composite (EPIC) surveys post-prostatectomy.

Time Frame: Up to 3 years

Safety Issue:

Measure: Safety

Time Frame: Up to 3 years

Safety Issue: Estimated Enrollment: 7 Study Start Date: October 2013 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum 100 Years

Gender: Male Inclusion Criteria: 1. (MSC donor cohort):

2. Age ≥18 years, ≤30 years

3. Male sex

4. Donor must meet the selection and Eligibility Criteria: 1. as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and FDA 21 CFR Part 1271 Exclusion Criteria:(MSC donor cohort):

2. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

3. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.

4. Inability to provide informed consent. MSC Recipients Inclusion Criteria (Treatment cohort):

5. Age ≥18 years

6. Eastern cooperative group (ECOG) performance status ≤2

7. Documented histologically confirmed adenocarcinoma of the prostate

8. Gleason score on diagnostic biopsy specimens of ≥ 6

9. ≥ 3 positive cores within diagnostic biopsy specimens

10. At least one prostate core must contain ≥ 30% prostate cancer

11. Scheduled to undergo a prostatectomy at Johns Hopkins

12. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)

13. Sexual Health Inventory in Men (SHIM) score ≥ 17 Exclusion Criteria: 1. (MSC donor cohort):

2. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

3. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.

4. Inability to provide informed consent. MSC Recipients Inclusion Criteria (Treatment cohort):

5. Age ≥18 years

6. Eastern cooperative group (ECOG) performance status ≤2

7. Documented histologically confirmed adenocarcinoma of the prostate

8. Gleason score on diagnostic biopsy specimens of ≥ 6

9. ≥ 3 positive cores within diagnostic biopsy specimens

10. At least one prostate core must contain ≥ 30% prostate cancer

11. Scheduled to undergo a prostatectomy at Johns Hopkins

12. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)

13. Sexual Health Inventory in Men (SHIM) score ≥ 17 Exclusion Criteria (Treatment cohort):

14. Prior radiation therapy to the prostate.

15. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

16. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.

17. Inability to provide informed consent.

18. Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.).

19. Prior history of penicillin or streptomycin allergy.

20. No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study.

21. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)

22. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)

23. Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.

24. History of symptomatic pulmonary dysfunction. Location: Johns Hopkins Hospital

Baltimore Maryland 21205 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01983709)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA) (/clinical-trials/prostate-cancer/93329-aphase-1-trial-for-evaluation-of-the-safety-pharmacokinetics-and-18f-radiationdosimetry-of-ctt1057-a-small-molecule-inhibitor-of-prostate-specificmembrane-antigen-psma.html) {{header-clinical-trials-navigation}}

A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA) Condition: Prostate Cancer Intervention: Drug: CTT1057

Procedure: Prostatectomy Purpose: The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02916537 Sponsor: Cancer Targeted Technology Primary Outcome Measures: Measure: Adverse event frequency as graded by Common Toxicity Criteria version 4.03

Time Frame: 7 days from time of injection

Safety Issue: Secondary Outcome Measures: Measure: Organ dosimetry/tissue uptake of CTT1057 as measured by PET/MR imaging of prostate cancer

Time Frame: Up to six hours from time of injection

Safety Issue:

Measure: Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples

Time Frame: Up to four hours from time of injection

Safety Issue:

Measure: Level of CTT1057 uptake on PET/MR imaging of localized prostate cancer with PSMA protein expression by immunohistochemistry from subsequent radical prostatectomy specimens

Time Frame: 12 weeks

Safety Issue:

Measure: Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue

Time Frame: 4 hours

Safety Issue:

Measure: Sensitivity and specificity of CTT1057 PET imaging on a lesion-by-lesion basis as compared with standard imaging in metastatic prostate cancer

Time Frame: 4 hours

Safety Issue:

Measure: Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

Time Frame: 4 hours

Safety Issue:

Measure: Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

Time Frame: 4 hours

Safety Issue: Estimated Enrollment: 20 Study Start Date: September 2016 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Male patients age ≥18 years old

Histologically confirmed adenocarcinoma of the prostate

Adequate organ function including:

Platelet count of > 50,000/mm3

Neutrophil count of > 1000/mm3

Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation

Proteinuria < 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio

AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)

Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)

ECOG performance status of 0 or 1

Able to provide written informed consent and willing to comply with protocol requirements

No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker

For men of childbearing potential, the use of effective contraceptive methods during the trial and within 6 months following radiotracer injection

Cohort A only (N = 5 evaluable patients):- Planned radical prostatectomy within 12 weeks following protocol scan

No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imaging

Cohort B only:- Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan

Castration-resistant disease as defined by PCWG2 criteria

Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomy Exclusion Criteria: Inadequate venous access per assessment of treating health care provider

Receipt of radioisotope within 5 physical half lives prior to trial enrollment

Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days

Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.

Histologic evidence of small cell prostate cancer or neuroendocrine differentiation in > 50% of biopsy tissue Contact: Kenneth Gao

[email protected]

415 353-9437 Location: University of California San Francisco

San Francisco California 94143 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02916537)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Phase 1 Window of Opportunity Study Investigating the Pharmacodynamic Biomarker Effects of AZD2014 (an mTOR1/2 Inhibitor) Given Prior to Radical Prostatectomy (/clinical-trials/prostate-cancer/93340-a-phase-1window-of-opportunity-study-investigating-the-pharmacodynamic-biomarkereffects-of-azd2014-an-mtor1-2-inhibitor-given-prior-to-radicalprostatectomy.html) {{header-clinical-trials-navigation}}

A Phase 1 Window of Opportunity Study Investigating the Pharmacodynamic Biomarker Effects of AZD2014 (an mTOR1/2 Inhibitor) Given Prior to Radical Prostatectomy Condition: Prostate Cancer Intervention: Drug: AZD2014 Purpose: Patients with localised prostate cancer can be treated by radical prostatectomy (prostate gland removal surgery) or radiotherapy. Around 15% of men with prostate cancer are diagnosed with high risk disease meaning they are more likely to suffer treatment failure, disease progression and mortality. To date little progress has been made towards identifying effective treatment strategies that might delay or prevent disease recurrence in this patient population. Better identification of patients at high risk of relapse and improvements in therapy are therefore research priorities. A protein named Mammalian Target of Rapamycin (mTOR) is known to play an important role in the development of prostate cancer. mTOR forms two protein complexes (mTORC1 and mTORC2) and sends signals helping cancer cells to grow while controlling their energy use. Blocking the function of mTOR, with an inhibitor such as AZD2014, might shut down the supply of energy supply to tumour cells leading to reduced cell growth and potentially slowing the progression of the disease. The purpose of this study is to investigate the molecular pharmacology of AZD2014 treatment given to patients with prostate cancer prior to radical prostatectomy. The feasibility, safety and tolerability of a short course of AZD2014 will also be assessed. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02064608 Sponsor: Cambridge University Hospitals NHS Foundation Trust Primary Outcome Measures: Measure: To measure the amount of inhibition (percentage change from baseline) in mTORC1 and mTORC2 signalling in tumour samples from men with early, high-risk prostate cancer after AZD2014 treatment

Time Frame: 2 weeks

Safety Issue: Secondary Outcome Measures: Measure: To determine the incidence of adverse events due to AZD2014 given prior to radical prostatectomy

Time Frame: 8 weeks unless further observation is clinically indicated

Safety Issue:

Measure: To determine the severity of adverse events due to AZD2014 prior to radical prostatectomy

Time Frame: 8 weeks unless further observation is clinically indicated

Safety Issue: Estimated Enrollment: 23 Study Start Date: October 2014 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Men aged 18 years old or older

ECOG performance status of 0 or 1

Clinical diagnosis of Intermediate (one or more of stage T2, or PSA >10ng/mL, or Gleason score of at least 7) or High Risk Prostate Cancer (one or more of stage T2c, or PSA >20ng/mL, or Gleason score of at least 8)

Patient suitable for radical prostatectomy, following discussion at specialist MDT and subsequent review by surgical team

Willing to use barrier contraceptive method, e.g. condom & spermicide

Adequate bone marrow reserve or organ function (as specified in the study protocol)

Normal chest radiograph and oxygen saturations, OR normal CT thorax Exclusion Criteria: Contraindication to AZD2014 (as specified in the study protocol)

Patients who have experienced any of the following procedures in the past 12 months: coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction; angina pectoris; congestive heart failure (New York Heart Association grade of 2 or above); ventricular arrhythmias requiring continuous therapy; supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; haemorrhagic or thrombotic stroke including transient ischaemic attacks or any other CNS bleeding.

Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 28 days of starting study treatment.

Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study

Potent or moderate inhibitors and inducers of CYP2C8 if taken within the stated wash-out period: Gemfibrozil, trimethoprim, glitazones, montelukast, deferasirox and quercetin (1-week minimum wash out period)

Any haematopoietic growth factors, e.g. G-CSF, GM-CSF, within 4 weeks prior to receiving study drug

As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (as specified in the study protocol)

Abnormal ECHO or MUGA at baseline

Mean resting QTc of 470msec or above (as per local reading)

Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or risk of arrythmic events (examples specified in study protocol). History of Torsades de Pointes.

Patients with Diabetes Type I or uncontrolled Type II as judged by the investigator

Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Unable to provide informed consent Location: Cambridge University Hospitals NHS Foundation Trust

Cambridge Cambridgeshire CB2 0QQ United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02064608)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Phase 2 Clinical Trial Exploring 3-Dimensional Imaging of Androgen Deprivation Induced Osteoporosis, Radiotherapy Hypofractionation and the Prognostic Significance of Micrometastatic Disease in Men With Prostate Cancer (/clinical-trials/prostate-cancer/96900-a-phase-2-clinical-trialexploring-3-dimensional-imaging-of-androgen-deprivation-inducedosteoporosis-radiotherapy-hypofractionation-and-the-prognostic-significanceof-micrometastatic-disease-in-men-with-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase 2 Clinical Trial Exploring 3-Dimensional Imaging of Androgen Deprivation Induced Osteoporosis, Radiotherapy Hypofractionation and the Prognostic Significance of Micrometastatic Disease in Men With Prostate Cancer Condition: Prostate Cancer Purpose: This is a single centre prospective observational noninterventional study of men with histological confirmed prostate cancer, high risk disease and not positive for metastatic disease planned to receive Radiotherapy and 18 months of Androgen Deprivation Therapy (ADT). Although ADT improves the chance of cure, it can also have many side effects. One of these is bone mineral density loss. When this is advanced, it is called osteoporosis. Men with osteoporosis have a higher chance of getting fractures of bones such as the hip and spine. Currently, the best way to measure for osteoporosis is to do a bone mineral density scan using a DEXA scanner. The primary objective of this study is to see if baseline Magnetic Resonance Imager (MRI) and a Computer Tomogram (CT) combined with clinical factors predicts which men are at greater risk of accelerated ADT induced bone mineral density loss than baseline DEXA scanning alone. The data from the patients will be used to construct a model predicting annual rate of bone loss based on baseline imaging, clinical and biochemical characteristics. Secondary aims for this study are as follows: - Evaluating the feasibility, toxicity (acute and late) and efficacy (5 year biochemical control by the Phoenix definition)of multimodality therapy with hypofractionated radiotherapy (giving a larger dose of radiotherapy over a shorter time 5½ weeks compared with a standard 8 week approach). Although used overseas, this 5½ week regimen has not been used widely in Australia, and we would like to see if we gain similar results here as have been reported from the US. - Feasibility and efficacy of a risk adapted duration of neoadjuvant hormonal therapy. Usually, ADT is given for between 19 months before radiotherapy is started but there is no agreement as to which duration is best. This trial aims to tailor the duration of ADT prior to radiotherapy based on blood PSA test results. - Prognostic value of circulating tumour cells (CTCs). This is a blood test which can detect cancer cells in the blood which has been used for patients with metastatic cancer. The presence of CTCs in men with prostate cancer correlated with poorer overall survival. Potentially, high risk prostate cancer patients with CTCs detected may represent a very high risk group and could therefore warrant treatment intensification. To correlate bone marrow changes on MRI with changes in blood counts and patient reported fatigue. Measuring bone marrow may help in predicting not just which patients are at risk of losing bone faster but also of becoming anaemic, and suffering fatigue. A correlation may better explain some of the toxicities associated with ADT. - Implementation of a nomogram based radiotherapy target delineation algorithm. This trial aims to use a decision making tool called a nomogram to help tailor the area to treat in a more standard way. Study Type: Observational Clinical Trials Identifier NCT 8-digits: NCT01418040 Sponsor: Calvary Mater Newcastle, Australia Primary Outcome Measures: Measure: Prediction of ADT induced bone mineral density loss

Time Frame: 6 years

Safety Issue: Secondary Outcome Measures: Measure: Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy

Time Frame: 5 years

Safety Issue:

Measure: To correlate marrow changes on MR with changes in blood counts and patient reported fatigue

Time Frame: 6 years

Safety Issue:

Measure: Prognostic value of circulating tumour cells

Time Frame: 6 years

Safety Issue:

Measure: Implementation of a risk adapted duration of neoadjuvant hormonal therapy

Time Frame: 6 years

Safety Issue:

Measure: Implementation of a nomogram based radiotherapy target delineation algorithm

Time Frame: 6 years

Safety Issue: Estimated Enrollment: 28 Study Start Date: July 2011 Eligibility: Age: minimum N/A maximum N/A

Gender: Male Inclusion Criteria: 1. Patient capable of giving informed consent

2. Histological diagnosis of prostate cancer

3. High risk disease defined by any one of:

4. Baseline PSA>20

5. Gleason grade 8 disease

6. Clinical stage T3-T4

7. Negative conventional staging in the form of a:

8. T99m whole body bone scan

9. CT of the abdomen and pelvis

10. No previous pelvic radiotherapy Exclusion Criteria: 1. History of prior malignancy within the last 5 years with the exception of non-melanomatous skin cancers.

2. ECOG performance status >1

3. Inability to have intraprostatic fiducials inserted.

4. Inability to be given an MRI due to:

5. Implanted magnetic metal eg intraocular metal

6. Pacemaker / Implantable defibrillator

7. Extreme claustrophobia Location: Calvary Mater Newcastle

Waratah New South Wales 2305 Australia View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01418040)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer (/clinical-trials/prostate-cancer/97644a-phase-2-trial-of-nivolumab-plus-ipilimumab-in-men-with-metastaticcastration-resistant-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer Condition: Prostate Cancer Intervention: Biological: Nivolumab

Biological: Ipilimumab Purpose: The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in treatment of metastatic castration-resistant prostate cancer Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02985957 Sponsor: Bristol-Myers Squibb Primary Outcome Measures: Measure: Objective Response Rate (ORR)

Time Frame: Approximately 24 weeks from treatment initiation

Safety Issue:

Measure: Radiographic Progression-Free Survival (rPFS)

Time Frame: Approximately 12 months from treatment initiation

Safety Issue: Secondary Outcome Measures: Measure: Radiographic/Clinical Progression-Free Survival (rcPFS)

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Overall Survival (OS)

Time Frame: Up to 5 years from treatment initiation

Safety Issue:

Measure: Number of patients with adverse events

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Number of patients with serious adverse events

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Number of patients with adverse events leading to discontinuation

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Number of patients with immune-mediated adverse events

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Number of patients with deaths

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Number of patients with laboratory abnormalities

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: Number of patients with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF)

Time Frame: Approximately 12 months from treatment initiation

Safety Issue:

Measure: European Quality of Life- Five Dimensions (EQ-5D-3L) scores

Time Frame: Approximately 12 months from treatment initiation

Safety Issue: Estimated Enrollment: 90 Study Start Date: March 17, 2017 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria)

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)

Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started 28 days before study treatment

Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before Exclusion Criteria:

Cancer that has spread to the liver or brain

Active, known, or suspected autoimmune disease or infection

Prior treatment with any drug that targets T cell co-stimulation pathways(such as checkpoint inhibitors) Other protocol defined inclusion/ Exclusion Criteria: Cancer that has spread to the liver or brain

Active, known, or suspected autoimmune disease or infection

Prior treatment with any drug that targets T cell co-stimulation pathways(such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria could apply Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,

[email protected]

please email: Locations: University of Chicago

Chicago Illinois 60637 United States

Washington University School Of Medicine

Saint Louis Missouri 63110 United States

Icahn School Of Medicine At Mount Sinai

New York New York 10029 United States

Local Institution

New York New York 10065 United States

University Of Pennsylvania

Philadelphia Pennsylvania 19104 United States

MD Anderson Cancer Center

Houston Texas 77030 United States

Local Institution

Clermont-ferrand 63000 France

Local Institution

Lyon 69008 France

Local Institution

Marseille Cedex 9 13273 France

Local Institution

Villejuif 94805 France View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02985957)

{{footer-clinical-trials-navigation}} Published August 1, 2017

A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer (/clinical-trials/prostatecancer/93283-a-phase-i-ii-dose-escalation-study-of-stereotactic-bodyradiation-therapy-in-patients-with-localized-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer Condition: Prostate Adenocarcinoma Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT) Purpose: The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02254746 Sponsor: Centre Hospitalier Universitaire Vaudois Primary Outcome Measures: Measure: Maximum tolerated dose (phase I)

Time Frame: During the first 30 days from the start of treatment

Safety Issue:

Measure: Toxicity (phase II)

Time Frame: 90 days after the first fraction of radiotherapy treatment

Safety Issue: Secondary Outcome Measures: Measure: Efficacy (phase II)

Time Frame: 3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)

Safety Issue:

Measure: Toxicity (phase II)

Time Frame: > 90 days and up to 5 years from the start of protocol treatment

Safety Issue: Estimated Enrollment: 27 Study Start Date: September 2014 Eligibility: Age: minimum 18 Years maximum 99 Years

Gender: All Inclusion Criteria: All patients must be willing and capable to provide informed consent

Histologic confirmation of prostate adenocarcinoma

T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)

No direct evidence of regional or distant metastases

PSA less than or equal to 50 µg/ml

Visible gross tumor at the prostate endorectal coil MRI.

The ultrasound or MRI based volume estimation of the patient's prostate gland no greater than 70g or 70cc

No significant urinary obstructive symptoms; IPSS score must be ≤ 15 (alpha blockers allowed)

Patient must have undergone an endorectal coil magnetic resonance image (MRI) of the prostatic gland (before rectal spacer if any),

Patient must have undergone the following assessments in case of PSA ≥ 20µg/L, and/or T3 tumor and/or Gleason Score ≥ 8:

bone scan

Chest abdominal and pelvis computed tomography (CT) scan

If tumor is localized at less than 3 mm from the rectum a rectal spacer is mandatory. Patient accepts the rectal spacer to be injected before treatment starts

Patient accepts to have one planning MRI after the injection of rectal spacer (without endorectal coil)

Patient accepts the preparation of the bladder (bladder full), before the planning MRI, planning CT and then before each treatment fraction Exclusion Criteria: Previous radiotherapy in the pelvis

Tumor localized at less than 3 mm from the urethra

History of inflammatory colitis (including Crohn's disease and ulcerative colitis)

Prior cancer in the pelvis

Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial Contact: Fernanda Herrera, MD

[email protected]

21 314 46 00 Ext. +41 Location: Centre Hospitalier Universitaire Vaudois

Lausanne 1011 Switzerland View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02254746)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients. (/clinical-trials/prostate-cancer/96912-a-phase-ii-randomizedcontrol-trial-of-conventional-versus-hypofractionated-radiation-regimen-insingle-phase-using-imrt-technique-and-long-term-androgen-suppressiontherapy-in-high-risk-prostate-cancer-patients.html) {{header-clinical-trials-navigation}}

A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients. Condition: High-risk Prostate Cancer Intervention: Radiation: Standard Radiation Treatment

Radiation: Hypofractionated radiation treatment Purpose: Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01488968 Sponsor: AHS Cancer Control Alberta Primary Outcome Measures: Measure: The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients

Time Frame: 5 years

Safety Issue: Secondary Outcome Measures: Measure: The biochemical control (freedom from PSA failure) rate

Time Frame: 10 years

Safety Issue:

Measure: Disease free survival

Time Frame: 10 years

Safety Issue: Estimated Enrollment: 134 Study Start Date: March 2012 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Patient is 18 years of age or older

Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).

Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10

No clinical or radiological evidence of nodal or distant metastasis(es).

In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.

Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.

No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.

No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.

No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%.

Patient signed informed consent. Contact: Albert Murtha

[email protected]

780-432-8518 Location: Cross Cancer Institute

Edmonton Alberta T6G 1Z2 Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01488968)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase II Randomized Trial Evaluating Acute and Late Toxicity of HighDose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer (/clinical-trials/prostatecancer/93281-a-phase-ii-randomized-trial-evaluating-acute-and-late-toxicityof-high-dose-rate-brachytherapy-and-low-dose-rate-brachytherapy-asmonotherapy-in-localized-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase II Randomized Trial Evaluating Acute and Late Toxicity of HighDose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer Condition: Prostate Cancer Intervention: Radiation: Permanent Iodine-125 seed implant

Radiation: High-Dose-rate Prostate Brachytherapy Purpose: High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years. HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress. The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02628041 Sponsor: CHU de Quebec-Universite Laval Primary Outcome Measures: Measure: Quality of Life differences at 3 months using the Expanded Prostate Cancer Index Composite in the urinary domain.

Time Frame: 3 months

Safety Issue: Secondary Outcome Measures: Measure: Quality of life differences using the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.

Time Frame: 24 months

Safety Issue:

Measure: Differences in urinary function using the International Prostate Symptom Score which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.

Time Frame: 24 months

Safety Issue:

Measure: Acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.

Time Frame: 24 months

Safety Issue:

Measure: The dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.

Time Frame: 1month

Safety Issue:

Measure: Local control by performing transrectal-ultrasound guided 12-core prostate rebiopsy at 36 months to assess treatment outcome.

Time Frame: 36 months

Safety Issue:

Measure: The absolute PSA nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.

Time Frame: every 6 months up to 5 years

Safety Issue: Estimated Enrollment: 30 Study Start Date: October 2015 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: 1. -Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the Eligibility Criteria: and have a recent prostate biopsy (within 9 months).

Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA≤20 ng/mL.

Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA ≤ 20 ng/mL and ≤ 60% of positive cores.

Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician.

No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.

Eastern Cooperative Oncology Group status 0-1

No hormonal therapy is accepted.

Prostate volume by Trans-rectal Ultrasound (TRUS) ≤ 60 cc.

Internation Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed) Exclusion Criteria: Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.

Prior or current bleeding diathesis

Previous androgen deprivation therapy within 6 months of the registration.

Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate.

Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).

Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).

Gleason score 7 (4+3), clinical stage≥ T3a, PSA > 20 and > 60% of positive cores. Location: CHU de Québec- L'Hôtel-Dieu de Québec

Québec Quebec G1R 2J6 Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02628041)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer (/clinical-trials/prostatecancer/93331-a-phase-ii-study-of-68ga-rm2-for-pet-ct-of-gastrin-releasingpeptide-receptor-grpr-expression-in-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer Condition: Prostate Cancer Intervention: Radiation: 68Ga-RM2 (RM2)

Device: PET/CT Scan Purpose: The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-ValGly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02559115 Sponsor: Memorial Sloan Kettering Cancer Center Primary Outcome Measures: Measure: localizing tumors

Time Frame: within two weeks prior to the planned prostatectomy

Safety Issue: Estimated Enrollment: 20 Study Start Date: September 2015 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Age ≥18 years

Biopsy proven adenocarcinoma of the prostate

Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included

Planned radical prostatectomy at MSKCC

Multiparametric MRI of the pelvis (performed or planned) as routine care Exclusion Criteria:

Patients meeting any of the following Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for study entry:

Hematologic

Platelets <75K/mcL

ANC <1.0 K/mcL

Hepatic laboratory values

Bilirubin >2.0 x ULN (institutional upper limits of normal)

AST/ALT >2.5 x ULN

Renal laboratory values o Creatinine > 2.0 x ULN

Claustrophobia interfering with MRI and PET/CT imaging

Prior pelvic radiation

Prior androgen deprivation therapy

Patients deemed not surgical candidates due to prohibitive co-morbidities Contact: Wolfgang Weber, MD, PhD

212-639-7373 Location: Memorial Sloan Kettering Cancer Center

New York New York 10065 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02559115)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma. (/clinical-trials/prostate-cancer/98326-a-phase-ii-study-of-docetaxel-beforemedical-castration-with-degarelix-in-patients-with-newly-diagnosedmetastatic-prostatic-adenocarcinoma.html) {{header-clinical-trials-navigation}}

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma. Condition: Metastatic Prostatic Adenocarcinoma Intervention: Drug: Docetaxel

Drug: Degarelix Purpose: The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT03069937 Sponsor: Medical University of South Carolina Primary Outcome Measures: Measure: PSA response at 10 months

Time Frame: 10 months

Safety Issue: Secondary Outcome Measures: Measure: PSA response at 6 months

Time Frame: 6 months

Safety Issue:

Measure: Frequency of adverse events (AEs) using CTCAE v. 4

Time Frame: 10 months

Safety Issue:

Measure: Frequency of disease progression at 12 weeks using PSA

Time Frame: 12 weeks

Safety Issue:

Measure: PSA response at 12 weeks

Time Frame: 12 weeks

Safety Issue:

Measure: Development of castration resistance after initiation with ADT

Time Frame: 10 months

Safety Issue:

Measure: Progression free survival

Time Frame: 34 months

Safety Issue:

Measure: Overall survival (OS)

Time Frame: 34 months

Safety Issue: Estimated Enrollment: 53 Study Start Date: March 1, 2017 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histological or cytological diagnosis of adenocarcinoma of the prostate.

Metastatic disease identified via radiographic assessment by CT scans of the chest, abdomen, pelvis, and nuclear bone scan. MRI may be used if deemed necessary by the investigator. See section 8.5 for more details about radiographic assessment requirements. More specifically, patients must have at least one of the following at time of study enrollment:

Any visceral metastases identified by CT scans or MRI.

Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan.

Lymph node based disease not considered to be within a single radiation therapy port (e.g. at or above the aortic bifurcation.)

Non-castrate testosterone level, >50 ng/dl, at study enrollment.

Age greater than or equal to 18 years.

ECOG performance status 0-2.

Meet the following hematologic criteria within 14 days of enrollment to trial:

Absolute neutrophil count > 1,500/mm3

Hemoglobin > 8.0 g/dl (may be transfused)

Platelet count > 100,000 mm3

Have adequate end-organ function as defined by the following parameters. All lab values must be obtained within 14 days of enrollment to trial:

Creatinine clearance of > 30 ml/min. Creatinine clearance should be determined by the Cockcroft-Gault formula (Appendix A)

AST < 2 x institutional ULN

ALT < 2 x institutional ULN

Total bilirubin < institutional ULN

Agree to use barrier methods of birth control during the docetaxel portion of the protocol and for at least one month after last docetaxel administration.

Informed and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: CNS metastases (brain or leptomeningeal).

Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression.

Active cardiac disease defined as symptomatic congestive heart failure, history of NYHA Class III or IV Heart Failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, active angina pectoris, myocardial infarction or coronary intervention within 6 months of registration.

Prior malignancy requiring systemic therapy within the last 5 years except for treated basal or squamous cell skin cancer. History of low-grade malignancies with limited potential to progress as determined by the primary investigator may be enrolled.

Subjects must not have received any previous androgen deprivation therapy (LHRH agonist or LHRH antagonist) or cytotoxic therapy for prostate cancer in the metastatic setting. Contact: Mike Wheeler

[email protected]

843-792-9321 Location: Medical University of South Carolina

Charleston South Carolina 29425 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03069937)

{{footer-clinical-trials-navigation}} Published September 7, 2017

A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer (/clinical-trials/prostate-cancer/97643-a-phase-ii-study-ofdurvalumab-medi4736-with-or-without-tremelimumab-in-patients-withmetastatic-castration-resistant-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer Condition: Prostate Cancer Intervention: Drug: Durvalumab

Drug: Tremelimumab Purpose: The purpose of this study is to find out the effects of giving durvalumab alone or in combination with tremelimumab on this type of cancer. In addition, this study will look at the side effects of durvalumab when given alone or in combination with tremelimumab. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02788773 Sponsor: Canadian Cancer Trials Group Primary Outcome Measures: Measure: Objective response rate measured by RECIST 1.1 and iRECIST

Time Frame: 2 years

Safety Issue: Secondary Outcome Measures: Measure: Response rate as time to PSA progression

Time Frame: 2 years

Safety Issue:

Measure: Objective Disease progression

Time Frame: 2 years

Safety Issue:

Measure: Number and severity of adverse events

Time Frame: 2 years

Safety Issue: Estimated Enrollment: 74 Study Start Date: August 18, 2016 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Patients must have histologically confirmed adenocarcinoma of the prostate that is castrate resistant.

Disease progression as defined as one or both of the following: PSA Progression: A rising PSA with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 2 ng/ml (ug/L). OR Objective Progression:

RECIST 1.1

PCWG 3 Criteria for bone progression

Patients must be surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 1.7 nM). Patients who have not undergone orchiectomy must continue (or restart if previously discontinued) LHRH therapy throughout the study.

All patients must have a tumour block from their primary or metastatic tumour available and consent to release the block/recently cut slides for correlative analyses and the centre/pathologist must have agreed to the submission of the specimen(s). The site of planned biopsy must not be the measurable lesion.

Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).

All patients must have at least one measurable lesion as defined by RECIST 1.1 that has not been the site of the protocol mandated biopsy. The criteria for defining measurable disease are as follows: CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter; Lymph nodes by CT scan ≥ 15 mm --> measured in short axis

Patients must be ≥ 18 years of age.

ECOG performance status 0 or 1.

Prior Therapy Systemic Therapy: 0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting is permitted. Hormonal Therapy:

Patients must be castrate resistant.

Have failed/progressed on prior abiraterone and/or enzalutamide.

Patients must have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Other therapy: Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.

Systemic corticosteroids are permitted at a dose equivalent to ≤10 mg prednisone daily and are only permitted for reasons other than prostate cancer treatment (ex: fatigue, anorexia, etc); topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted.

Bisphosphonates/denosumab are permitted for treatment of hypercalcemia, osteoporosis and skeletal-related events. Immunotherapy: Patients may not have received prior immune check point inhibitors (anti PDL1 and anti CTL-4). Vaccines and treatment with oncolytic viruses is permissible. Patients must have recovered from all reversible toxicity related to prior systemic therapy (chemotherapy and hormone) and have adequate washout as follows: Longest of one of the following:

Two weeks;

The longer of 30 days or 5 half-lives for investigational agents;

Standard cycle length of standard therapies. Radiation: Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and the date of randomization. Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted. Prior strontium-89 at any time is not permitted Prior Surgery: Prior major surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization, and that wound healing has occurred.

Laboratory Requirements (Must be done within 7 days prior to randomization): Abs Neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN ≤ 5.0 ULN (if patient has liver mets) Serum Creatinine < 1.25 x ULN or Creatinine clearance ≥ 40mL/min

Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone. Female partners of a male subject must use a highly effective method of contraception throughout this period.

Male patients should also refrain from donating sperm during the study and for 6 months after the last dose of durvalumab and tremelimumab or for 3 months after the last dose of durvalumab alone.

Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab or tremelimumab.

Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.

Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the tretment, adverse events, and follow-up.

Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial.

In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization. Exclusion Criteria: Patients with a history of other malignancies requiring concurrent anticancer therapy.

Patients with brain metastases are not eligible.

Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:

Patients with alopecia.

Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).

Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.

History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction.

Live attenuated vaccination administered within 30 days prior to randomization or within 30 days of receiving durvalumab.

History of hypersensitivity to durvalumab or tremelimumab or any excipient. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.

Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.

Concurrent treatment with other investigational drugs or anti-cancer therapy (except LHRH in patients not surgically castrated).

Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:

History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.

Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).

Active peptic ulcer disease or gastritis.

Pneumonitis. Contact: Francisco (Paco) Vera-Badillo

[email protected]

613-533-6430 Locations: BCCA - Cancer Centre for the Southern Interior

Kelowna British Columbia V1Y 5L3 Canada

BCCA - Vancouver Cancer Centre

Vancouver British Columbia V5Z 4E6 Canada

CancerCare Manitoba

Winnipeg Manitoba R3E 0V9 Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton Ontario L8V 5C2 Canada

Cancer Centre of Southeastern Ontario at Kingston

Kingston Ontario K7L 5P9 Canada

London Regional Cancer Program

London Ontario N6A 5W9 Canada

Ottawa Hospital Research Institute

Ottawa Ontario K1H 8L6 Canada

Odette Cancer Centre

Toronto Ontario M4N 3M5 Canada

University Health Network

Toronto Ontario M5G 2M9 Canada

Allan Blair Cancer Centre

Regina Saskatchewan S4T 7T1 Canada

Saskatoon Cancer Centre

Saskatoon Saskatchewan S7N 4H4 Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02788773)

{{footer-clinical-trials-navigation}} Published August 1, 2017

A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate (/clinical-trials/prostate-cancer/96920-a-phase-ii-trial-of-proton-radiationtherapy-of-using-standard-fractionation-for-low-and-low-intermediate-riskadenocarcinoma-of-the-prostate.html) {{header-clinical-trials-navigation}}

A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate Condition: Prostate Cancer Intervention: Procedure: Proton Beam Radiation Therapy

Other: Quality-of-Life assessment

Other: Questionnaire Administration Purpose: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01045226 Sponsor: Abramson Cancer Center of the University of Pennsylvania Primary Outcome Measures: Measure: As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility

Time Frame: 5 years

Safety Issue:

Measure: Acute toxicity as assessed by NCI CTC Version 3.0

Time Frame: Within 60 or 90 days from completion of radiotherapy

Safety Issue: Secondary Outcome Measures: Measure: Late toxicity as assessed by RTOG/EORTC late morbidity scoring system

Time Frame: More than 60 or 90 days from completion of radiotherapy

Safety Issue:

Measure: Biochemical/clinical progression-free survival

Time Frame: Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive

Safety Issue:

Measure: Estimation of event rates

Safety Issue: Estimated Enrollment: 262 Study Start Date: August 2009 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically confirmed prostate adenocarcinoma within 365 days of registration

Clinical stages T1a-T2a N0 M0

For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory

Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion

PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.

Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases

Zubrod status 0-1 documented within 60 days of registration

Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy

Patients must give IRB-approved study-specific informed consent

Patients must complete all required tests listed within the specified time frames

Patients must be able to start treatment within 56 days of registration

Members of all races and ethnic groups are eligible for this trial Exclusion Criteria: Clinical stages T2c or greater

PSA of 10 ng/ml or greater

Gleason score 7 or higher

Evidence of distant metastasis

Evidence of lymph node involvement

Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery

Previous pelvic radiation for prostate cancer

Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy

Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed

Prior systemic chemotherapy for prostate cancer

History of proximal urethral stricture requiring dilatation Contact: Neha Vapiwala, MD

[email protected]

855-216-0098 Location: Abramson Cancer Center of the University of Pennsylvania

Philadelphia Pennsylvania 19104 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01045226)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate Risk Adenocarcinoma of the Prostate (/clinical-trials/prostate-cancer/96925a-phase-ii-trial-of-proton-radiation-therapy-or-intensity-modulated-radiationtherapy-using-mild-hypofractionation-for-low-and-intermediate-riskadenocarcinoma-of-the-prostate.html) {{header-clinical-trials-navigation}}

A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate Risk Adenocarcinoma of the Prostate Condition: Prostate Adenocarcinoma Intervention: Radiation: Proton Therapy

Radiation: IMRT Purpose: This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity. Study Type: Observational Clinical Trials Identifier NCT 8-digits: NCT01352429 Sponsor: Abramson Cancer Center of the University of Pennsylvania Primary Outcome Measures: Measure: Number of Participants with Adverse Events

Time Frame: Within 10 days

Safety Issue:

Measure: Acute Toxicity

Time Frame: Within 60 days of completion of radiotherapy

Safety Issue: Secondary Outcome Measures: Measure: Late toxicity

Time Frame: open-ended

Safety Issue:

Measure: Biochemical/clinicalprogression-free survival

Safety Issue: Estimated Enrollment: 200 Study Start Date: August 2009 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically confirmed prostate adenocarcinoma within 365 days of registration.

Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node > 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.

Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with > 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)

PSA values <20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.

Zubrod (ECOG) status 0-1 documented within 90 days of registration.

Androgen deprivation is at the discretion of the treating radiation oncologist.

Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.

Subjects must be at least 18 years old.

Members of all races and ethnic groups are eligible for this trial. Exclusion Criteria: Clinical stages T3 or greater (AJCC Criteria 6th Ed).

PSA of 20 ng/ml or greater.

Gleason score 8 or higher.

Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)

Evidence of lymph node involvement.

Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.

Previous pelvic radiation for prostate cancer.

Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.

Prior systemic chemotherapy for prostate cancer.

History of proximal urethral stricture requiring dilatation. Contact: Neha Vapiwala, MD

[email protected]

855-216-0098 Location: Abramson Cancer Center of the University of Pennsylvania

Philadelphia Pennsylvania 19004 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01352429)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer (/clinical-trials/prostatecancer/93308-a-phase-ii-prospective-study-of-mri-in-the-reclassification-ofmen-considering-active-surveillance-in-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer Condition: Prostate Cancer Intervention: Device: Multiparametric MRI

Procedure: Prostate biopsy Purpose: Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather, they can be followed closely with regular physical exams, blood work and repeated biopsies of the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be offered at that time. This strategy of delaying treatment until necessary is called active surveillance in prostate cancer. Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay unnecessary treatment in men with less aggressive cancer. Prostate cancer can be slow growing and, for many men, the disease may never progress or cause any symptoms. In other words, many men with prostate cancer will never need any treatment. Treatments for prostate cancer may cause side effects which can affect your quality of life. By monitoring the cancer with regular tests, you can avoid or delay these side effects. Active surveillance is generally suitable for men with low risk early stage prostate cancer that is contained within the prostate gland (localized prostate cancer). If doctors had a better way of identifying who might be best suited for this approach, it would likely become more appealing for more men. In this study, the investigators are looking at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate cancer, which might make a man a poor candidate for active surveillance. To do this, the investigators are collecting data from the MRI scan of men and comparing it to a trans-rectal biopsy performed following the scan. The results of this study will help inform doctors how accurate the MRI is in identifying men who should not be on active surveillance. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01858688 Sponsor: Dana-Farber Cancer Institute Primary Outcome Measures: Measure: Number of participants who have an MP-erMRI finding suggestive of more aggressive disease relative to repeat 12 core TRUS biopsy

Time Frame: 2 years

Safety Issue: Secondary Outcome Measures: Measure: Number of men who have an MP-erMRIs which appear to reclassify them to more extensive or aggressive disease

Time Frame: 2 years

Safety Issue:

Measure: Number of participants to report a change in their health status following the MP-erMRI and rebiopsy o

Time Frame: 2 Years

Safety Issue:

Measure: Report on the tumor grade and extent from the targeted biopsy relative to findings on the MP-erMRI

Time Frame: 2 years

Safety Issue: Estimated Enrollment: 130 Study Start Date: June 2013 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Participants must meet the following criteria on screening examination to be eligible to participate in the study:

The subject will have histologically confirmed prostate cancer with all of the following features:

Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the DF/HCC associated hospitals

Gleason ≤3+3

No tertiary Gleason grade ≥4

≤3 total cores positive

≤50% of any given core involved with cancer

No evidence on biopsy of extracapsular extension

PSA within one month of enrollment: <10 ng/mL

Clinical stage: ≤T2a & N0 or NX & M0

The subject is able and willing to abide by the study protocol or cooperate fully with the investigator or designee

The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document

Age ≥18

Life expectancy of greater than 10 years

Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.

First diagnosis of prostate cancer > 12 months prior to enrollment

Prior prostate cancer-directed therapy including:

androgen deprivation therapy

radiation therapy to the prostate (external beam or brachytherapy)

cryotherapy

high-intensity focused ultrasound (HIFU)

chemotherapy for prostate cancer

Prior transurethral resection of prostate

Subject who is deemed by the treating physician to have a contraindication to definitive treatment

Subjects with a contraindication to an MRI including those with a pacemaker, ferromagnetic aneurysm clip, or cochlear implants

Subjects with a contraindication to receiving Gadolinium containing contrast for the MRI

Conditions which make repeat TRUS biopsies not feasible Contact: Neil E Martin, MD

[email protected]

(617) 732-6433 Locations: Brigham and Women's Hospital

Boston Massachusetts 02215 United States

Dana Farber Cancer Institute

Boston Massachusetts 02215 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01858688)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/POMx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance (/clinical-trials/prostatecancer/93270-a-phase-iia-exploratory-randomized-placebo-controlled-trial-ofpomegranate-fruit-extract-pomx-in-subjects-with-clinically-localized-prostatecancer-undergoing-active-surveillance.html) {{header-clinical-trials-navigation}}

A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/POMx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance Condition: Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer Intervention: Other: Laboratory Biomarker Analysis

Other: Pharmacological Study

Other: Placebo

Drug: Pomegranate-Extract Pill Purpose: This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow disease progression in patients with localized prostate cancer. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02095145 Sponsor: National Cancer Institute (NCI) Primary Outcome Measures: Measure: Change in plasma IGF-1

Time Frame: Baseline to 12 months

Safety Issue: Secondary Outcome Measures: Measure: Change in Gleason grade

Time Frame: Baseline to 1 year

Safety Issue:

Measure: Change in levels of PFD constituents/metabolites

Time Frame: Baseline to up to 1 year

Safety Issue:

Measure: Change in plasma biomarker levels

Time Frame: Baseline to up to 1 year

Safety Issue:

Measure: Change in tissue biomarker levels

Time Frame: Baseline to up to 1 year

Safety Issue:

Measure: Change in tumor volume on prostate biopsy

Time Frame: Baseline to 1 year

Safety Issue:

Measure: Compliance, in terms of the number of pills missed

Time Frame: Up to 1 year

Safety Issue:

Measure: Incidence of adverse events graded per Common Terminology Criteria for Adverse Events (CTCAE)

Time Frame: Up to 1 year

Safety Issue:

Measure: Total serum PSA

Time Frame: Up to 1 year

Safety Issue: Estimated Enrollment: 30 Study Start Date: May 8, 2014 Phase: Phase 2 Eligibility: Age: minimum 21 Years maximum N/A

Gender: Male Inclusion Criteria: Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70 years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in participants >= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study

No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

White blood cells (WBC) >= 3000/mm^3

Platelets >= 100,000 mm^3

Hemoglobin >= 10 g/dL

Total bilirubin =< 1.5 x upper limit of institutional normal

Alkaline phosphatase =< 1.5 x upper limit of institutional normal

Aspartate aminotransferase (AST) =< 1.5 x upper limit of institutional normal

Alanine aminotransferase (ALT) =< 1.5 x upper limit of institutional normal

Serum creatinine within 1.5 x upper limit of institutional normal

Sodium 135-144 mmol/L (inclusive)

Potassium 3.2-4.8 mmol/L (inclusive)

Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential

Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study

Ability to understand, and the willingness to sign, a written informed consent document Exclusion Criteria: Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries

Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years

Prior pelvic radiation for any reason

Participants cannot be taking 5--reductase inhibitors while on study or within 6 months of the baseline study visit

Participants may not be taking carbamazepine (Tegretol)

Participants may not be receiving any other investigational agents

History of allergic reactions attributed to compounds of similar chemical or biologic composition to PFE

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements

Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication Locations: University of Alabama at Birmingham Cancer Center

Birmingham Alabama 35233 United States

Lahey Hospital and Medical Center

Burlington Massachusetts 01805 United States

University of Minnesota/Masonic Cancer Center

Minneapolis Minnesota 55455 United States

University of Rochester

Rochester New York 14642 United States

Urology San Antonio Research PA

San Antonio Texas 78229 United States

University of Wisconsin Hospital and Clinics

Madison Wisconsin 53792 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02095145)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate (/clinical-trials/prostate-cancer/96922-aphase-iii-prospective-randomized-trial-of-standard-fractionation-vs-hypofractionation-with-proton-radiation-therapy-for-low-risk-adenocarcinoma-ofthe-prostate.html) {{header-clinical-trials-navigation}}

A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate Condition: Prostate Cancer Intervention: Radiation: Proton Radiation Hypofractionation

Radiation: Proton Radiation Standard Fractionation Purpose: The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01230866 Sponsor: Proton Collaborative Group Primary Outcome Measures: Measure: To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.

Time Frame: At 5 years post treatment completion +/- 90 days

Safety Issue: Secondary Outcome Measures: Measure: To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.

Time Frame: At 6 months and 2 years post randomization

Safety Issue: Estimated Enrollment: 150 Study Start Date: November 2010 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.

History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.

Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.

PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.

Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.

No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.

Patients must be at least 18 years old.

ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.

IPSS score <= 16.

Patients must give IRB approved, study specific, informed consent.

Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.

Patients must be able to start treatment within 56 days of randomization. Exclusion Criteria: Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.

Previous pelvic radiation for prostate cancer.

Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.

Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.

Prior systemic chemotherapy for prostate cancer.

History of proximal urethral stricture requiring dilatation.

Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).

Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.

Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed). Contact: Corey Woods, RN, MS, CCRC

[email protected]

630-836-8668 Locations: Mayo Clinic Cancer Center

Phoenix Arizona 85054 United States

Northwestern Medicine Chicago Proton Center

Warrenville Illinois 60555 United States

Maryland Proton Treatment Center

Baltimore Maryland 21201 United States

ProCure Proton Therapy Center

Oklahoma City Oklahoma 73142 United States

Hampton University Proton Therapy Institute

Hampton Virginia 23666 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01230866)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer (/clinical-trials/prostatecancer/93263-a-phase-iii-randomized-study-of-hypofractionated-imageguided-volumetric-modulated-arc-radiotherapy-ig-vmat-versusconventionally-fractionated-ig-vmat-in-patients-with-localized-prostatecancer.html) {{header-clinical-trials-navigation}}

A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer Condition: Prostate Cancer Intervention: Radiation: hypofraction

Radiation: convention Purpose: To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02934685 Sponsor: Beijing Hospital Primary Outcome Measures: Measure: Biochemical progression free survival

Time Frame: up to 18 months

Safety Issue: Secondary Outcome Measures: Measure: Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0

Time Frame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT

Safety Issue:

Measure: Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0

Time Frame: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT

Safety Issue:

Measure: Overall Survival

Time Frame: up to 5 years

Safety Issue: Estimated Enrollment: 60 Study Start Date: June 2016 Phase: Phase 3 Eligibility: Age: minimum 50 Years maximum 79 Years

Gender: Male Inclusion Criteria: Age 50-79

Histologically confirmed prostate adenocarcinoma

Clinical stage T1-3N0M0 according to the AJCC 6th edition

Gleason score must be >5

KPS >70

No radical surgery or cryosurgery for prostate cancer Exclusion Criteria: Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)

Evidence of distant metastases

Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

Previous or concurrent cytotoxic chemotherapy for prostate cancer Contact: Qiuzi Zhong

[email protected]

+86 13810428903 Location: Beijing Hospital

Beijing China View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02934685)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer (/clinicaltrials/prostate-cancer/97212-a-phase-iii-randomized-trial-comparingandrogen-deprivation-therapy-tak-700-with-androgen-deprivation-therapybicalutamide-in-patients-with-newly-diagnosed-metastatic-sensitive-prostatecancer.html) {{header-clinical-trials-navigation}}

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer Condition: Prostate Cancer Intervention: Drug: TAK-700

Drug: Bicalutamide Purpose: The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01809691 Sponsor: Southwest Oncology Group Primary Outcome Measures: Measure: Overall survival

Time Frame: 3.2 years

Safety Issue: Estimated Enrollment: 1304 Study Start Date: March 2013 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Clinical diagnosis of metastatic prostate cancer.

Serum testosterone within institutional limits of normal.

PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).

DEXA scan within 2 years prior to registration.

ECG within 42 days prior to registration and QTc interval ≤ 460 msec.

LVEF within 42 days prior to registration and within institutional limits of normal.

Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.

Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.

Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.

Zubrod performance status of 0

2. Zubrod performance status 3 will be allowed if from bone pain only.

≥ 18 years of age.

Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends. Exclusion Criteria: Known brain metastases.

No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.

≥ 6 months since completion of androgen deprivation therapy.

Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.

Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.

≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.

Concurrent use of experimental therapy is not allowed.

≥ 30 days since prior medical castration for metastatic prostate cancer.

If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.

If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).

Prior bilateral orchiectomy.

Concurrent use of LHRH antagonists (e.g. Degarelix)

Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.

Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.

Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.

History of primary and secondary adrenal insufficiency.

Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.

Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.

No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. Contact: Nicki Trevino

[email protected]

614-8808 Ext. 1007 Locations: Veterans Administration Medical Center - Birmingham

Birmingham Alabama 35233 United States

University of Arizona Cancer Center at Saint Joseph's

Phoenix Arizona 85004 United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson Arizona 85704 United States

University of Arizona Cancer Center-North Campus

Tucson Arizona 85719 United States

Southern Arizona Veterans Affairs Health Center

Tucson Arizona 85723 United States

The University of Arizona Medical Center-University Campus

Tucson Arizona 85724 United States

Fowler Family Center for Cancer Care

Jonesboro Arkansas 72401 United States

Veteran's Administration Medical Center

Little Rock Arkansas 72205 United States

Kaiser Permanente-Deer Valley Medical Center

Antioch California 94531 United States

Sutter Auburn Faith Hospital

Auburn California 95602 United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield California 93301 United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley California 94704 United States

Mills - Peninsula Hospitals

Burlingame California 94010 United States

City of Hope Corona

Corona California 92879 United States

Sutter Davis Hospital

Davis California 95616 United States

City of Hope Comprehensive Cancer Center

Duarte California 91010 United States

Kaiser Permanente-Fremont

Fremont California 94538 United States

University Oncology Associates

Fresno California 93701 United States

Kaiser Permanente

Fresno California 93720 United States

UC San Diego Moores Cancer Center

La Jolla California 92093 United States

Loma Linda University Medical Center

Loma Linda California 92354 United States

Veterans Affairs Loma Linda Healthcare System

Loma Linda California 92357 United States

Los Angeles County-USC Medical Center

Los Angeles California 90033 United States

USC / Norris Comprehensive Cancer Center

Los Angeles California 90033 United States

Fremont - Rideout Cancer Center

Marysville California 95901 United States

Mather Veteran Affairs Medical Center

Mather California 95655 United States

Mercy UC Davis Cancer Center

Merced California 95340 United States

Memorial Medical Center

Modesto California 95355 United States

Kaiser Permanente-Modesto

Modesto California 95356 United States

Palo Alto Medical Foundation-Camino Division

Mountain View California 94040 United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View California 94040 United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach California 92663 United States

Sutter Cancer Research Consortium

Novato California 94945 United States

Kaiser Permanente-Oakland

Oakland California 94611 United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange California 92868 United States

Palo Alto Medical Foundation Health Care

Palo Alto California 94301 United States

Feather River Cancer Center

Paradise California 95969 United States

Keck Medical Center of USC Pasadena

Pasadena California 91105 United States

PCR Oncology

Pismo Beach California 93449 United States

Kaiser Permanente-Redwood City

Redwood City California 94063 United States

Kaiser Permanente-Richmond

Richmond California 94801 United States

Kaiser Permanente-Roseville

Roseville California 95661 United States

Sutter Roseville Medical Center

Roseville California 95661 United States

Sutter General Hospital

Sacramento California 95816 United States

University of California Davis Comprehensive Cancer Center

Sacramento California 95817 United States

Kaiser Permanente-South Sacramento

Sacramento California 95823 United States

Kaiser Permanente - Sacramento

Sacramento California 95825 United States

Saint Helena Hospital

Saint Helena California 94574 United States

California Pacific Medical Center-Pacific Campus

San Francisco California 94115 United States

Kaiser Permanente-San Francisco

San Francisco California 94115 United States

UCSF Medical Center-Mount Zion

San Francisco California 94115 United States

UCSF Medical Center-Mission Bay

San Francisco California 94158 United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose California 95119 United States

Kaiser Permanente San Leandro

San Leandro California 94577 United States

Kaiser Permanente-San Rafael

San Rafael California 94903 United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara California 95051 United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz California 95065 United States

Kaiser Permanente-Santa Rosa

Santa Rosa California 95403 United States

Sutter Pacific Medical Foundation

Santa Rosa California 95403 United States

Kaiser Permanente-South San Francisco

South San Francisco California 94080 United States

Kaiser Permanente-Stockton

Stockton California 95210 United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale California 94086 United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee California 96161 United States

Northbay Cancer Center

Vacaville California 95687 United States

Kaiser Permanente Medical Center-Vacaville

Vacaville California 95688 United States

Kaiser Permanente-Vallejo

Vallejo California 94589 United States

Sutter Solano Medical Center/Cancer Center

Vallejo California 94589 United States

Kaiser Permanente-Walnut Creek

Walnut Creek California 94596 United States

Rocky Mountain Cancer Centers-Aurora

Aurora Colorado 80012 United States

The Medical Center of Aurora

Aurora Colorado 80012 United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora Colorado 80045 United States

Boulder Community Hospital

Boulder Colorado 80301 United States

Rocky Mountain Cancer Centers-Boulder

Boulder Colorado 80304 United States

Penrose-Saint Francis Healthcare

Colorado Springs Colorado 80907 United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs Colorado 80907 United States

Porter Adventist Hospital

Denver Colorado 80210 United States

Colorado Blood Cancer Institute

Denver Colorado 80218 United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver Colorado 80218 United States

Rocky Mountain Cancer Centers-Midtown

Denver Colorado 80218 United States

SCL Health Saint Joseph Hospital

Denver Colorado 80218 United States

Rocky Mountain Cancer Centers-Rose

Denver Colorado 80220 United States

Rose Medical Center

Denver Colorado 80220 United States

Colorado Cancer Research Program NCORP

Denver Colorado 80222 United States

Mercy Medical Center

Durango Colorado 81301 United States

Southwest Oncology PC

Durango Colorado 81301 United States

Comprehensive Cancer Care and Research Institute of Colorado LLC

Englewood Colorado 80113 United States

Swedish Medical Center

Englewood Colorado 80113 United States

Mountain Blue Cancer Care Center

Golden Colorado 80401 United States

North Colorado Medical Center

Greeley Colorado 80631 United States

Rocky Mountain Cancer Centers-Greenwood Village

Greenwood Village Colorado 80111 United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood Colorado 80228 United States

Saint Anthony Hospital

Lakewood Colorado 80228 United States

Rocky Mountain Cancer Centers-Littleton

Littleton Colorado 80120 United States

Littleton Adventist Hospital

Littleton Colorado 80122 United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree Colorado 80124 United States

Sky Ridge Medical Center

Lone Tree Colorado 80124 United States

Longmont United Hospital

Longmont Colorado 80501 United States

Rocky Mountain Cancer Centers-Longmont

Longmont Colorado 80501 United States

McKee Medical Center

Loveland Colorado 80539 United States

Parker Adventist Hospital

Parker Colorado 80138 United States

Rocky Mountain Cancer Centers-Parker

Parker Colorado 80138 United States

Saint Mary Corwin Medical Center

Pueblo Colorado 81004 United States

Rocky Mountain Cancer Centers - Pueblo

Pueblo Colorado 81008 United States

Rocky Mountain Cancer Centers-Thornton

Thornton Colorado 80260 United States

SCL Health Lutheran Medical Center

Wheat Ridge Colorado 80033 United States

Greenwich Hospital

Greenwich Connecticut 06830 United States

Yale University

New Haven Connecticut 06520 United States

Eastern Connecticut Hematology and Oncology Associates

Norwich Connecticut 06360 United States

Stamford Hospital/Bennett Cancer Center

Stamford Connecticut 06904 United States

Beebe Medical Center

Lewes Delaware 19958 United States

Medical Oncology Hematology Consultants PA

Newark Delaware 19713 United States

Regional Hematology and Oncology PA

Newark Delaware 19713 United States

Christiana Care Health System-Christiana Hospital

Newark Delaware 19718 United States

Nanticoke Memorial Hospital

Seaford Delaware 19973 United States

MedStar Georgetown University Hospital

Washington, D.C. District of Columbia 20007 United States

MedStar Washington Hospital Center

Washington, D.C. District of Columbia 20010 United States

Sibley Memorial Hospital

Washington, D.C. District of Columbia 20016 United States

George Washington University Medical Center

Washington, D.C. District of Columbia 20037 United States

Veterans Affairs Medical Center -Washington DC

Washington, D.C. District of Columbia 20422 United States

Broward Health Medical Center

Fort Lauderdale Florida 33316 United States

Lakeland Regional Health Hollis Cancer Center

Lakeland Florida 33805 United States

Florida Hospital Orlando

Orlando Florida 32803 United States

UF Cancer Center at Orlando Health

Orlando Florida 32806 United States

Moffitt Cancer Center

Tampa Florida 33612 United States

John B Amos Cancer Center

Columbus Georgia 31904 United States

Atlanta VA Medical Center

Decatur Georgia 30033 United States

Northeast Georgia Medical Center-Gainesville

Gainesville Georgia 30501 United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah Georgia 31405 United States

Hawaii Oncology Inc-Pali Momi

'Aiea Hawaii 96701 United States

Hawaii Cancer Care Inc-POB II

Honolulu Hawaii 96813 United States

Queen's Medical Center

Honolulu Hawaii 96813 United States

University of Hawaii Cancer Center

Honolulu Hawaii 96813 United States

Hawaii Cancer Care Inc-Liliha

Honolulu Hawaii 96817 United States

Hawaii Oncology Inc-Kuakini

Honolulu Hawaii 96817 United States

Kaiser Permanente Moanalua Medical Center

Honolulu Hawaii 96819 United States

Tripler Army Medical Center

Honolulu Hawaii 96859 United States

Saint Alphonsus Cancer Care Center-Boise

Boise Idaho 83706 United States

Kootenai Medical Center

Coeur d'Alene Idaho 83814 United States

Kootenai Cancer Center

Post Falls Idaho 83854 United States

Kootenai Cancer Clinic

Sandpoint Idaho 83864 United States

Rush - Copley Medical Center

Aurora Illinois 60504 United States

Saint Joseph Medical Center

Bloomington Illinois 61701 United States

Illinois CancerCare-Bloomington

Bloomington Illinois 61704 United States

Illinois CancerCare-Canton

Canton Illinois 61520 United States

Illinois CancerCare-Carthage

Carthage Illinois 62321 United States

Centralia Oncology Clinic

Centralia Illinois 62801 United States

Mount Sinai Hospital Medical Center

Chicago Illinois 60608 United States

Northwestern University

Chicago Illinois 60611 United States

University of Illinois

Chicago Illinois 60612 United States

University of Chicago Comprehensive Cancer Center

Chicago Illinois 60637 United States

Weiss Memorial Hospital

Chicago Illinois 60640 United States

Presence Saint Joseph Hospital-Chicago

Chicago Illinois 60657 United States

Cancer Care Center of Decatur

Decatur Illinois 62526 United States

Decatur Memorial Hospital

Decatur Illinois 62526 United States

Heartland Cancer Research NCORP

Decatur Illinois 62526 United States

Crossroads Cancer Center

Effingham Illinois 62401 United States

Illinois CancerCare-Eureka

Eureka Illinois 61530 United States

NorthShore University HealthSystem-Evanston Hospital

Evanston Illinois 60201 United States

Illinois CancerCare-Galesburg

Galesburg Illinois 61401 United States

Northwestern Medicine Cancer Center Delnor

Geneva Illinois 60134 United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview Illinois 60026 United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park Illinois 60035 United States

Hines Veterans Administration Hospital

Hines Illinois 60141 United States

Joliet Oncology-Hematology Associates Limited

Joliet Illinois 60435 United States

Presence Saint Mary's Hospital

Kankakee Illinois 60901 United States

Illinois CancerCare-Kewanee Clinic

Kewanee Illinois 61443 United States

Illinois CancerCare-Macomb

Macomb Illinois 61455 United States

Loyola University Medical Center

Maywood Illinois 60153 United States

Trinity Medical Center

Moline Illinois 61265 United States

Illinois CancerCare-Monmouth

Monmouth Illinois 61462 United States

Community Cancer Center Foundation

Normal Illinois 61761 United States

Illinois CancerCare-Ottawa Clinic

Ottawa Illinois 61350 United States

Ottawa Regional Hospital and Healthcare Center

Ottawa Illinois 61350 United States

Illinois CancerCare-Pekin

Pekin Illinois 61554 United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin Illinois 61554 United States

Methodist Medical Center of Illinois

Peoria Illinois 61603 United States

Proctor Hospital

Peoria Illinois 61614 United States

Illinois CancerCare-Peoria

Peoria Illinois 61615 United States

OSF Saint Francis Medical Center

Peoria Illinois 61637 United States

Illinois CancerCare-Peru

Peru Illinois 61354 United States

Illinois CancerCare-Princeton

Princeton Illinois 61356 United States

West Suburban Medical Center

River Forest Illinois 60305 United States

SwedishAmerican Regional Cancer Center/ACT

Rockford Illinois 61114 United States

Southern Illinois University School of Medicine

Springfield Illinois 62702 United States

Springfield Clinic

Springfield Illinois 62702 United States

Memorial Medical Center

Springfield Illinois 62781 United States

Cancer Care Specialists of Illinois-Swansea

Swansea Illinois 62226 United States

Carle Cancer Center

Urbana Illinois 61801 United States

Northwestern Medicine Cancer Center Warrenville

Warrenville Illinois 60555 United States

Rush-Copley Healthcare Center

Yorkville Illinois 60560 United States

IU Health Bloomington

Bloomington Indiana 47403 United States

Memorial Regional Cancer Center Day Road

Mishawaka Indiana 46545 United States

Memorial Hospital of South Bend

South Bend Indiana 46601 United States

Porter Memorial Hospital

Valparaiso Indiana 46383 United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames Iowa 50010 United States

Mercy Hospital

Cedar Rapids Iowa 52403 United States

Oncology Associates at Mercy Medical Center

Cedar Rapids Iowa 52403 United States

Medical Oncology and Hematology Associates-West Des Moines

Clive Iowa 50325 United States

Alegent Health Mercy Hospital

Council Bluffs Iowa 51503 United States

Genesis Medical Center - East Campus

Davenport Iowa 52803 United States

Medical Oncology and Hematology Associates-Laurel

Des Moines Iowa 50314 United States

Mercy Medical Center - Des Moines

Des Moines Iowa 50314 United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City Iowa 52242 United States

Iowa City VA Healthcare System

Iowa City Iowa 52246 United States

Cancer Center of Kansas - Chanute

Chanute Kansas 66720 United States

Cancer Center of Kansas - Dodge City

Dodge City Kansas 67801 United States

Cancer Center of Kansas - El Dorado

El Dorado Kansas 67042 United States

Cancer Center of Kansas - Fort Scott

Fort Scott Kansas 66701 United States

Saint Catherine Hospital

Garden City Kansas 67846 United States

Heartland Cancer Center

Great Bend Kansas 67530 United States

Saint Rose Ambulatory and Surgery Center

Great Bend Kansas 67530 United States

Hays Medical Center

Hays Kansas 67601 United States

Cancer Center of Kansas-Independence

Independence Kansas 67301 United States

University of Kansas Cancer Center-West

Kansas City Kansas 66112 United States

University of Kansas Cancer Center

Kansas City Kansas 66160 United States

Cancer Center of Kansas-Kingman

Kingman Kansas 67068 United States

Lawrence Memorial Hospital

Lawrence Kansas 66044 United States

Cancer Center of Kansas-Liberal

Liberal Kansas 67905 United States

Cancer Center of Kansas-Manhattan

Manhattan Kansas 66502 United States

Cancer Center of Kansas - McPherson

McPherson Kansas 67460 United States

Cancer Center of Kansas - Newton

Newton Kansas 67114 United States

Olathe Medical Center

Olathe Kansas 66061 United States

Menorah Medical Center

Overland Park Kansas 66209 United States

University of Kansas Cancer Center-Overland Park

Overland Park Kansas 66210 United States

Cancer Center of Kansas - Parsons

Parsons Kansas 67357 United States

Cancer Center of Kansas - Pratt

Pratt Kansas 67124 United States

Cancer Center of Kansas - Salina

Salina Kansas 67401 United States

Salina Regional Health Center

Salina Kansas 67401 United States

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka Kansas 66606 United States

Saint Francis Hospital and Medical Center - Topeka

Topeka Kansas 66606 United States

Topeka VA Hospital

Topeka Kansas 66622 United States

Cancer Center of Kansas - Wellington

Wellington Kansas 67152 United States

Associates In Womens Health

Wichita Kansas 67208 United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita Kansas 67208 United States

Cancer Center of Kansas - Wichita

Wichita Kansas 67214 United States

Via Christi Regional Medical Center

Wichita Kansas 67214 United States

Wichita NCI Community Oncology Research Program

Wichita Kansas 67214 United States

Cancer Center of Kansas - Winfield

Winfield Kansas 67156 United States

University of Kentucky/Markey Cancer Center

Lexington Kentucky 40536 United States

Hematology/Oncology Clinic LLP

Baton Rouge Louisiana 70809 United States

Ochsner Health Center-Summa

Baton Rouge Louisiana 70809 United States

Ochsner Medical Center Kenner

Kenner Louisiana 70065 United States

East Jefferson General Hospital

Metairie Louisiana 70006 United States

Louisiana State University Health Science Center

New Orleans Louisiana 70112 United States

Tulane University Health Sciences Center

New Orleans Louisiana 70112 United States

University Medical Center New Orleans

New Orleans Louisiana 70112 United States

Ochsner Medical Center Jefferson

New Orleans Louisiana 70121 United States

Louisiana State University Health Sciences Center Shreveport

Shreveport Louisiana 71103 United States

Harold Alfond Center for Cancer Care

Augusta Maine 04330 United States

Eastern Maine Medical Center

Bangor Maine 04401 United States

Penobscot Bay Medical Center

Rockport Maine 04856 United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore Maryland 21287 United States

Montgomery General Hospital-Olney

Olney Maryland 20832 United States

Boston Medical Center

Boston Massachusetts 02118 United States

Dana-Farber Cancer Institute

Boston Massachusetts 02215 United States

Steward Saint Elizabeth's Medical Center

Brighton Massachusetts 02135 United States

Lahey Hospital and Medical Center

Burlington Massachusetts 01805 United States

Saint Anne's Hospital

Fall River Massachusetts 02721 United States

Dana Farber Community Cancer Care-Quincy

Quincy Massachusetts 02169 United States

Baystate Medical Center

Springfield Massachusetts 01199 United States

Hickman Cancer Center

Adrian Michigan 49221 United States

Saint Joseph Mercy Hospital

Ann Arbor Michigan 48106-0995 United States

Michigan Cancer Research Consortium NCORP

Ann Arbor Michigan 48106 United States

University of Michigan Comprehensive Cancer Center

Ann Arbor Michigan 48109 United States

Bronson Battle Creek

Battle Creek Michigan 49017 United States

IHA Hematology Oncology Consultants-Brighton

Brighton Michigan 48114 United States

Saint Joseph Mercy Brighton

Brighton Michigan 48114 United States

IHA Hematology Oncology Consultants-Canton

Canton Michigan 48188 United States

Saint Joseph Mercy Canton Health Center

Canton Michigan 48188 United States

IHA Hematology Oncology Consultants-Chelsea

Chelsea Michigan 48118 United States

Saint Joseph Mercy Chelsea

Chelsea Michigan 48118 United States

Saint John Hospital and Medical Center

Detroit Michigan 48236 United States

Green Bay Oncology - Escanaba

Escanaba Michigan 49829 United States

Botsford General Hospital

Farmington Michigan 48334 United States

Cancer Research Consortium of West Michigan NCORP

Grand Rapids Michigan 49503 United States

Mercy Health Saint Mary's

Grand Rapids Michigan 49503 United States

Spectrum Health at Butterworth Campus

Grand Rapids Michigan 49503 United States

Green Bay Oncology - Iron Mountain

Iron Mountain Michigan 49801 United States

West Michigan Cancer Center

Kalamazoo Michigan 49007 United States

Sparrow Hospital

Lansing Michigan 48912 United States

Mercy Health Mercy Campus

Muskegon Michigan 49444 United States

Lakeland Community Hospital

Niles Michigan 49120 United States

Saint Joseph Mercy Oakland

Pontiac Michigan 48341 United States

Lake Huron Medical Center

Port Huron Michigan 48060 United States

Spectrum Health Reed City Hospital

Reed City Michigan 49677 United States

William Beaumont Hospital-Royal Oak

Royal Oak Michigan 48073 United States

Saint Mary's of Michigan

Saginaw Michigan 48601 United States

Marie Yeager Cancer Center

Saint Joseph Michigan 49085 United States

Munson Medical Center

Traverse City Michigan 49684 United States

William Beaumont Hospital - Troy

Troy Michigan 48098 United States

Saint John Macomb-Oakland Hospital

Warren Michigan 48093 United States

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti Michigan 48197 United States

Sanford Clinic North-Bemidgi

Bemidji Minnesota 56601 United States

Fairview Ridges Hospital

Burnsville Minnesota 55337 United States

Mercy Hospital

Coon Rapids Minnesota 55433 United States

Essentia Health Cancer Center

Duluth Minnesota 55805 United States

Fairview-Southdale Hospital

Edina Minnesota 55435 United States

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls Minnesota 56537 United States

Unity Hospital

Fridley Minnesota 55432 United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood Minnesota 55109 United States

Saint John's Hospital - Healtheast

Maplewood Minnesota 55109 United States

Abbott-Northwestern Hospital

Minneapolis Minnesota 55407 United States

Hennepin County Medical Center

Minneapolis Minnesota 55415 United States

Minneapolis Veterans Medical Center

Minneapolis Minnesota 55417 United States

Health Partners Inc

Minneapolis Minnesota 55454 United States

University of Minnesota/Masonic Cancer Center

Minneapolis Minnesota 55455 United States

North Memorial Medical Health Center

Robbinsdale Minnesota 55422 United States

Mayo Clinic

Rochester Minnesota 55905 United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud Minnesota 56303 United States

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park Minnesota 55416 United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park Minnesota 55416 United States

Regions Hospital

Saint Paul Minnesota 55101 United States

United Hospital

Saint Paul Minnesota 55102 United States

Saint Francis Regional Medical Center

Shakopee Minnesota 55379 United States

Lakeview Hospital

Stillwater Minnesota 55082 United States

Ridgeview Medical Center

Waconia Minnesota 55387 United States

Rice Memorial Hospital

Willmar Minnesota 56201 United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury Minnesota 55125 United States

University of Mississippi Medical Center

Jackson Mississippi 39216 United States

Saint Francis Medical Center

Cape Girardeau Missouri 63703 United States

Southeast Cancer Center

Cape Girardeau Missouri 63703 United States

University of Missouri - Ellis Fischel

Columbia Missouri 65212 United States

Barnes-Jewish West County Hospital

Creve Coeur Missouri 63141 United States

Mercy Hospital-Joplin

Joplin Missouri 64804 United States

Truman Medical Center

Kansas City Missouri 64108 United States

Saint Luke's Hospital of Kansas City

Kansas City Missouri 64111 United States

Kansas City Veterans Affairs Medical Center

Kansas City Missouri 64128 United States

The University of Kansas Cancer Center-South

Kansas City Missouri 64131 United States

Research Medical Center

Kansas City Missouri 64132 United States

The University of Kansas Cancer Center-North

Kansas City Missouri 64154 United States

The University of Kansas Cancer Center-Lee's Summit

Lee's Summit Missouri 64064 United States

Delbert Day Cancer Institute at PCRMC

Rolla Missouri 65401 United States

Heartland Regional Medical Center

Saint Joseph Missouri 64506 United States

Saint Louis Cancer and Breast Institute-South City

Saint Louis Missouri 63109 United States

Washington University School of Medicine

Saint Louis Missouri 63110 United States

Missouri Baptist Medical Center

Saint Louis Missouri 63131 United States

Mercy Hospital Saint Louis

Saint Louis Missouri 63141 United States

Siteman Cancer Center - Saint Peters

Saint Peters Missouri 63376 United States

Mercy Hospital Springfield

Springfield Missouri 65804 United States

CoxHealth South Hospital

Springfield Missouri 65807 United States

Billings Clinic Cancer Center

Billings Montana 59101 United States

Saint Vincent Healthcare

Billings Montana 59101 United States

Montana Cancer Consortium NCORP

Billings Montana 59102 United States

Bozeman Deaconess Hospital

Bozeman Montana 59715 United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls Montana 59405 United States

CHI Health Saint Francis

Grand Island Nebraska 68803 United States

CHI Health Good Samaritan

Kearney Nebraska 68847 United States

Nebraska Methodist Hospital

Omaha Nebraska 68114 United States

Alegent Health Immanuel Medical Center

Omaha Nebraska 68122 United States

Alegent Health Bergan Mercy Medical Center

Omaha Nebraska 68124 United States

Alegent Health Lakeside Hospital

Omaha Nebraska 68130 United States

Creighton University Medical Center

Omaha Nebraska 68131 United States

Nevada Cancer Research Foundation CCOP

Las Vegas Nevada 89106 United States

Comprehensive Cancer Centers of Nevada

Las Vegas Nevada 89148 United States

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas Nevada 89169 United States

Renown Regional Medical Center

Reno Nevada 89502 United States

New Hampshire Oncology Hematology PA-Concord

Concord New Hampshire 03301 United States

New Hampshire Oncology Hematology PA-Hooksett

Hooksett New Hampshire 03106 United States

LRGHealthcare-Lakes Region General Hospital

Laconia New Hampshire 03246 United States

Veterans Adminstration New Jersey Health Care System

East Orange New Jersey 07018-1095 United States

Rutgers Cancer Institute of New Jersey

New Brunswick New Jersey 08903 United States

Sparta Cancer Treatment Center

Sparta New Jersey 07871 United States

Lovelace Medical Center-Downtown

Albuquerque New Mexico 87102 United States

University of New Mexico Cancer Center

Albuquerque New Mexico 87102 United States

Hematology Oncology Associates

Albuquerque New Mexico 87106 United States

Memorial Medical Center - Las Cruces

Las Cruces New Mexico 88011 United States

Christus Saint Vincent Regional Cancer Center

Santa Fe New Mexico 87505 United States

Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus

Brooklyn New York 11209 United States

Veterans Affairs Western New York Health Care System-Buffalo

Buffalo New York 14215 United States

Roswell Park Cancer Institute

Buffalo New York 14263 United States

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse New York 13057 United States

Arnot Ogden Medical Center/Falck Cancer Center

Elmira New York 14905 United States

Glens Falls Hospital

Glens Falls New York 12801 United States

Orange Regional Medical Center

Middletown New York 10940 United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York New York 10016 United States

Columbia University/Herbert Irving Cancer Center

New York New York 10032 United States

Weill Medical College of Cornell University

New York New York 10065 United States

University of Rochester

Rochester New York 14642 United States

State University of New York Upstate Medical University

Syracuse New York 13210 United States

Montefiore Medical Center-Weiler Hospital

The Bronx New York 10461 United States

Montefiore Medical Center - Moses Campus

The Bronx New York 10467-2490 United States

Dickstein Cancer Treatment Center

White Plains New York 10601 United States

Mission Hospital-Memorial Campus

Asheville North Carolina 28801 United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte North Carolina 28203 United States

Carolinas HealthCare System NorthEast

Concord North Carolina 28025 United States

Hendersonville Hematology and Oncology at Pardee

Hendersonville North Carolina 28791 United States

Margaret R Pardee Memorial Hospital

Hendersonville North Carolina 28791 United States

Park Ridge Hospital Breast Health Center

Hendersonville North Carolina 28792 United States

Kinston Medical Specialists PA

Kinston North Carolina 28501 United States

Carolinas HealthCare System Union

Monroe North Carolina 28112 United States

Carolinas HealthCare System Cleveland

Shelby North Carolina 28150 United States

Iredell Memorial Hospital

Statesville North Carolina 28677 United States

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem North Carolina 27104 United States

Sanford Bismarck Medical Center

Bismarck North Dakota 58501 United States

Roger Maris Cancer Center

Fargo North Dakota 58122 United States

Sanford Clinic North-Fargo

Fargo North Dakota 58122 United States

Sanford Medical Center-Fargo

Fargo North Dakota 58122 United States

Summa Akron City Hospital/Cooper Cancer Center

Akron Ohio 44304 United States

Summa Barberton Hospital

Barberton Ohio 44203 United States

Adena Regional Medical Center

Chillicothe Ohio 45601 United States

The Christ Hospital

Cincinnati Ohio 45219 United States

University of Cincinnati/Barrett Cancer Center

Cincinnati Ohio 45219 United States

MetroHealth Medical Center

Cleveland Ohio 44109 United States

Ohio State University Comprehensive Cancer Center

Columbus Ohio 43210 United States

Columbus Oncology and Hematology Associates Inc

Columbus Ohio 43214 United States

Riverside Methodist Hospital

Columbus Ohio 43214 United States

Columbus NCI Community Oncology Research Program

Columbus Ohio 43215 United States

Grant Medical Center

Columbus Ohio 43215 United States

The Mark H Zangmeister Center

Columbus Ohio 43219 United States

Mount Carmel Health Center West

Columbus Ohio 43222 United States

Good Samaritan Hospital - Dayton

Dayton Ohio 45406 United States

Miami Valley Hospital

Dayton Ohio 45409 United States

Samaritan North Health Center

Dayton Ohio 45415 United States

Dayton NCI Community Oncology Research Program

Dayton Ohio 45420 United States

Veteran Affairs Medical Center

Dayton Ohio 45428 United States

Delaware Health Center-Grady Cancer Center

Delaware Ohio 43015 United States

Armes Family Cancer Center

Findlay Ohio 45840 United States

Orion Cancer Care

Findlay Ohio 45840 United States

Atrium Medical Center-Middletown Regional Hospital

Franklin Ohio 45005-1066 United States

Dayton Physicians LLC-Atrium

Franklin Ohio 45005 United States

Kettering Medical Center

Kettering Ohio 45429 United States

Saint Rita's Medical Center

Lima Ohio 45801 United States

Marietta Memorial Hospital

Marietta Ohio 45750 United States

Toledo Clinic Cancer Centers-Maumee

Maumee Ohio 43537 United States

Saint Charles Hospital

Oregon Ohio 43616 United States

Mercy Health Perrysburg Cancer Center

Perrysburg Ohio 43551 United States

Southern Ohio Medical Center

Portsmouth Ohio 45662 United States

Springfield Regional Medical Center

Springfield Ohio 45505 United States

Mercy Saint Anne Hospital

Toledo Ohio 43623 United States

Toledo Clinic Cancer Centers-Toledo

Toledo Ohio 43623 United States

Upper Valley Medical Center

Troy Ohio 45373 United States

Saint Ann's Hospital

Westerville Ohio 43081 United States

Wright-Patterson Medical Center

Wright-Patterson Air Force Base Ohio 45433-5529 United States

University of Oklahoma Health Sciences Center

Oklahoma City Oklahoma 73104 United States

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa Oklahoma 74146 United States

Legacy Mount Hood Medical Center

Gresham Oregon 97030 United States

Legacy Good Samaritan Hospital and Medical Center

Portland Oregon 97210 United States

Kaiser Permanente Northwest

Portland Oregon 97227 United States

Oregon Health and Science University

Portland Oregon 97239 United States

Portland Veterans Administration Medical Center

Portland Oregon 97239 United States

Legacy Meridian Park Hospital

Tualatin Oregon 97062 United States

Lehigh Valley Hospital-Cedar Crest

Allentown Pennsylvania 18103 United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem Pennsylvania 18017 United States

Doylestown Hospital

Doylestown Pennsylvania 18901 United States

Penn State Milton S Hershey Medical Center

Hershey Pennsylvania 17033-0850 United States

Thomas Jefferson University Hospital

Philadelphia Pennsylvania 19107 United States

Fox Chase Cancer Center

Philadelphia Pennsylvania 19111 United States

Temple University Hospital

Philadelphia Pennsylvania 19140 United States

Hematology and Oncology Associates of North East Pennsylvania

Scranton Pennsylvania 18508 United States

Reading Hospital

West Reading Pennsylvania 19611 United States

Susquehanna Cancer Center

Williamsport Pennsylvania 17701 United States

AnMed Health Cancer Center

Anderson South Carolina 29621 United States

Roper Hospital

Charleston South Carolina 29401 United States

Charleston Hematology Oncology Associates-Roper

Charleston South Carolina 29403 United States

Charleston Hematology Oncology Associates PA-St. Francis

Charleston South Carolina 29414 United States

Medical University of South Carolina

Charleston South Carolina 29425 United States

Greenville Health System Cancer Institute-Easley

Easley South Carolina 29640 United States

McLeod Regional Medical Center

Florence South Carolina 29506 United States

Saint Francis Hospital

Greenville South Carolina 29601 United States

Greenville Health System Cancer Institute-Butternut

Greenville South Carolina 29605 United States

Greenville Health System Cancer Institute-Faris

Greenville South Carolina 29605 United States

Greenville Memorial Hospital

Greenville South Carolina 29605 United States

Saint Francis Cancer Center

Greenville South Carolina 29607 United States

Greenville Health System Cancer Institute-Eastside

Greenville South Carolina 29615 United States

Self Regional Healthcare

Greenwood South Carolina 29646 United States

Greenville Health System Cancer Institute-Greer

Greer South Carolina 29650 United States

Greenville Health System Cancer Institute-Seneca

Seneca South Carolina 29672 United States

Spartanburg Medical Center

Spartanburg South Carolina 29303 United States

Greenville Health System Cancer Institute-Spartanburg

Spartanburg South Carolina 29307 United States

Sanford Cancer Center-Oncology Clinic

Sioux Falls South Dakota 57104 United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls South Dakota 57117-5134 United States

Erlanger Medical Center

Chattanooga Tennessee 37403 United States

University of Tennessee - Knoxville

Knoxville Tennessee 37920 United States

Meharry Medical College

Nashville Tennessee 37208 United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas Texas 75390 United States

Lyndon Baines Johnson General Hospital

Houston Texas 77026-1967 United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston Texas 77030 United States

Ben Taub General Hospital

Houston Texas 77030 United States

M D Anderson Cancer Center

Houston Texas 77030 United States

Michael E DeBakey VA Medical Center

Houston Texas 77030 United States

MD Anderson Regional Care Center-Katy

Houston Texas 77094 United States

MD Anderson Regional Care Center-Bay Area

Nassau Bay Texas 77058 United States

MD Anderson Regional Care Center-Sugar Land

Sugar Land Texas 77478 United States

MD Anderson Regional Care Center-The Woodlands

The Woodlands Texas 77384 United States

Huntsman Cancer Institute/University of Utah

Salt Lake City Utah 84112 United States

Inova Fairfax Hospital

Falls Church Virginia 22042 United States

Lynchburg Hematology-Oncology Clinic

Lynchburg Virginia 24501 United States

Memorial Hospital Of Martinsville

Martinsville Virginia 24115 United States

Virginia Commonwealth University/Massey Cancer Center

Richmond Virginia 23298 United States

VCU Community Memorial Health Center

South Hill Virginia 23970 United States

Shenandoah Oncology Associates PC

Winchester Virginia 22601 United States

MultiCare Auburn Medical Center

Auburn Washington 98001 United States

PeaceHealth Saint Joseph Medical Center

Bellingham Washington 98225 United States

Highline Medical Center-Main Campus

Burien Washington 98166 United States

Providence Regional Cancer Partnership

Everett Washington 98201 United States

MultiCare Gig Harbor Medical Park

Gig Harbor Washington 98335 United States

Kadlec Clinic Hematology and Oncology

Kennewick Washington 99336 United States

Seattle Cancer Care Alliance at EvergreenHealth

Kirkland Washington 98034 United States

Skagit Valley Hospital

Mount Vernon Washington 98274 United States

Jefferson Healthcare

Port Townsend Washington 98368 United States

MultiCare Good Samaritan Hospital

Puyallup Washington 98372 United States

Minor and James Medical PLLC

Seattle Washington 98104 United States

Fred Hutchinson Cancer Research Center

Seattle Washington 98109 United States

Group Health Cooperative-Seattle

Seattle Washington 98112 United States

Swedish Medical Center-First Hill

Seattle Washington 98122-4307 United States

University of Washington Medical Center

Seattle Washington 98195 United States

Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley Washington 99216 United States

Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane Washington 99204 United States

Rockwood Clinic

Spokane Washington 99220 United States

MultiCare Tacoma General Hospital

Tacoma Washington 98405 United States

Northwest NCI Community Oncology Research Program

Tacoma Washington 98405 United States

Madigan Army Medical Center

Tacoma Washington 98431 United States

Legacy Salmon Creek Hospital

Vancouver Washington 98686 United States

Providence Saint Mary Regional Cancer Center

Walla Walla Washington 99362 United States

West Virginia University Charleston

Charleston West Virginia 25304 United States

Edwards Comprehensive Cancer Center

Huntington West Virginia 25701 United States

Langlade Hospital and Cancer Center

Antigo Wisconsin 54409 United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington Wisconsin 53105 United States

Marshfield Clinic-Chippewa Center

Chippewa Falls Wisconsin 54729 United States

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire Wisconsin 54701 United States

Sacred Heart Hospital

Eau Claire Wisconsin 54701 United States

Aurora Health Center-Fond du Lac

Fond du Lac Wisconsin 54937 United States

Aurora Health Care Germantown Health Center

Germantown Wisconsin 53022 United States

Aurora Cancer Care-Grafton

Grafton Wisconsin 53024 United States

Green Bay Oncology at Saint Vincent Hospital

Green Bay Wisconsin 54301-3526 United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay Wisconsin 54301 United States

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay Wisconsin 54303 United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay Wisconsin 54303 United States

Aurora BayCare Medical Center

Green Bay Wisconsin 54311 United States

Mercy Health System

Janesville Wisconsin 53547 United States

UW Cancer Center Johnson Creek

Johnson Creek Wisconsin 53038 United States

Aurora Cancer Care-Kenosha South

Kenosha Wisconsin 53142 United States

Gundersen Lutheran Medical Center

La Crosse Wisconsin 54601 United States

Marshfield Clinic - Ladysmith Center

Ladysmith Wisconsin 54848 United States

University of Wisconsin Hospital and Clinics

Madison Wisconsin 53792 United States

Holy Family Memorial Hospital

Manitowoc Wisconsin 54221 United States

Aurora Bay Area Medical Group-Marinette

Marinette Wisconsin 54143 United States

Vince Lombardi Cancer Clinic-Marinette

Marinette Wisconsin 54143 United States

Marshfield Clinic

Marshfield Wisconsin 54449 United States

Saint Joseph's Hospital

Marshfield Wisconsin 54449 United States

Aurora Cancer Care-Milwaukee

Milwaukee Wisconsin 53209 United States

Aurora Saint Luke's Medical Center

Milwaukee Wisconsin 53215 United States

Froedtert and the Medical College of Wisconsin

Milwaukee Wisconsin 53226 United States

Aurora Sinai Medical Center

Milwaukee Wisconsin 53233 United States

Marshfield Clinic-Minocqua Center

Minocqua Wisconsin 54548 United States

Cancer Center of Western Wisconsin

New Richmond Wisconsin 54017 United States

Green Bay Oncology - Oconto Falls

Oconto Falls Wisconsin 54154 United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh Wisconsin 54904 United States

Aurora Cancer Care-Racine

Racine Wisconsin 53406 United States

Marshfield Clinic at James Beck Cancer Center

Rhinelander Wisconsin 54501 United States

Saint Mary's Hospital

Rhinelander Wisconsin 54501 United States

Marshfield Clinic-Rice Lake Center

Rice Lake Wisconsin 54868 United States

HSHS Saint Nicholas Hospital

Sheboygan Wisconsin 53081 United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan Wisconsin 53081 United States

Marshfield Clinic Cancer Care at Saint Michael's Hospital

Stevens Point Wisconsin 54481 United States

Saint Michael's Hospital

Stevens Point Wisconsin 54481 United States

Marshfield Clinic Stevens Point Center

Stevens Point Wisconsin 54482 United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay Wisconsin 54235-1495 United States

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay Wisconsin 54235 United States

Aurora Medical Center in Summit

Summit Wisconsin 53066 United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers Wisconsin 54241 United States

Aurora Cancer Care-Waukesha

Waukesha Wisconsin 53188 United States

Aspirus Regional Cancer Center

Wausau Wisconsin 54401 United States

Marshfield Clinic-Wausau Center

Wausau Wisconsin 54401 United States

Aurora Cancer Care-Milwaukee West

Wauwatosa Wisconsin 53226 United States

Aurora West Allis Medical Center

West Allis Wisconsin 53227 United States

Diagnostic and Treatment Center

Weston Wisconsin 54476 United States

Marshfield Clinic - Weston Center

Weston Wisconsin 54476 United States

Aspirus UW Cancer Center

Wisconsin Rapids Wisconsin 54494 United States

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids Wisconsin 54494 United States

Billings Clinic-Cody

Cody Wyoming 82414 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01809691)

{{footer-clinical-trials-navigation}} Published July 12, 2017

A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial (/clinical-trials/prostatecancer/96906-a-phase-iii-randomized-trial-of-mri-mapped-dose-escalatedsalvage-radiotherapy-post-prostatectomy-the-maps-trial.html) {{header-clinical-trials-navigation}}

A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial Condition: Prostate Cancer, Prostate Adenocarcinoma Intervention: Radiation: Standard Salvage Radiation Treatment (SSRT)

Radiation: Mapped Tumor Salvage RT (MTSRT)

Behavioral: Expanded Prostate Cancer Index Composite-SF12

Behavioral: Memory Anxiety Scale for Prostate Cancer patients

Behavioral: International Prostate Symptom Score (IPSS) Purpose: 1. The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is related to long-term outcome biochemically. 2. Biomarker expression levels differ in the DCE-MRI enhancing and nonenhancing tumor regions. 3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01411345 Sponsor: University of Miami Primary Outcome Measures: Measure: Rate of PSA Response to Protocol Therapy

Time Frame: 21 months Post-Completion of Protocol Therapy

Safety Issue: Secondary Outcome Measures: Measure: Rate of Acute and Late Toxicity

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Impact of Protocol Therapy on Study Participant Health-Related Quality of Life (HRQOL)

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Impact of Protocol Therapy on Study Participant Prostate Cancer-Specific Anxiety

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Impact of Protocol Therapy on Study Participant Prostate Cancer-specific Quality of Life (QOL).

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Rate of Biochemical and Clinical Failure

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Rate of Failure-free Survival (FFS)

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Rate of Overall survival (OS)

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Measurement of Tissue Biomarker Expression

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue:

Measure: Incidence and relationship of circulating DNA and tumor cells to tissue biomarkers

Time Frame: Up to 5.25 years post-Protocol Therapy

Safety Issue: Estimated Enrollment: 80 Study Start Date: July 12, 2012 Eligibility: Age: minimum 35 Years maximum 85 Years

Gender: Male Inclusion Criteria: A. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment.

B. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.

C. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.

D. MRI detectable lesion in prostate bed. DCE-MRI enhancing lesion in the prostate bed should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to enrollment.

E. No evidence of metastatic (regional or distant) disease on the pelvic MRI.

F. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to enrollment.

G. No previous pelvic radiotherapy.

H. Serum total testosterone is within 40% of normal assay limits, taken within 34 months prior to enrollment. Patient who have been started on androgen deprivation therapy (ADT) prior to signing consent are not required to have serum testosterone with the range outlined; but, should have a serum testosterone level recorded prior to enrollment.

I. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.

J. Ability to understand and the willingness to sign a written informed consent document.

K. Zubrod performance status < 2.

L. Patients must agree to fill out quality of life/psychosocial questionnaires.

M. Age ≥ 35 and ≤ 85 years. Exclusion Criteria: A. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed). Location: University of Miami

Miami Florida 33136 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01411345)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial (/clinical-trials/prostatecancer/96907-a-phase-iii-trial-of-hypofractionated-external-beam-imageguided-highly-targeted-radiotherapy-the-height-trial.html) {{header-clinical-trials-navigation}}

A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial Condition: Prostate Cancer, Prostate Adenocarcinoma Intervention: Radiation: SIMRT

Radiation: HTIMRT

Behavioral: EPIC SF-12 Questionnaire

Behavioral: MAX-PC Questionnaire

Behavioral: IPSS Questionnaire Purpose: 1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the dominant tumor lesion in the prostate as identified by multiparametric MRI will increase tumor eradication from the prostate. 2. Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome. 3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Quality of life will not differ significantly between the treatment arms. 5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01411332 Sponsor: University of Miami Primary Outcome Measures: Measure: Rate of prostate biopsy positivity in patients receiving HTIMRT versus patients receiving SIMRT at 2 years after all therapy.

Time Frame: 2 years post-therapy

Safety Issue: Secondary Outcome Measures: Measure: Rate of acute and late toxicity in patients receiving HTIMRT.

Time Frame: 5.25 years

Safety Issue:

Measure: Rate of influence of HTIMRT on patients' on quality of life.

Time Frame: 5.25 years

Safety Issue:

Measure: Quantification of biomarker expression in different prostate tumor regions.

Time Frame: 5.25 years

Safety Issue:

Measure: Incidence and relationship of circulating free DNA and tumor cells to tissue biomarkers and prostate biopsy positivity.

Time Frame: 2 years post-completion of therapy

Safety Issue:

Measure: Rate of Biochemical Failure, Clinical Failure and Failure-Free Survival (FFS) in Patients

Time Frame: 5.25 years

Safety Issue:

Measure: Rate of Overall Survival (OS)

Time Frame: 5.25 years

Safety Issue: Estimated Enrollment: 72 Study Start Date: October 31, 2011 Eligibility: Age: minimum 35 Years maximum 85 Years

Gender: Male Inclusion Criteria: A. Biopsy confirmed adenocarcinoma of the prostate.

B. T1-T3a disease based on digital rectal exam. 1. T1a is permitted if peripheral zone biopsies are positive. 2. T3a disease based on MRI is acceptable.

C. No evidence of metastasis by any clinical criteria or available radiographic tests.

D. Gleason score 6-8.

E. Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be recommended to receive short term ADT in conjunction with RT. When given, the ADT recommended to begin after fiducial marker placement, if applicable; however, ADT is permitted to have been started up to two months prior to the signing of consent. 1. Patients with Gleason score 8 disease must have <40 of the diagnostic tumor tissue involved with tumor. 2. Patients with Gleason score ≤7 may be treated with 4-6 (±2 months) months of ADT.

F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to ≤100 with antibiotics, this is acceptable for enrollment.

G. If PSA is >15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be obtained ≤4 months before enrollment and should be without evidence of metastasis. A questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for metastasis.

H. No previous pelvic radiotherapy

I. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)

J. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.

K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a 1.5T or 3.0T MRI (3.0T preferable), that total in volume <33% of the prostate within 3 months prior to enrollment. a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate and pelvis is required prior to protocol consideration

L. Ability to understand and the willingness to sign a written informed consent document

M. Zubrod performance status <2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod)

N. Willingness to fill out quality of life/psychosocial forms.

O. Age ≥35 and ≤85 years.

P. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay limit and x=.04*upper assay limit + upper assay limit),, taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.

Q. Serum liver function tests (LFTs) taken within 3 months of enrollment.

R. Complete blood counts taken within 3 months of enrollment. Exclusion Criteria: A. Previous pelvic radiotherapy.

B. Previous history of radical prostatectomy.

C. Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is not eligible

D. Not willing to fill out quality of life/psychosocial questionnaires. Location: University of Miami

Miami Florida 33136 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01411332)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor a (/clinical-trials/prostate-cancer/97640-aphase-iii-multicenter-randomized-study-of-atezolizumab-anti-pd-l1-antibodyin-combination-with-enzalutamide-versus-enzalutamide-alone-in-patientswith-metastatic-castration-resistant-prostate-cancer-after-failure-of-anandrogen-synthesis-inhibitor-a.html) {{header-clinical-trials-navigation}}

A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen Condition: Prostatic Neoplasms, Castration-Resistant Intervention: Drug: Atezolizumab

Drug: Enzalutamide Purpose: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (antiprogrammed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT03016312 Sponsor: Hoffmann-La Roche Primary Outcome Measures: Measure: Overall surivival (OS)

Time Frame: Baseline until death from any cause (up to approximately 42 months)

Safety Issue: Secondary Outcome Measures: Measure: Percentage of Participants who Survived at Month 12 and 24

Time Frame: Months 12, 24

Safety Issue:

Measure: Time to Cancer-Related Pain Progression, as Assessed Using Modified Brief Pain Inventory (BPI)

Time Frame: Baseline until disease progression (up to approximately 42 months)

Safety Issue:

Measure: Time to First Symptomatic Skeletal Event (SSE)

Time Frame: Baseline up to end of study (up to approximately 42 months)

Safety Issue:

Measure: Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria

Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)

Safety Issue:

Measure: Percentage of Participants Who are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria

Time Frame: Months 6, 12

Safety Issue:

Measure: Immune-Modified rPFS, as Assessed by the Investigator as per PCWG3 Criteria and Immune-Modified Response Evaluation Criteria in Solid Tumors (RECIST)

Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)

Safety Issue:

Measure: Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline

Time Frame: Baseline until disease progression (up to approximately 42 months)

Safety Issue:

Measure: Time to PSA Progression, Assessed as per PCWG3 Criteria

Time Frame: Baseline until disease progression (up to approximately 42 months)

Safety Issue:

Measure: Percentage of Participant With Objective Response, as Determined by the Investigator Through use of PCWG3 Criteria

Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)

Safety Issue:

Measure: Percentage of Participant With Objective Response, as Determined by the Investigator Through use of Immune-Modified RECIST

Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)

Safety Issue:

Measure: Percentage of Participants With Adverse Events

Time Frame: Baseline up to end of study (up to approximately 42 month

Safety Issue:

Measure: Minimum Observed Serum Concentration (Cmin) of Atezolizumab

Time Frame: Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)

Safety Issue:

Measure: Maximum Observed Serum Concentration (Cmax) of Atezolizumab

Time Frame: Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)

Safety Issue:

Measure: Plasma Concentration of Enzalutamide

Time Frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8

Safety Issue:

Measure: Plasma Concentration of N-Desmethyl Enzalutamide

Time Frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8

Safety Issue:

Measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

Time Frame: Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months

Safety Issue:

Measure: Time to Initiation or Increased Opiate Analgesic Use

Time Frame: Baseline up to end of study (up to approximately 42 months)

Safety Issue: Estimated Enrollment: 730 Study Start Date: January 11, 2017 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Life expectancy greater than or equal to (>/=) 3 months

Histologically confirmed adenocarcinoma of the prostate

Known castrate-resistant disease with serum testosterone level less than or equal to (

Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration

One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen

Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate cancer

Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing

Adequate hematologic and end organ function Exclusion Criteria: Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM201)

Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment

Treatment with abiraterone within 2 weeks prior to study treatment

Structurally unstable bone lesions suggesting impending fracture

Known or suspected brain metastasis or active leptomeningeal disease

Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study

Active or history of autoimmune disease or immune deficiency

Prior allogeneic stem cell or solid organ transplantation

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies

Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment

Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study

History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack Contact: Reference Study ID Number: CO39385 www.roche.com/about_roche/roche_worldwide.htm

[email protected]

888-662-6728 (U.S. and Canada) Locations: City of Hope Medical Grp Inc.

Duarte California 91010 United States

University of California San Diego

La Jolla California 92093 United States

Kaiser Permanente San Diego - Los Angeles

Los Angeles California 90027 United States

USC Norris Cancer Center

Los Angeles California 90033 United States

USC/Westside Cancer Ctr

Los Angeles California 90033 United States

Prostate Oncology Specialists

Marina Del Rey California 90292 United States

UC Irvine Medical Center

Orange California 92868 United States

Pacific Hematology Oncology Assocociates

San Francisco California 94115 United States

University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center

San Francisco California 94158 United States

University of Colorado; Division of Medical Oncology

Aurora Colorado 80045 United States

University of Connecticut Health Center

Farmington Connecticut 06030 United States

Hartford Hospital

Hartford Connecticut 06102 United States

Yale School of Medicine

New Haven Connecticut 06510 United States

Stamford Hospital; BCC, MOHR

Stamford Connecticut 06904 United States

Lynn Cancer Institute/Boca Raton Regional Hospital

Boca Raton Florida 33486 United States

SCRI Florida Cancer Specialists South

Fort Myers Florida 33916 United States

Baptist Health Medical Group Oncology, LLC

Miami Florida 33176 United States

Florida Cancer Specialist, North Region

Saint Petersburg Florida 33705 United States

SCRI Florida Cancer Specialists East

Tallahassee Florida 32308 United States

Investigative Clin Rsch of IN

Indianapolis Indiana 46260 United States

Associates in Oncology/Hematology P.C.

Rockville Maryland 20850 United States

Massachusetts General Hospital

Boston Massachusetts 02114 United States

Beth Israel Deaconess Medical Center

Boston Massachusetts 02215 United States

Dana-Farber Cancer Institute

Boston Massachusetts 02215 United States

Karmanos Cancer Institute..

Detroit Michigan 48201 United States

HCA Midwest Division

Kansas City Missouri 64132 United States

St. Vincent Frontier Cancer Center

Billings Montana 59101 United States

Nebraska Cancer Specialists; Oncology Hematology West, PC

Omaha Nebraska 68130 United States

Urology Cancer Center & GU Research Network

Omaha Nebraska 68130 United States

Comprehensive Cancer Centers of Nevada

Las Vegas Nevada 89128 United States

MSKCC at Basking Ridge

Basking Ridge New Jersey 07920 United States

MD Anderson Cancer Center at Cooper

Camden New Jersey 8103 United States

Hunterdon Medical Center

Flemington New Jersey 08822 United States

New York Oncology Hematology, P.C.

Albany New York 12208 United States

MSKCC @ Commack

Commack New York 11725 United States

MSKCC @ West Harrison

Harrison New York 10604 United States

Columbia University Medical Center

New York New York 10032 United States

Memorial Sloan-Kettering Cancer Center

New York New York United States

MSKC @ Rockville

Rockville Centre New York 11570 United States

Oncology Hematology Care, Inc.

Cincinnati Ohio 45230 United States

James Cancer Hospital;Solove Research Institute

Columbus Ohio 43210 United States

Good Samaritan North Health Center

Dayton Ohio 45415 United States

Willamette Valley Cancer Ctr - 520 Country Club

Eugene Oregon 97401-8122 United States

Lehigh Valley Health Network

Allentown Pennsylvania 18103 United States

Penn State Milton S. Hershey Medical Center

Hershey Pennsylvania 17033 United States

University of Pennsylvania Health System; Cancer Center

Philadelphia Pennsylvania 19104 United States

Allegheny Cancer Center

Pittsburgh Pennsylvania 15212 United States

University of Pittsburgh Cancer Institute; Division of Medical Oncology

Pittsburgh Pennsylvania 15232 United States

Miriam Hospital

Providence Rhode Island 02906 United States

Charleston Hematology Oncology

Charleston South Carolina 29414 United States

Carolina Urologic Research Center

Myrtle Beach South Carolina 29572 United States

SCRI Tennessee Oncology Chattanooga

Chattanooga Tennessee 37404 United States

Tennessee Onc., PLLC - SCRI

Nashville Tennessee 37203 United States

Vanderbilt University Medical Center

Nashville Tennessee 37232 United States

Texas Oncology Cancer Center

Austin Texas 78731 United States

Texas Oncology - Methodist Dallas Cancer Center

Dallas Texas 75203 United States

Texas Oncology, P.A. - Fort Worth

Fort Worth Texas 76104 United States

Texas Oncology - Memorial City

Houston Texas 77024 United States

Texas Oncology-Tyler

Irving Texas 75063 United States

Virginia Cancer Specialists - Alexandria

Alexandria Virginia 22304 United States

Virginia Oncology Associates

Norfolk Virginia 23502 United States

Eastern Health; Cancer Services

Box Hill New South Wales 3128 Australia

Concord Repatriation General Hospital; Concord Cancer Centre

Concord New South Wales 2139 Australia

Macquarie University Hospital

Sydney New South Wales 2109 Australia

Royal Brisbane & Women's Hosp; Cancer Care Serv

Herston Queensland 4029 Australia

Adelaide Cancer Centre

Kurralta Park South Australia 5037 Australia

Monash Medical Centre; Oncology

Clayton Victoria 3168 Australia

St Vincents Hospital

Melbourne Victoria 3065 Australia

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

Graz 8036 Austria

Ordensklinikum Linz Barmherzige Schwestern ; Urologie

Linz 4010 Austria

Medizinische Universität Wien; Universitätsklinik für Urologie

Wien 1090 Austria

Onze Lieve Vrouwziekenhuis Aalst

Aalst 9300 Belgium

UZ Gent

Gent 9000 Belgium

CHU Sart-Tilman

Liège 4000 Belgium

Tom Baker Cancer Centre-Calgary

Calgary Alberta T2N 4N2 Canada

Kingston General Hospital

Kingston Ontario K7L 2V6 Canada

Lakeridge Health Oshawa; Oncology

Oshawa Ontario L1G 2B9 Canada

Sunnybrook Research Institute

Toronto Ontario M4N 3M5 Canada

Princess Margaret Cancer Center

Toronto Ontario M5G 1Z6 Canada

Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

Greenfield Park Quebec J4V 2H1 Canada

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal Quebec H3T 1E2 Canada

CHU de Québec - Université Laval - Hôtel-Dieu de Québec

Québec Quebec G1R 2J6 Canada

CHUS (Centre Hospitalier Universitaire de Sherbrooke)

Sherbrooke Quebec J1H 5N4 Canada

Peking University First Hospital

Beijing 100034 China

Friendship Hospital, Capital Medical University

Beijing 100050 China

Beijing Hospital of Ministry of Health

Beijing 100730 China

Chongqing Cancer Hospital

Chongqing 400030 China

Sun Yat-sen Memorial Hospital

Guangzhou 510000 China

Jiangsu Cancer Hospital

Nanjing 210009 China

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing 210029 China

Fudan University Shanghai Cancer Center

Shanghai 200032 China

Zhongshan Hospital Fudan University

Shanghai 200032 China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai 200127 China

The 2nd Hospital of Tianjin Medical University

Tianjin 201203 China

Masarykuv onkologicky ustav

Brno 656 53 Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno 656 91 Czechia

Urocentrum Praha s.r.o.

Praha 2 120 00 Czechia

Thomayerova nemocnice

Praha 4 - Krc 140 59 Czechia

Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

Aalborg 9000 Denmark

Aarhus Universitetshospital; Kræftafdelingen

Aarhus N 8200 Denmark

Herlev Hospital; Onkologisk afdeling

Herlev 2730 Denmark

Odense Universitetshospital, Onkologisk Afdeling R

Odense C 5000 Denmark

Institut de Cancerologie de l Ouest

Angers France

Institut Sainte-Catherine; Oncologie

Avignon 84082 France

CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

Bordeaux 33075 France

Centre Francois Baclesse; Oncologie

Caen 14076 France

Hopital Louis Pasteur; Medecine B

Colmar 68024 France

Centre Oscar Lambret; Chir Cancerologie General

Lille 59000 France

Clinique Chenieux; Oncology

Limoges 87039 France

Centre Leon Berard; Departement Oncologie Medicale

Lyon 69373 France

Hopital Saint Louis, Service D Oncologie Medicale

Paris 75475 France

Hopital d'Instruction des Armees de Begin

Saint-Mande 94160 France

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse 31059 France

Institut Gustave Roussy

Villejuif 94805 France

Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

Berlin 12200 Germany

Städtisches Klinikum Braunschweig gGmbH, Klinik für Urologie und Uroonkologie

Braunschweig 38126 Germany

Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

Dresden 01307 Germany

Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

Freiburg 79106 Germany

Martini-Klinik am UKE GmbH

Hamburg 20246 Germany

Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

Hannover 30625 Germany

Universitätsklinikum Heidelberg, Chirurgische Klinik, Klinik für Urologie

Heidelberg 69120 Germany

Uniklinik Köln, Klinik für Urologie, Uro-Onkologie und spezielle urologische Chirurgie

Köln 50937 Germany

Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie

Magdeburg 39120 Germany

Klinik der Philipps-Universität; Urologie und Kinderurologie

Marburg 35043 Germany

Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

München 81675 Germany

Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

Münster 48149 Germany

Klinikum Nürnberg 5. Medizinische Klinik Hämatologie/Onkologie Universitätsklinik der Paracelsus

Nürnberg 90419 Germany

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen 72076 Germany

Urologisches Zentrum Euregio; Urologische Praxis am Wasserturm

Würselen 52146 Germany

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens 115 22 Greece

Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

Athens 115 28 Greece

Athens Medical Center; Dept. of Oncology

Athens 151 25 Greece

IASO General Hospital of Athens

Athens 155 62 Greece

Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

Kifisia 145 64 Greece

University Hospital of Patras Medical Oncology

Patras 265 04 Greece

Papageorgiou General Hospital; Medical Oncology

Thessaloniki 546 29 Greece

Semmelwies University of Medicine; Urology Dept.

Budapest 1082 Hungary

Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

Budapest 1122 Hungary

Uzsoki Utcai Korhaz

Budapest 1145 Hungary

Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

Debrecen H4032 Hungary

ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

Napoli Campania 80131 Italy

I.R.S.T Srl IRCCS; Oncologia Medica

Meldola Emilia-Romagna 47014 Italy

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena Emilia-Romagna 41100 Italy

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Roma Lazio 00152 Italy

IRCCS AOU San Martino - IST; Oncologia Medica 1

Genova Liguria 16132 Italy

A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

Cremona Lombardia 26100 Italy

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milano Lombardia 20133 Italy

Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

Milano Lombardia 20141 Italy

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari Puglia 70124 Italy

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo Puglia 71013 Italy

Ospedale Area Aretina Nord; U.O.C. Oncologia

Arezzo Toscana 52100 Italy

Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica

Trento Trentino-Alto Adige 38122 Italy

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

Padova Veneto 35128 Italy

Nagoya City University Hospital

Aichi 467-8602 Japan

National Cancer Center East

Chiba 277-8577 Japan

Toho University Sakura Medical Center

Chiba 285-8741 Japan

Kyushu University Hospital

Fukuoka 812-8582 Japan

National Hospital Organization Hokkaido Cancer Center

Hokkaido 003-0804 Japan

Yokohama City University Medical Center

Kanagawa 232-0024 Japan

Kitasato University Hospital

Kanagawa 252-0375 Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto 602-8566 Japan

Nara Medical University Hospital

Nara 634-8522 Japan

Niigata University Medical & Dental Hospital

Niigata 951-8520 Japan

Kansai Medical University Hospital

Osaka 573-1191 Japan

Toranomon Hospital

Tokyo 105-8470 Japan

The Jikei University Hospital

Tokyo 105-8471 Japan

Nippon Medical School Hospital

Tokyo 113-8603 Japan

National Cancer Center

Gyeonggi-do 10408 Korea, Republic of

Seoul National University Hospital

Seoul 03080 Korea, Republic of

Asan Medical Center

Seoul 05505 Korea, Republic of

Samsung Medical Center

Seoul 06351 Korea, Republic of

Medical University of Bialystok; Oncology clinic

Bialystok 15-027 Poland

Przychodnia Lekarska KOMED

Konin 62-500 Poland

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Krakow 31-531 Poland

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

Opole 45-060 Poland

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

Otwock 05-400 Poland

Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.

Warszawa 02-616 Poland

Wojewodzki Szpital; Specjalistyczny ul.

Wroclaw 51-124 Poland

Woj. Wielospecjalistyczne Centrum Onkologii i Traumatologii; Pododdzial Chemioter. Jednego Dnia

Łódź 93-513 Poland

SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

Sankt-peterburg Leningrad 197022 Russian Federation

Blokhin Cancer Research Center; Urological Dept

Moscow 115478 Russian Federation

Russian Scientific Center of Roentgenoradiology

Moscow 117997 Russian Federation

P.A. Herzen Oncological Inst. ; Oncology

Moscow 125284 Russian Federation

Institut Catala d´Oncologia Hospital Germans Trias i Pujol

Badalona Barcelona 08916 Spain

Insititut Catala D'Oncologia

Hospitalet de Llobregat Barcelona 08908 Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell Barcelona 08208 Spain

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba Cordoba 14004 Spain

Hospital Universitario Son Espases; Servicio de Oncologia

Palma De Mallorca Islas Baleares 07014 Spain

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona Navarra 31008 Spain

Hospital Universitari Vall d'Hebron; Oncology

Barcelona 08035 Spain

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona 08036 Spain

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona 08041 Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid 28034 Spain

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid 28040 Spain

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid 28041 Spain

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Malaga 29010 Spain

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla 41013 Spain

Inselspital Bern; Medizinische Onkologie

Bern 3010 Switzerland

Kantonsspital St. Gallen; Onkologie/Hämatologie

St. Gallen 9007 Switzerland

Taichung Veterans General Hospital; Division of Urology

Taichung 407 Taiwan

National Taiwan University Hospital, Department of Urology

Taipei 10048 Taiwan

TAIPEI VETERANS GENERAL HOSPITAL, Urology

Taipei 11217 Taiwan

Chang Gung Memorial Hospital-LinKou; Urology

Taoyuan 333 Taiwan

Queen Elizabeth Hospital

Birmingham B15 2TH United Kingdom

Royal Blackburn Hospital

Blackburn BB2 3HH United Kingdom

BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

Bristol BS2 8HW United Kingdom

Leicester Royal Infirmary

Leicester LE1 5WW United Kingdom

Barts and the London NHS Trust.

London EC1A 7BE United Kingdom

Sarah Cannon Research Institute

London W1G 6AD United Kingdom

The Christie NHS Foundation Trust

Manchester M20 4BX United Kingdom

Royal Marsden Hospital; Institute of Cancer Research

Sutton SM2 5PT United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03016312)

{{footer-clinical-trials-navigation}} Published August 1, 2017

A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy (/clinical-trials/prostate-cancer/96970-a-pilot-presurgical-study-ofdaratumumab-cd38-antagonist-in-men-with-high-risk-localized-prostatecancer-followed-by-radical-prostatectomy.html) {{header-clinical-trials-navigation}}

A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy Condition: Malignant Neoplasms of Male Genital Organs, Prostate Cancer, Adenocarcinoma of the Prostate Intervention: Drug: Daratumumab

Procedure: Prostatectomy Purpose: The goal of this clinical research study is to learn about the safety and tolerability of giving Darzalex (daratumumab) to patients who have prostate cancer before having an already-scheduled prostatectomy (surgical removal of the prostate). Researchers also want to learn if daratumumab can help to control the disease before the prostatectomy. This is an investigational study. Daratumumab is FDA approved and commercially available to treat multiple myeloma. It is considered investigational to use daratumumab in patients with prostate cancer. The study doctor can explain how the study drug is designed to work. Up to 15 participants will be enrolled in this study. All will take part at MD Anderson. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT03177460 Sponsor: M.D. Anderson Cancer Center Primary Outcome Measures: Measure: Adverse Events of Therapy with Daratumumab in Men with High-Risk Localized Prostate Cancer

Time Frame: 90 days following the last dose of study drug

Safety Issue: Secondary Outcome Measures: Measure: Pathological Complete Response (CR) with Daratumumab in Men with High-Risk Localized Prostate Cancer

Time Frame: 6 weeks after study drug stopped

Safety Issue:

Measure: Immunological Changes in Tumor Tissues in Response to Daratumumab in Men with High-Risk Localized Prostate Cancer

Time Frame: 18 weeks

Safety Issue:

Measure: Immunological Changes in Peripheral Blood in Response to Daratumumab in Men with High-Risk Localized Prostate Cancer

Time Frame: 18 weeks

Safety Issue: Estimated Enrollment: 15 Study Start Date: June 7, 2017 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: 1. Consent to MD Anderson laboratory protocol PA13-02

2. Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.

3. Patients with high-risk prostate cancer (at least 1 core with Gleason sum >/=8) must have at least three core biopsies involved with cancer (a minimum of 6 core biopsies, must be obtained at baseline). A prostate biopsy within 3 months from screening is allowed for entry requirements.

4. No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans.

5. Eugonadal state (serum testosterone >150 ng/dL).

6. Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection

7. No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy.

8. Subject must be >/=18 years of age.

9. To avoid risk of drug exposure through the ejaculate (even men with vasectomies),subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug.

10. ECOG performance status (PS) grade of 0 or

11. Clinical laboratory values at screening: 1) Hemoglobin, platelet count, absolute neutrophil count, absolute lymphocyte count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility 2) Serum chemistries, renal and liver panels within institutional normal limits or meets the requirements for radical prostatectomy

12. Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. Exclusion Criteria: 1. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH agonists/antagonists.

2. Currently enrolled in another interventional study.

3. Concurrent treatment with systemic corticosteroids (prednisone dose >10 mg per day or equivalent) or other immunosuppressive drugs <14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.

4. History of or known or suspected autoimmune disease (exception(s): subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed).

5. Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection.

6. History of clinically significant cardiovascular disease including, but not limited to: 1) Myocardial infarction or unstable angina

7. History of major implant(s) or device(s), including but not limited to: 1) Prosthetic heart valve(s) 2) Artificial joints and prosthetics placed

8. Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission)

9. Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study. Contact: Sumit K. Subudhi, MD, PHD

[email protected]

713-563-1602 Location: University of Texas MD Anderson Cancer Center

Houston Texas 77030 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03177460)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer (/clinical-trials/prostate-cancer/96939-a-pilot-study-ofgeriatric-specific-interventions-for-quality-of-life-in-elderly-patients-withcancer.html) {{header-clinical-trials-navigation}}

A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer Condition: Breast Cancer, Prostate Cancer, Lung Cancer, Lymphoma Cancer, Gynecological Cancers Intervention: Behavioral: group intervention and questionnaires

Behavioral: individual phone intervention and questionnaires

Behavioral: expressive writing (arm will not be include in the randomization) Purpose: The purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. This geriatric-specific psychoeducation is intended to help older cancer patients cope with the burden of cancer and aging. The purpose of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety, perception of loneliness and isolation. In addition this counseling aims to improve coping and quality of life (QOL). Individuals who choose not to take part in the intervention study will be asked if they are willing to participate in a brief refusal sub study. The purpose of the refusal substudy is to compare levels of distress in patients that choose to participate and those that decline. This will yield valuable data that will help us distinguish between patients that decline due to lack of interest in research and those that decline due to high levels of distress. Participation in the refusal sub study consists of completion of 2 brief questionnaires. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT00984321 Sponsor: Memorial Sloan Kettering Cancer Center Primary Outcome Measures: Measure: To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence.

Time Frame: 2 years

Safety Issue: Secondary Outcome Measures: Measure: To examine the impact of these GSPI in both formats on depressive symptoms, anxiety, demoralization, coping, loneliness and isolation, and spirituality compared to the control group.

Time Frame: 2 years

Safety Issue: Estimated Enrollment: 126 Study Start Date: September 2009 Eligibility: Age: minimum 70 Years maximum N/A

Gender: All Inclusion Criteria: Have a diagnosis of prostate, breast cancer lung, lymphoma, or gynecological.

Are receiving active treatment (e.g., radiation, hormone, or chemotherapy)or have been receiving treatment in the past 6 months for prostate, breast, lung, lymphoma, or gynecological cancer

Are 70 years old or older

Greater than 6-months post diagnosis

Have a Distress Thermometer score of 4 or greater or a score of ≥ 6 on the Depression or Anxiety subscale of the HADS

Have a Karnofsky Performance Rating of 60 or greater

In the investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in Geriatric Specific Psychoeducational Intervention. The Blessed Orientation-Memory-Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.

Able to converse, write and read in English. The questionnaires were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require a very lengthy process of reestablishing the reliability and validity and the establishment of norms for these measures. Therefore, participants must be able to communicate in English to complete the questionnaires. Exclusion Criteria: Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment).

As per self-report or review of the patient's medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication.

Actively participating in protocol 07-094 or 11-021 Contact: Andrew Roth, MD

646-888-0024 Locations: Memorial Sloan Kettering Cancer Center

New York New York 10065 United States

Joan Karnell Cancer Center at Pennsylvania

Philadelphia Pennsylvania 19106 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00984321)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch (/clinical-trials/prostate-cancer/94518-a-pilot-study-of-high-dose-ratebrachytherapy-in-the-radiation-oncology-branch.html) {{header-clinical-trials-navigation}}

A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch Condition: Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer, Biliary Cancer Intervention: Radiation: Brachytherapy Purpose: Background: - One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. - Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: - To evaluate the quality of the brachytherapy procedure at the National Institutes of Health s Radiation Oncology Branch. Eligibility: - Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: - In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. - Each treatment will take place in the Radiation Oncology Clinic. - If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. - The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. - The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. - Patients will return to the Radiation Oncology Clinic for followup visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Followup evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, MRI, X-ray) that was done at baseline to evaluate the tumor response. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT00924027 Sponsor: National Cancer Institute (NCI) Primary Outcome Measures: Measure: To determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch.

Time Frame: Completion of treatment

Safety Issue: Secondary Outcome Measures: Measure: To evaluate local control and late toxicity rates following brachytherapy at NCI ROB.

Time Frame: Completion of study

Safety Issue:

Measure: To increase the flow of oncology patients requiring brachytherapy to the NCI ROB.

Time Frame: Completion of study

Safety Issue: Estimated Enrollment: 112 Study Start Date: March 17, 2009 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum 90 Years

Gender: All Inclusion Criteria: 1. Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen. 2. Age greater than 18 years of age. 3. ECOG performance status of 0, 1, or 2. 4. Patient must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient. 5. Patients of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. 6. Sitespecific inclusion criteria (any one or more of the following): Gynecologic Cancers: Endometrial cancer

Patients at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging)

Patients who have suffered a recurrence at the vaginal cuff

Patients who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer. Cervical cancer

Patients who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer.

Patients with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting). Lung cancer

Patients with an endobronchial component causing symptoms

Patients who can not undergo resection because of poor lung function or distant lung metastasis Breast cancer

Infiltrating ductal carcinoma or DCIS, stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0,

Patients benefiting from HDR as either as a boost or accelerated partial breast irradiation regimen. Prostate Cancer Patients with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management. Exclusion Criteria: 1. Cognitively impaired patients who cannot give informed consent and do not have a legal guardian. 2. Patients currently receiving concurrent investigational chemotherapeutic agents. 3. Patients receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen) 4. Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn. 5. Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to tolerate this therapy or are likely to interfere with the study procedures or results. 6. Patients who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment. 7. Abnormal bleeding times or active anti-coagulation therapy.

platelets less than 100,000 per mm(3)

PT/PTT greater than 1.5 the upper normal limit (UNL) 8. Any patient or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per ABS guidelines. 9. Patients whose malignancy has one or more of the following site-specific criteria disqualifying them from the study: 1. Breast cancer:

Patients inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins);

male patients with breast cancer

autoimmune disorders, including SLE, Scleroderma, etc

distant metastases; 2. Prostate cancer:

distant metastases Contact: Theresa Cooley-Zgela, R.N.

[email protected]

(240) 760-6207 Location: National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda Maryland 20892 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00924027)

{{footer-clinical-trials-navigation}} Published March 5, 2017

A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer (/clinicaltrials/prostate-cancer/93286-a-pilot-study-of-magnetic-resonance-mrimaging-with-hyperpolarized-pyruvate-13c-to-detect-high-grade-localizedprostate-cancer.html) {{header-clinical-trials-navigation}}

A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer Condition: Prostate Cancer Intervention: Drug: Pyruvate (13C) Purpose: This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02526368 Sponsor: University of California, San Francisco Primary Outcome Measures: Measure: Difference in peak lactate/pyruvate conversion with histologic grade of prostate cancer

Time Frame: Baseline

Safety Issue: Secondary Outcome Measures: Measure: Safety As measured by Adverse Events

Time Frame: Up to 2 years

Safety Issue:

Measure: Optimal cut-off value of lactate/pyruvate that accurately detects primary Gleason 4 component cancer.

Time Frame: Baseline

Safety Issue: Estimated Enrollment: 50 Study Start Date: November 2015 Phase: Early Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of UCSF, if detailed results of sextant biopsy are available. A minimum of 20 patients out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.

Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.

The subject is able and willing to comply with study procedures and provide signed and dated informed consent.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/µL, hemoglobin ≥9.0 gm/dL, platelets ≥75,000 cells/µL, estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation), bilirubin <1.5x ULN (unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5x ULN.

For patients with partners of childbearing potential, willing to use adequate contraception for one month after undergoing HP pyruvate infusion. Exclusion Criteria: Patients who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.

Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.

Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy.

Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.

Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.

Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. No limit on number of prior prostate biopsies. Prior TURP is not allowed.

Current or prior androgen deprivation therapy. A history of use of a 5- reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry.

Poorly controlled hypertension, with blood pressure at study entry >160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.

Congestive heart failure or New York Heart Association (NYHA) status ≥ 2.

A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter will be allowed on study. Contact: Rahul Aggarwal, MD

[email protected]

(415) 353-9278 Location: University of California, San Francisco

San Francisco California 94158 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02526368)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer (/clinical-trials/prostatecancer/93305-a-pilot-study-to-evaluate-the-reproducibility-of-magneticresonance-mr-imaging-with-hyperpolarized-pyruvate-13c-and-its-ability-toreflect-treatment-effects-in-patients-with-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer Condition: Prostate Cancer Intervention: Drug: Pyruvate Purpose: This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT. 13C HP MR data will be acquired in two parts of the study (which can occur simultaneously): Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks later (with no intervention in the interim) to evaluate reproducibility. Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment. The change in pyruvate/lactate ratio and lactate levels will be measured and compared to baseline at these timepoints. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02450201 Sponsor: University of California, San Francisco Primary Outcome Measures: Measure: Difference in peak lactate/pyruvate ratio

Time Frame: Baseline and 2-3 weeks after 1st image

Safety Issue:

Measure: Difference in peak lactate/pyruvate ratio

Time Frame: Baseline and 2 months after 1st image

Safety Issue: Secondary Outcome Measures: Measure: Pyruvate area under the curve (AUC)

Time Frame: Baseline and 2-3 weeks after 1st image

Safety Issue:

Measure: Lactate area under the curve (AUC)

Time Frame: Baseline and 2-3 weeks after 1st image

Safety Issue:

Measure: Pyruvate area under the curve (AUC)

Time Frame: Baseline and 2 months after 1st image

Safety Issue:

Measure: Lactate area under the curve (AUC)

Time Frame: Baseline and 2 months after 1st image

Safety Issue:

Measure: Safety As measured by Adverse Events

Time Frame: Up to 2 years

Safety Issue: Estimated Enrollment: 10 Study Start Date: June 2015 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by UCSF CAPRA scoring and possesses a Gleason 4 component to the tumor. Subjects will be enrolled either prior to radical prostatectomy (N=5) or prior to 2 months of androgen deprivation therapy (LHRH agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=5).

The subject is able and willing to comply with study procedures and provide signed and dated informed consent.

At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm).

The subject has concordant MRI/1H MRSI findings from a MR staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Laboratory criteria for protocol entry:

Absolute neutrophil count (ANC) ≥1000 cells/µL

Hemoglobin ≥9.0 gm/dL

Platelets ≥75,000 cells/µL

Estimated creatinine clearance ≥50 mL/min

Total bilirubin ≤1.5x ULN (or if ≤4 gm/dL and direct bilirubin is WNL)

Aspartate aminotransferase (AST) ≤1.5x ULN

Alanine aminotransferase (ALT) ≤1.5x ULN

Willing to use contraception during and for 1 month after completion of the study.

For part 2 of the study: plans to initiate castrating therapy (with a GnRH antagonist, GnRH agonist, or orchiectomy). An antiandrogen may be started after initial imaging but can not be used prior to baseline imaging. An antiandrogen is allowed but not required. Exclusion Criteria: The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.

Current or prior androgen deprivation therapy; previous use of a 5- reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry.

Poorly controlled hypertension, with blood pressure at study entry>160/100.

Contraindication for or inability to tolerate MRI examination.

Prostate biopsy within 12 weeks prior to study entry.

BMI of less than 18.5 or greater than 32. Subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available.

Congestive heart failure or New York Heart Association (NYHA) status≥2.

A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.

Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year. Contact: Rahul Aggarwal, MD

[email protected]

415-353-9278 Location: University of California, San Francisco

San Francisco California 94158 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02450201)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Pred (/clinical-trials/prostatecancer/93289-a-prospective-single-arm-phase-i-ii-study-using-11c-cholinepet-scans-for-dose-escalated-hypofractionated-image-guided-inverselyplanned-intensity-modulated-external-beam-radiotherapy-with-boost-to-petdefined-dominant-intraprostatic-lesions-and-as-a-pred.html) {{header-clinical-trials-navigation}}

A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Predictive Factor for Biochemical Disease-Free Survival in Patients With Localized Prostate Cancer Condition: Prostatic Neoplasms Intervention: Radiation: 11C-Choline Purpose: Patients with localized prostate cancer are routinely treated with radiation therapy to the entire prostate gland. The investigators can identify where the cancer is concentrated in the prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for choline positron emission tomography). This is different from the older type of PET scan that has been used in the past (called FDG PET) which has not been as accurate as the new PET scan for identifying where the cancer is in the prostate gland. It has also been shown that delivering higher doses of radiation to prostate cancer cells in the prostate have resulted in better cure rates in patients with prostate cancer. Therefore for goal number one the investigators want to give higher radiation dose to the prostate cancer cells. But the challenge has been that delivering higher doses of radiation to the prostate gland may also increase the chance of complications from the higher doses of radiation to the rectum, bladder and surrounding area. Therefore for goal number two the investigators want to minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla Magnetic Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to identify the urethra in the prostate so that the investigators can minimize the radiation dose to the urethra. The investigators believe the 3T MRI scan is able to point to the areas of cancer that may be able to predict how well the treatments may work, as well as which areas of the tumor appear to be responding to failing. In this study, the investigators will keep the dose of radiation to the rectum and bladder as low as possible while increasing radiation dose to parts of the prostate with more cancer cells. The investigators will compare the cure rates in this study with the cure rates of other patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland. The investigators will also compare the rates of complications in this study with the rates of complications in patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02004418 Sponsor: AHS Cancer Control Alberta Primary Outcome Measures: Measure: Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT.

Time Frame: After 3 months

Safety Issue:

Measure: Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT

Time Frame: After 3 years

Safety Issue:

Measure: Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT

Time Frame: After 5 years

Safety Issue: Secondary Outcome Measures: Measure: Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT

Time Frame: 3 months

Safety Issue:

Measure: Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT

Time Frame: 6 months

Safety Issue: Estimated Enrollment: 63 Study Start Date: March 2014 Phase: Phase 1/Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: 1. Age ≥ 18 years

2. Biopsy proven prostate cancer with an intermediate risk feature defined as

3. Gleason score 7, PSA <20, T1-T2C or

4. Gleason score 6, PSA 10-20, T1-T2C or

5. Gleason Score 6 or 7, PSA <20, T2C

6. Localized disease based on staging investigations including bone scan, CT abdomen and pelvis, and any other clinically indicated staging investigations

7. Eligible for curative intent external beam radiotherapy

8. Able and willing to follow instructions and comply with protocol

9. Provide written informed consent prior to participation in the study

10. Karnofsky Performance Scale Score 70-100 Exclusion Criteria: 1. Have had a 11C-Choline PET scan performed within 4 weeks after any biopsies of the prostate (due to concern that acute post biopsy intraprostatic changes may affect scan accuracy)

2. BMI ≥ 30

3. The presence of a hip prosthesis

4. Bilirubin ≥ 20 µmol/L

5. AST or ALT ≥ 5 times the upper limits of normal

6. Serious medical conditions which may prevent a patient from tolerating therapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections and/or uncontrolled diabetes.

7. Metastatic disease

8. Prostate cancer with only low risk features or any high risk feature with a PSA ≥20 or T3 disease

9. A history of previous carcinoma except for basal cell carcinoma

10. Age < 18 years

11. Prior treatment with hormonal therapy

12. AUA prostate symptom score > 20

13. Crohn's disease or ulcerative colitis

14. Patient is unable to comply adequately iwth bowel or bladder prep during CT simulation Contact: John Amanie, MD

780-432-8518 Location: Cross Cancer Institute

Edmonton Alberta T6G 1Z2 Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02004418)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Prospective Stage 2S Clinical Trial Evaluating Hemi-Ablative Low Dose Rate (LDR) Brachytherapy for Localised Prostate Cancer (/clinicaltrials/prostate-cancer/93332-a-prospective-stage-2s-clinical-trial-evaluatinghemi-ablative-low-dose-rate-ldr-brachytherapy-for-localised-prostatecancer.html) {{header-clinical-trials-navigation}}

A Prospective Stage 2S Clinical Trial Evaluating Hemi-Ablative Low Dose Rate (LDR) Brachytherapy for Localised Prostate Cancer Condition: Prostatic Neoplasms, Cancer of the Prostate Intervention: Radiation: Hemi gland focal LDR brachytherapy Purpose: This clinical study will evaluate side effects, quality of life and cancer control in patients with prostate cancer diagnosed on only one side of the prostate gland. The diagnosis of unilateral prostate cancer will be made by means of a prostate transperineal template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI). Patients will be treated with low dose rate brachytherapy, using permanent iodine seed implants.Treatment will be limited to the side of the gland where the cancer has been diagnosed and is therefore called "focal" brachytherapy. Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal approach, the side effects will be evaluated by means of patient questionnaires.These will be repeated at various intervals after treatment.The results will be compared to the same questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore an assessment can be made whether focal therapy produces fewer side effects than whole gland brachytherapy.The observation period will last for two years after treatment. A biopsy and mpMRI will be repeated after two years to evaluate prostate cancer control. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02632669 Sponsor: Royal Surrey County Hospital NHS Foundation Trust Primary Outcome Measures: Measure: Treatment related Urinary toxicity (symptoms) as recorded by the IPSS questionnaire score.

Time Frame: 2 years

Safety Issue:

Measure: Treatment related Quality of Life (QoL) due to urinary symptoms as recorded by the Quality of Life (QoL) component of the IPSS questionnaire score.

Time Frame: 2 years

Safety Issue:

Measure: Treatment related bowel toxicity (symptoms) as recorded by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) questionnaire (30 PR 25) score.

Time Frame: 2 years

Safety Issue:

Measure: Treatment related adverse events on Erectile function as recorded by the International Index of Erectile Function 5 (IIEF 5) questionnaire score.

Time Frame: 2 years

Safety Issue: Secondary Outcome Measures: Measure: To evaluate tumor control of hemigland focal brachytherapy

Time Frame: 2 years

Safety Issue: Estimated Enrollment: 34 Study Start Date: November 2013 Eligibility: Age: minimum N/A maximum N/A

Gender: Male Inclusion Criteria: 1. TRUS biopsy (if taken): unilateral disease only

2. Template biopsy (TTB): unilateral disease only, AND Gleason < 7 (either 3+4 or 4+3)

3. mp-MRI results: Disease must present as unilateral (left or right) only

4. Stage T1-T2bN0M0 disease, as determined by local guidelines *

5. Serum PSA < 15

6. Prostate volume < 50cc

7. Eligible for brachytherapy as outlined in local guidelines*

8. Life expectancy > 10 years Exclusion Criteria: 1. Men who have had previous radiation therapy 2. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer 3. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.

https://www.rcr.ac.uk/quality-assurance-practice-guidelines-transperineal-ldr-per manent-seed-brachytherapy-prostatecancer Contact: Ceri Jamieson

[email protected]

44(0)1483406612 Location: Royal Surrey NHS Foundation Trust

Guildford GU2 7XX United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02632669)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients (/clinical-trials/prostate-cancer/96919-a-prospective-study-assessing-thepredictive-value-of-tmprss2-erg-gene-fusion-and-pten-deletion-in-high-riskprostate-cancer-patients.html) {{header-clinical-trials-navigation}}

A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients Condition: Prostate Cancer Purpose: One of the biggest problems facing prostate cancer patients and their treating physicians is who needs to be treated and when. Common clinical and pathological parameters are useful (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and who will fail. Genetic markers for tumor aggressivity would be of greater value. The finding that the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family of proteins which have a role in controlling cell growth, cell specialization and producing tumors. As a consequence of this gene fusion, production of the ERG protein increases in the presence of testosterone and could be key to the development of prostate cancer, resistance to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor. Its deletion is a contributing factor in the development of prostate cancers and poor outcome. The coexistence of the two markers could be associated with a higher risk of recurrence. To date there have been no studies regarding the presence of either of these two markers or their coexistence in high risk prostate cancer patients who, despite radiation therapy and androgen suppression, develop biochemical failure (their PSA levels rise once again). Patients participating in the PCS IV study (high risk prostate cancer treated with radiation therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical failure or 3 years of follow-up post hormonal therapy will be approached. Tumor blocks from consenting patients will be collected and analyzed for the presence of the TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish General Hospital. Statistical analysis will be carried out to see whether either or both markers are present, whether they are associated with certain clinical and pathological high risk factors, and whether they can be used to predict which patients will fail treatment. Study Type: Observational Clinical Trials Identifier NCT 8-digits: NCT01350180 Sponsor: Dr. Tamim Niazi Primary Outcome Measures: Measure: number of patients with biochemical failure showing the TMPRSS2-ERG gene fusion and/or PTEN deletion

Time Frame: recruitment over 2 years

Safety Issue: Estimated Enrollment: 132 Study Start Date: September 2010 Eligibility: Age: minimum N/A maximum N/A

Gender: Male Inclusion Criteria: patients with prostate cancer post radical radiation therapy and LHRH agonist treated in PCSIV clinical trial

biochemical failure (PSA nadir + 2) or minimum follow-up of 3 years post completion of hormonal therapy

high risk group 1. gleason score 8-10 2. PSA ≥ 20 ng/ml 3. T3 or T4 Contact: Sarah Riggio

[email protected]

514-340-8222 Ext. 26771 Locations: Hôpital de Gatineau

Gatineau Quebec Canada

CHUM-Notre- Dame

Montreal Quebec Canada

Hôpital Maisonneuve-Rosemont

Montreal Quebec Canada

Jewish General Hospital

Montreal Quebec Canada

Montreal General Hospital

Montreal Quebec Canada

CHUS - Hôpital Fleurimont - Sherbrooke

Sherbrooke Quebec Canada

Centre Hospitalier régional de Trois-Rivières

Trois-Rivières Quebec Canada

CHUQ, L'Hôtel-Dieu de Québec

Quebec Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01350180)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy With EBRT in Intermediate and High Risk Localised Prostate CAncer Patients and Its Effects on Toxicity and Quality of Life (/clinicaltrials/prostate-cancer/93568-a-randomised-feasibility-trial-to-investigate-thetiming-of-hdr-brachytherapy-with-ebrt-in-intermediate-and-high-risk-localisedprostate-cancer-patients-and-its-effects-on-toxicity-and-quality-of-life.html) {{header-clinical-trials-navigation}}

A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy With EBRT in Intermediate and High Risk Localised Prostate CAncer Patients and Its Effects on Toxicity and Quality of Life Condition: Prostate Cancer Intervention: Radiation: Timing of HDR Brachytherapy to EBRT Purpose: TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility trial. SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014 Study Duration Recruitment Duration 18-24 months Study Centre Southend University Hospital NHS Foundation Trust Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual dysfunction at various time points. Number of Participants 50 participants Main Inclusion Criteria - Patient age >18 years - Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 - Any Gleason score - Any PSA level - Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous TURP/HoLEP Laser Prostatectomy - Any Metastatic Disease - IPSS>20 - Pubic arch interference - Lithotomy position or anaesthesia not possible - Rectal fistula - Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse events will be compared using Fisher's Exact Test. Toxicity score means will be compared using two-sample permutation t-tests, and PSA relapse-free survival will be estimated using Kaplan-Meier and compared using log-rank tests. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02618161 Sponsor: Southend University Hospital Foundation NHS Trust Primary Outcome Measures: Measure: Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT

Time Frame: 12 months

Safety Issue: Secondary Outcome Measures: Measure: Biochemical response and survival

Time Frame: 12 months

Safety Issue:

Measure: Gastrointestinal toxicities according to the treatment sequence of HDR Brachytherapy and EBRT

Time Frame: 12 months

Safety Issue:

Measure: Radiotherapy Planning Challenges including Image Guided Radiotherapy

Time Frame: 12 months

Safety Issue: Estimated Enrollment: 52 Study Start Date: September 2014 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Patient age >18 years

Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0

Any Gleason score

Any PSA level

Patient able to consent and fill in the questionnaires Exclusion Criteria: Previous TURP/HoLEP Laser Prostatectomy

Any Metastatic Disease

IPSS>20

Pubic arch interference

Lithotomy position

If Anaesthesia is not possible

Rectal fistula

Prior pelvic radiotherapy Contact: Micheal Harrison

[email protected]

08451964938 Location: Southend University Hospital NHS Foundation trust

Westcliff on sea Essex SS0 0RY United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02618161)

{{footer-clinical-trials-navigation}} Published January 22, 2017

A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA) (/clinicaltrials/prostate-cancer/93306-a-randomized-clinical-trial-comparing-theefficacy-of-mri-versus-psa-for-prostate-cancer-screening-the-mvp-study-mrivs-psa.html) {{header-clinical-trials-navigation}}

A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA) Condition: Prostate Cancer Intervention: Device: Multi-parametric MRI

Other: PSA testing Purpose: In this open randomized controlled trial, we seek to study whether prostate cancer screening using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy) compared with prostate cancer screening using prostate-specific antigen (PSA). The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with subsequent investigations driven by the serum PSA level. This model has proven highly controversial due to the inability of PSA level to discern between indolent and aggressive forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended against PSA screening. Evidence suggests that prostate cancer screening has led to an increased proportion of men being diagnosed with potentially curable prostate cancer. However, due to the inability of the PSA level to accurately distinguish patients with indolent and lethal forms of prostate cancer, it has led to a significant rate of over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an increasingly large role in the management of patients with clinically-localized prostate cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on active surveillance and staging prior to definitive interventions. MRI-based prostate cancer risk assessment has been shown to better distinguish between clinicallysignificant and insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based prostate cancer screening and PSA-based prostate cancer screening is warranted. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02799303 Sponsor: Sunnybrook Health Sciences Centre Primary Outcome Measures: Measure: Clinically-significant prostate cancer

Time Frame: Within 3 years of randomization

Safety Issue: Secondary Outcome Measures: Measure: Clinically-insignificant prostate cancer

Time Frame: Within 3 years of randomizations

Safety Issue: Estimated Enrollment: 1010 Study Start Date: June 2016 Phase: Phase 3 Eligibility: Age: minimum 50 Years maximum N/A

Gender: Male Inclusion Criteria: age greater than or equal to 50 years old

life expectancy greater than or equal to 10 years, according to the clinical judgement of study investigators Exclusion Criteria: history of previous prostate biopsy

PSA level measurement within 3 years of recruitment date

abnormal digital rectal examination of the prostate consistent with prostate cancer

history of prostate cancer in one or more first-degree relatives diagnosed at less than 50 years of age

lower urinary tract voiding symptoms (IPSS greater than or equal to 8)

prior or current use of 5-alpha reductase inhibitor medications (finasteride or dutasteride)

patient unable to communicate in English in order to give proper informed consent

claustrophobia or other medical indication which would preclude MRI

any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives Contact: Robert Nam, MD

[email protected]

416-480-5075 Location: Sunnybrook Health Sciences Centre

Toronto Ontario M4N3M5 Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02799303)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer (/clinicaltrials/prostate-cancer/93313-a-randomized-controlled-trial-of-adv-tkvalacyclovir-administered-during-active-surveillance-for-newly-diagnosedprostate-cancer.html) {{header-clinical-trials-navigation}}

A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer Condition: Prostate Cancer Intervention: Biological: aglatimagene besadenovec

Biological: placebo

Drug: valacyclovir Purpose: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak® or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02768363 Sponsor: Advantagene, Inc. Primary Outcome Measures: Measure: Proactive surveillance score

Time Frame: 12 months

Safety Issue: Secondary Outcome Measures: Measure: Biochemical response (change in PSA)

Time Frame: Assessed at each visit at 3, 6, 9 and 12 months

Safety Issue:

Measure: Patient reported Health Related Quality of Life

Time Frame: Assessed at each visit at 3, 6, 9 and 12 months

Safety Issue:

Measure: Time to radical treatment

Time Frame: 5 years

Safety Issue:

Measure: The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase.

Time Frame: Assessed at each visit at 3, 6, 9 and 12 months

Safety Issue: Estimated Enrollment: 156 Study Start Date: May 2016 Phase: Phase 2/Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: include:

Histologically confirmed adenocarcinoma of the prostate

Patients choosing active surveillance

Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature

NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a

NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c

High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a

Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1

Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.

ECOG Performance status 0-2 Exclusion Criteria: include:

Active liver disease, including known cirrhosis or active hepatitis

Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs

Known HIV+ patients

Regional lymph node involvement or distant metastases

Other current malignancy (except squamous or basal cell skin cancers)

Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up

Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator

Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)

Patients who had or plan to use ADT or have history of an orchiectomy.

Patients who are planning to undergo radical treatment for prostate cancer within 12 months.

Known sensitivity or allergic reactions to acyclovir or valacyclovir Locations: Foothills Urology

Golden Colorado 80401 United States

21st Century Oncology

Fort Lauderdale Florida 33301 United States

Walter Reed National Military Medical Center

Bethesda Maryland 20889 United States

University of Massachusetts Medical School

Worcester Massachusetts 01605 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

Bronx New York 10461 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

Hartsdale New York 10530 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

Hauppauge New York 11749 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

North Hills New York 11042 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

Plainview New York 11803 United States

Associated Medical Professionals of NY, PLLC

Syracuse New York 13210 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

West Nyack New York 10994 United States

Southwest Urology, Clinical Research Solutions

Middleburg Heights Ohio 44130 United States

Oregon Urology Insitute

Springfield Oregon 97477 United States

Lancaster Urology

Lancaster Pennsylvania 17604 United States

Allegheny Health Network-Triangle Urological Group

Pittsburgh Pennsylvania 15212 United States

Ralph H. Johnson Veterans Affairs Medical Center

Charleston South Carolina 29401 United States

Woodland Center

The Woodlands Texas 77384 United States

Texas Urology Specialists

Tomball Texas 77375 United States

Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán

Mexico City Mexico View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02768363)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer (/clinical-trials/prostatecancer/93267-a-randomized-controlled-trial-of-prostatak-as-adjuvant-to-upfront-radiation-therapy-for-localized-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer Condition: Prostate Cancer Intervention: Biological: ProstAtak®(AdV-tk) + valacyclovir

Biological: Placebo + valacyclovir Purpose: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01436968 Sponsor: Advantagene, Inc. Primary Outcome Measures: Measure: Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.

Time Frame: Assessed at each visit every 6 months through year 5 until event occurs.

Safety Issue: Secondary Outcome Measures: Measure: Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.

Time Frame: Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.

Safety Issue:

Measure: PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.

Time Frame: Assessed at each visit every 6 months through year 5.

Safety Issue:

Measure: Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.

Time Frame: Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.

Safety Issue:

Measure: The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion.

Time Frame: Assessed at each visit and continuously throughout the study.

Safety Issue: Estimated Enrollment: 711 Study Start Date: September 2011 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: include:

Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature

NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c

High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a

Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1

Planning to undergo standard prostate-only external beam radiation therapy

ECOG Performance Status 0-2 Exclusion Criteria: include:

Liver disease, including known cirrhosis or active hepatitis

Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs

Known HIV+ patients

Regional lymph node involvement or distant metastases

Patients planning to receive whole pelvic irradiation

Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months

Patients who had or plan to have orchiectomy as the form of hormonal ablation

Known sensitivity or allergic reactions to acyclovir or valacyclovir Locations: Arizona Oncology Services Foundation

Multiple Locations Arizona 85260 United States

Precision Radiation Oncology

Tustin California 92780 United States

Foothills Urology

Golden Colorado 80401 United States

Advanced Urology

Parker Colorado 80134 United States

Sibley Memorial Hospital

Washington District of Columbia 20016 United States

21st Century Oncology

Fort Lauderdale Florida 33324 United States

21st Century Oncology

Lakewood Ranch Florida 34202 United States

21st Century Oncology

Naples Florida 34102 United States

21st Century Oncology

Plantation Florida 33324 United States

The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center

Baltimore Maryland 21231 United States

Walter Reed National Military Medical Center

Bethesda Maryland 20889 United States

University of Massachusetts Medical School

Worcester Massachusetts 01605 United States

New Mexico Oncology Hematology Consultants (NMOHC)

Albuquerque New Mexico 87109 United States

University of New Mexico Cancer Center

Albuquerque New Mexico 87131 United States

Advanced Radiation Centers of New York

Bronx New York 10461 United States

Advanced Radiation Centers of New York

Hartsdale New York 10530 United States

Advanced Radiation Centers of New York

Hauppauge New York 11749 United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

North Hills New York 11042 United States

Advanced Radiation Centers of New York

Plainview New York 11803 United States

Associated Medical Professionals of NY, PLLC

Syracuse New York 13210 United States

Advanced Radiation Centers of New York

West Nyack New York 10994 United States

Southwest Urology, Clinical Research Solutions

Middleburg Heights Ohio 44130 United States

Oregon Urology Institute

Springfield Oregon 97477 United States

Lancaster Urology

Lancaster Pennsylvania 17604 United States

Fox Chase Cancer Center

Philadelphia Pennsylvania 19111-2497 United States

Allegheny General Hospital, Allegheny Health Network

Pittsburgh Pennsylvania 15212 United States

Triangle Urological Group, Allegheny Health Network

Pittsburgh Pennsylvania 15212 United States

Ralph H. Johnson Veterans Affairs Medical Center

Charleston South Carolina 29401 United States

Urology Clinics of North Texas

Dallas Texas 75231 United States

Dr. Irving Fishman's Office

Houston Texas 77030 United States

Houston Willowbrook Radiation Oncology

Houston Texas 77070 United States

Dr. Ned Stein's Office

Houston Texas 77074 United States

Millennium Radiation Center - The Woodlands

The Woodlands Texas 77380 United States

Texas Urology Specialists

Tomball Texas 77375 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01436968)

{{footer-clinical-trials-navigation}} Published January 21, 2018

A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone. (/clinical-trials/prostate-cancer/96146-a-randomized-multicenterphase-iii-trial-comparing-enzalutamide-vs-a-combination-of-ra223-andenzalutamide-in-asymptomatic-or-mildly-symptomatic-castration-resistantprostate-cancer-patients-metastatic-to-bone.html) {{header-clinical-trials-navigation}}

A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone. Condition: Prostate Cancer Intervention: Drug: Ra223

Drug: Enzalutamide Purpose: The objective of this randomized phase III open label trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02194842 Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Primary Outcome Measures: Measure: radiological progression-free survival

Time Frame: 46 months after first patient entry

Safety Issue: Secondary Outcome Measures: Measure: Overall survival

Time Frame: 63 months after first patient entry

Safety Issue:

Measure: prostate cancer specific survival

Time Frame: 63 months after first patient entry

Safety Issue:

Measure: First symptomatic skeletal event

Time Frame: 46 and 63 months after first patient entry

Safety Issue:

Measure: Time and incidence of first skeletal progression-free

Time Frame: 46 and 63 months after first patient entry

Safety Issue:

Measure: Time from entry to initiation of next systemic therapy

Time Frame: 46 and 63 months after first patient entry

Safety Issue:

Measure: Treatments elected after first disease progression

Time Frame: 46 and 63 months after first patient entry

Safety Issue:

Measure: Second progression-free survival in sequential regimen

Time Frame: 46 and 63 months after first patient entry

Safety Issue:

Measure: Pain

Time Frame: 46 and 63 months after first patient entry

Safety Issue:

Measure: Time to pain progression

Time Frame: 63 months after first patient entry

Safety Issue:

Measure: Occurence of adverse events

Time Frame: 63 months after first patient entry

Safety Issue:

Measure: Time to use of opioid analgesics

Time Frame: 63 months after first patient entry

Safety Issue:

Measure: Quality of Life

Time Frame: 46 and 63 months after first patient entry

Safety Issue: Estimated Enrollment: 560 Study Start Date: October 2015 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically confirmed diagnosis of prostate adenocarcinoma: 1. Asymptomatic or mildly symptomatic (defined as no opioids and Brief Pain Inventory score) 2. Metastatic to bone with ≥ 2 bone metastases (area of increase uptake on 99mTC BS (Technetium-99m bone scintigraphy) confirmed by standard X-Ray, Computed tomography (CT), or Magnetic resonance imaging (MRI)) with or without additional lymph node metastases. Visceral metastases are not allowed 3. Progressive Castration-resistant prostate cancer (CRPC) according to Prostate Cancer Working Group 2 (PCWG2) i.e. either of:

For patients who manifest disease progression solely as a rising Prostate-specific antigen (PSA) level. PCWG2 criteria require documentation of a sequence of rising PSA values at a minimum of 1-week intervals with the last value ≥ 2 ng/ml.

For patients with disease progression manifest in the bone, irrespective of progression by rising PSA, PCWG2 guidelines require appearance of 2 or more new lesions. Ambiguous results should be confirmed by other imaging modalities than bone scan and x-ray (e.g.: CT-scan or MRI).

For patients with disease progression manifest at nodal sites, irrespective of progression by rising PSA, PCWG2 requires progression according to RECIST 1.1.

Ongoing androgen deprivation therapy with LHRH (Human luteinizing hormone-releasing hormone) agonist or antagonist or bilateral orchiectomy

Patients must be at least 18 years old

WHO Performance status 0-1

Charlson score ≤ 3

Castrate serum levels of testosterone (< 50 ng/dL)

Biochemistry and hematology: 1. Adequate bone marrow function (absolute neutrophil count 1.5109/L; platelets 100 109/L, and hemoglobin > or = 10.0 g/dl.). 2. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patient with Gilbert's disease 5.0 ULN 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN 4. Creatinine < or= 1.5 x ULN 5. Albumin > 25 g/L

Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG) (complete, standardized 12-lead recording)

Able to swallow the study drug and comply with study requirements

Prior or concomitant therapy 1. Prior docetaxel is permitted under the following conditions: start within 2 months of Androgen deprivation therapy (ADT) initiation, given for a maximum of 6 cycles and progression within 6 months of the last dose of docetaxel. 2. Previous treatment with bicalutamide, flutamide, prednisone, or dexamethasone is allowed if it was stopped at least 4 weeks prior to entry in the study 3. Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4 weeks or more prior to randomization. (These treatments may then be continued on study)

use of adequate birth control measures during the study treatment period and for at least 3 months after last dose of enzalutamide and 6 months after the last dose of Ra223.

Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations Exclusion Criteria: No known history of central nervous system metastases or leptomeningeal tumor spread.

No significant cardiovascular disease including: 1. Myocardial infarction within 6 months prior to screening 2. Uncontrolled angina within 3 months prior to screening 3. Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45% 4. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) 5. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place 6. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening 7. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening 8. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening ECG and on physical examination

patients having received docetaxel for CRPC are excluded.

No prior treatment with enzalutamide or Ra223

No prior and concomitant treatment with Cyp17 inhibitors (abiraterone, orteronel) and ketoconazole

No prior hemibody external radiotherapy. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets

No prior therapy with other radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188)

No involvement in another therapeutic trial involving an experimental drug

No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization

No known hypersensitivity to compounds related to enzalutamide or Ra223

No prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer), or the patient has been free of malignancy for a period of 3 years prior to randomization date

No history of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of enrollment (registration date), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arterio-venous malformation, head trauma with loss of consciousness requiring hospitalization)

No major surgery within 4 weeks prior to treatment

No intake of narcotic analgesia for bone pain

No drug or alcohol abuse

No other serious illness or medical condition, such as but not limited to: 1. Any infection ≥ Grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 2. No gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease) 3. Crohn's disease or ulcerative colitis 4. Bone marrow dysplasia 5. Fecal incontinence 6. Life-threatening illness unrelated to cancer

No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation Contact: Evelien Nollet, PhD

[email protected]

+3227741571 Locations: Hopital Universitaire Brugmann

Brussels 1020 Belgium

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Brussels 1070 Belgium

Cliniques Universitaires Saint-Luc

Brussels 1200 Belgium

Universitair Ziekenhuis Antwerpen

Edegem 2650 Belgium

AZ Groeninge Kortrijk

Kortrijk Belgium

CHU UCL Namur - Site Sainte-Elisabeth

Namur 5000 Belgium

AZ Turnhout

Turnhout Belgium

CHU Dinant Godinne - UCL Namur

Yvoir 5530 Belgium

Rigshospitalet

Copenhagen Denmark

Institut régional du Cancer Montpellier

Montpellier 34298 France

Ospedale B.Ramazzini

Carpi 41012 Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola Italy

Istituto Europeo di Oncologia

Milano Italy

Medical University Of Gdansk

Gdańsk 80211 Poland

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw Poland

Hospital Del Mar

Barcelona 08003 Spain

Hospital De La Santa Creu I Sant Pau

Barcelona 08041 Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria Spain

Corporacio Sanitaria Parc Tauli

Sabadell Spain

Hospital Universitario de Salamanca

Salamanca 37007 Spain

Inselspital

Bern Switzerland

Kantonsspital St Gallen

St Gallen Switzerland

The Christie NHS Foundation Trust

Manchester United Kingdom

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02194842)

{{footer-clinical-trials-navigation}} Published November 13, 2017

A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy (/clinicaltrials/prostate-cancer/96918-a-randomized-phase-2-trial-of-177luradiolabeled-monoclonal-antibody-huj591-177lu-j591-and-ketoconazole-inpatients-with-high-risk-castrate-biochemically-relapsed-prostate-cancer-afterlocal-therapy.html) {{header-clinical-trials-navigation}}

A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy Condition: Prostate Cancer Intervention: Drug: 177Lu-J591

Drug: Ketoconazole

Drug: Hydrocortisone

Drug: 111In-J591 Purpose: The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT00859781 Sponsor: Weill Medical College of Cornell University Primary Outcome Measures: Measure: Proportion free of radiographically evident metastases at 18 months by CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan

Time Frame: 18 months

Safety Issue: Secondary Outcome Measures: Measure: PSA response rate

Time Frame: every 4 weeks

Safety Issue: Estimated Enrollment: 140 Study Start Date: June 2009 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.

Biochemical progression (rising PSA) after medical or surgical castration

High risk of systemic progression defined as: 1. Rising PSA as defined above and either: 2. Absolute PSA > 20 ng/mL AND/OR 3. PSA doubling time < 8 months

No evidence of local recurrence or distant metastases

Age >18 years.

Serum testosterone < 50 ng/ml

Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.

Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.

Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Use of red blood cell or platelet transfusions within 4 weeks of treatment

Use of hematopoietic growth factors within 4 weeks of treatment

Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment

Prior radiation therapy encompassing >25% of skeleton

Prior treatment with 89-Strontium or 153-Samarium containing compounds (e.g. Metastron®, Quadramet®)

Platelet count <150,000/mm3

Absolute neutrophil count (ANC) <2,000/mm3

Hematocrit <30 percent or Hemoglobin < 10 g/dL

Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN

Serum creatinine >2.5 mg/dL

AST (SGOT) >2x ULN

Bilirubin (total) >1.5x ULN

Serum calcium >11 mg/dL

Active serious infection

Active angina pectoris or NY Heart Association Class III-IV

Karnofsky Performance Status <70

Life expectancy <12 months

History of deep vein thrombosis and/or pulmonary embolus within 3 months of study entry

Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.

Prior investigational therapy (medications or devices) within 6 weeks of treatment.

Prior use of ketoconazole for the purposes of prostate cancer therapy

Known history of HIV.

Currently active other malignancy other than non-melanoma skin cancer. Contact: GUONC Research Team

[email protected] Locations: University of Arizona Cancer Center

Tucson Arizona 85719 United States

Cedars Sinai

Los Angeles California 90048 United States

USC/Norris Comprehensive cancer center

Los Angeles California 90089 United States

Georgetown University Medical Center

Washington District of Columbia 20007 United States

University of Florida, Orlando Health

Orlando Florida 32806 United States

Emory University

Atlanta Georgia 30322 United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis Indiana 46202 United States

University of Iowa Hospitals and Clinics

Iowa City Iowa 52242 United States

The University of Kansas Cancer Center

Westwood Kansas 66205 United States

North Shore Hematology Oncology Associates

East Setauket New York 11733 United States

Weill Cornell Medical College

New York New York 10021 United States

UPMC Cancer Center

Pittsburgh Pennsylvania 15232 United States

University of Utah

Salt Lake City Utah 84108 United States View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT00859781)

{{footer-clinical-trials-navigation}} Published June 29, 2017

A Randomized Phase I Study to Determine the Safety and Immunogenicity of ChAd-MVA Vaccination Compared to MVA Alone With and Without Low Dose Cyclophosphamide in Low and Intermediate Risk Localised Prostate Cancer (/clinical-trials/prostate-cancer/93328-a-randomized-phase-i-study-todetermine-the-safety-and-immunogenicity-of-chad-mva-vaccinationcompared-to-mva-alone-with-and-without-low-dose-cyclophosphamide-inlow-and-intermediate-risk-localised-prostate-cancer.html) {{header-clinical-trials-navigation}}

A Randomized Phase I Study to Determine the Safety and Immunogenicity of ChAd-MVA Vaccination Compared to MVA Alone With and Without Low Dose Cyclophosphamide in Low and Intermediate Risk Localised Prostate Cancer Condition: Prostate Cancer Intervention: Biological: ChAdOx1.5T4

Biological: MVA.5T4

Drug: Cyclophosphamide Purpose: This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine that could be a new way to treat cancer. A vaccine that could alert the immune system to the presence of cancer cells in the body may enable the immune system to target and kill those cells effectively. This vaccine is intended to work by making the immune system kill cells that have a special protein (called 5T4) that is present on the surface of cancer cells. The vaccine is made up of two recombinant viruses ("ChAdOx1" and "MVA") that have been designed to produce the 5T4 protein and have been modified so that they are weakened and cannot reproduce themselves within the body like normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the body's immune system to learn to target this protein and destroy cancer cells. This is a firstin-human study to evaluate the safety and immunogenicity of ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neoadjuvant setting in low and intermediate risk localised prostate cancer patients who have either decided to have their prostate removed or are stable on active surveillance. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02390063 Sponsor: University of Oxford Primary Outcome Measures: Measure: Vaccine safety and immunogenicity

Time Frame: Up to 52 weeks

Safety Issue: Secondary Outcome Measures: Measure: Cellular and humoral immune response with CHAMVA

Time Frame: Up to 52 weeks

Safety Issue:

Measure: Cellular and humoral immune response with MVA

Time Frame: Up to 52 weeks

Safety Issue:

Measure: PSA level change secondary to vaccination

Time Frame: Participants will be followed for the duration of the study, up to 52 weeks

Safety Issue:

Measure: MRI or Gleason score change secondary to vaccination

Time Frame: Participants will be followed for the duration of the study, up to 52 weeks

Safety Issue:

Measure: Regulatory T-cell response

Time Frame: Participants will be followed for the duration of the study, up to 52 weeks

Safety Issue: Estimated Enrollment: 48 Study Start Date: June 2015 Phase: Phase 1 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: (Radical Prostatectomy patients):

Males aged 18 years and older

Histologically confirmed prostate cancer diagnosed on biopsy within 6 months

Clinically localised, low or intermediate risk prostate cancer, i.e.:

Gleason score ≤ 7

Local tumour stage ≤T2c

No evidence of metastases (Nx/N0 and Mx/M0)

PSA ≤ 20 ng/ml

Scheduled for and considered fit for radical prostatectomy

Absence of any indication to perform urgent surgery that would not allow administration of the vaccine during the 12 week period prior to radical prostatectomy

No invasive treatment for prostatic disease within the last 2 years

Subject is free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, and Insulin Dependent Diabetes Mellitus). Note subjects with Non-Insulin Dependent Diabetes Mellitus can be included.

Subject has adequate bone marrow function as defined by an Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) >1200/µL, Platelet Count >100,000/µL.

Subject must practice a reliable form of contraception (barrier or vasectomy) while they are being treated with vaccines and another effective method of birth control must also be used by their partner Inclusion Criteria (Active Surveillance patients)

Males aged 18 and older

Histologically confirmed prostate cancer diagnosed on biopsy within 6 months

Clinically localised, low or intermediate risk prostate cancer, i.e.:

Gleason score ≤ 7

Local tumour stage ≤T2c

No evidence of metastases (Nx/N0 and Mx/M0)

PSA ≤ 20 ng/ml

Stable disease on Active Surveillance for a minimum of 12 months previously

Suitable to remain on Active Surveillance at time of last clinical assessment

No invasive treatment for prostatic disease within the last 2 years

Subject is free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, and Insulin Dependent Diabetes Mellitus). Note subjects with Non-Insulin Dependent Diabetes Mellitus can be included.

Subject has adequate bone marrow function as defined by an Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) >1200/µL, Platelet Count >100,000/µL.

Subject must practice a reliable form of contraception (barrier or vasectomy) while they are being treated with vaccines and another effective method of birth control must also be used by their partner Exclusion Criteria: Diagnosis of any cancer other than prostate cancer within the last 5 years (except basal cell carcinoma)

Any suspicion of metastatic cancer

Any Gleason grade 5 component in the prostatic biopsies

Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period

Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate

Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV

Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)

Platelet count >400,000/µL; Monocytes >80,000/µL; Hemoglobin <11g/dL

Known allergy to neomycin

History of allergic response to previous vaccinia vaccinations

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products

History of hypersensitivity and haemorrhagic cystitis

Any history of anaphylaxis

Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units per week)

History of a serious psychiatric condition or other circumstance s that may be associated with not understanding or complying with the study protocol Contact: Adrian Hill

[email protected]

+441865 857417 Locations: University of Oxford

Oxford OX3 7DQ United Kingdom

Royal Hallamshire Hospital

Sheffield S10 2IF United Kingdom View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02390063)

{{footer-clinical-trials-navigation}} Published January 12, 2017

A Randomized Phase III, Factorial Design, of Cabazitaxel and Pelvic Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse (/clinical-trials/prostate-cancer/93269-a-randomizedphase-iii-factorial-design-of-cabazitaxel-and-pelvic-radiotherapy-in-patientswith-localized-prostate-cancer-and-high-risk-features-of-relapse.html) {{header-clinical-trials-navigation}}

A Randomized Phase III, Factorial Design, of Cabazitaxel and Pelvic Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse Condition: Adenocarcinoma of Prostate, Progression of Prostate Cancer Intervention: Drug: Cabazitaxel

Radiation: Pelvic radiotherapy

Radiation: prostate radiotherapy Purpose: The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with ADT-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT01952223 Sponsor: UNICANCER Primary Outcome Measures: Measure: progression free survival

Time Frame: 10 years

Safety Issue: Secondary Outcome Measures: Measure: prostate-specific antigen response at 3 months

Time Frame: 10 years

Safety Issue:

Measure: biochemical progression-free survival

Time Frame: 10 years

Safety Issue:

Measure: metastases-free survival

Time Frame: 10 years

Safety Issue:

Measure: local relapse-free survival

Time Frame: 10 years

Safety Issue:

Measure: overall survival

Time Frame: 10 years

Safety Issue:

Measure: prostate cancer-specific survival

Time Frame: 10 years

Safety Issue:

Measure: acute toxicity

Time Frame: 10 years

Safety Issue:

Measure: impact of treatment on serum testosterone

Time Frame: 10 years

Safety Issue:

Measure: long-term toxicity

Time Frame: 10 years

Safety Issue:

Measure: predictive biomarkers of treatment efficacy

Time Frame: 10 years

Safety Issue:

Measure: quality of life

Time Frame: 10 years

Safety Issue: Estimated Enrollment: 1048 Study Start Date: September 2013 Phase: Phase 3 Eligibility: Age: minimum 18 Years maximum 75 Years

Gender: Male Inclusion Criteria: 1) Any T histologically confirmed adenocarcinoma of the prostate 2) No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (> 1 cm in small diameter) 3) Gleason score ≥6 4) Meets at least 2 of the following criteria for high-risk:

Gleason score ≥ 8

T3 or T4 disease (T3 defined by MRI is acceptable)

Prostate-specific antigen equal or greater than 20 ng/mL 5) No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization). 6) 18 years ≤ Age≤ 75 years 7) ECOG 0-1 performance status 8) Expected life expectancy of more than 10 years 9) Absolute neutrophil count ≥ 1.5 x 109/L 10) Platelets ≥ 100 x 109/L 11) Hb ≥ 9.0 g/dL 12) Hepatic function: serum bilirubin ≤ 1 ULN; AST and ALT ≤ 2.5 x ULN 13) Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥ 60 mL/min). 14) Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product. 15) Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials. 16) Patients who have received the information sheet and signed the informed consent form. 17) Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria: 1) Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: 1. infection, 2. cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2, 3. uncontrolled diabetes mellitus, 4. current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment), 5. renal disease, 6. active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded, 7. known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air). 2) Other prior malignancy within the last 5 years, except basal cell skin cancer 3) Physical or psychological condition that would preclude study compliance 4) Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80 5) Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 6) Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel. 7) Previous pelvic irradiation that make prostatic irradiation impossible 8) Severe GI disorders precluding pelvic irradiation 9) Patients already included in another therapeutic trial involving an experimental drug 10) Individual deprived of liberty or placed under the authority of a tutor. 11) Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments Contact: Muriel HABIBIAN

[email protected]

+33(0)176647807 Location: Institut Gustave Roussy

Villejuif F-94805 France View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01952223)

{{footer-clinical-trials-navigation}} Published January 10, 2017

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT) (/clinical-trials/prostatecancer/93278-a-randomized-study-of-enzalutamide-in-patients-with-localizedprostate-cancer-undergoing-active-surveillance-enact.html) {{header-clinical-trials-navigation}}

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT) Condition: Prostate Cancer Intervention: Drug: Enzalutamide

Other: Active Surveillance Purpose: The primary purpose of this study is to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance. Study Type: Interventional Clinical Trials Identifier NCT 8-digits: NCT02799745 Sponsor: Astellas Pharma Global Development, Inc. Primary Outcome Measures: Measure: Time to prostate cancer progression

Time Frame: From study screening to end of study (up to three years after screening)

Safety Issue: Secondary Outcome Measures: Measure: Safety assessed by adverse events (AE)

Time Frame: Up to end of study (up to two years)

Safety Issue:

Measure: Incidence of negative biopsies for cancer at 1 year

Time Frame: 1 year

Safety Issue:

Measure: Incidence of negative biopsies for cancer at 2 years

Time Frame: 2 years

Safety Issue:

Measure: Percent of cancer positive cores at 1 year

Time Frame: 1 year

Safety Issue:

Measure: Percent of cancer positive cores at 2 years

Time Frame: 2 years

Safety Issue:

Measure: Time to PSA (Prostate Specific Antigen) progression

Time Frame: From study screening to end of study (up to three years after screening)

Safety Issue:

Measure: Incidence of secondary rise in serum PSA at 1 year

Time Frame: 1 year

Safety Issue:

Measure: Incidence of secondary rise in serum PSA at 2 years

Time Frame: 2 years

Safety Issue:

Measure: Brief Fatigue Index (BFI)

Time Frame: Baseline up to 24 months, approximately every 3-6 months

Safety Issue:

Measure: Medical Outcomes study 12-item short form (SF-12) assessments

Time Frame: Baseline up to 24 months, approximately every 6 months

Safety Issue:

Measure: Expanded Prostate Cancer Index Composite (EPIC) questionnaire (urinary, sexual and hormonal domains)

Time Frame: Baseline up to 24 months, approximately every 6 months

Safety Issue:

Measure: Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire

Time Frame: Baseline up to 24 months, approximately every 6 months

Safety Issue:

Measure: Safety assessed by vital sign measurement: pulse

Time Frame: Up to end of study (up to two years)

Safety Issue:

Measure: Safety assessed by vital sign measurement: blood pressure

Time Frame: Up to end of study (up to two years)

Safety Issue:

Measure: Safety assessed by vital sign measurement: heart rate

Time Frame: Up to end of study (up to two years)

Safety Issue:

Measure: Safety assessed by vital sign measurement: body temperature

Time Frame: Up to end of study (up to two years)

Safety Issue:

Measure: Number of participants with abnormal laboratory values and/or adverse events related to treatment

Time Frame: Up to end of study (up to two years)

Safety Issue: Estimated Enrollment: 222 Study Start Date: May 24, 2016 Phase: Phase 2 Eligibility: Age: minimum 18 Years maximum N/A

Gender: Male Inclusion Criteria: Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.

Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ≤ 6, ECOG status ≤2 and estimated life expectancy >5 years OR intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.

Ability to swallow study drugs and to comply with study requirements throughout the study

Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures

Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following: 1. Condom (barrier method of contraception) AND 2. One of the following is required: i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.

Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration. Exclusion Criteria: Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer

Very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g)

Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate

Use of oral glucocorticoids within 1 month of screening

Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months

Presence of metastatic disease

History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening

Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, or hemoglobin < 6.2 mmol/L (10 g/dL) at screening

Total bilirubin >1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening

Creatinine > 177 µmol/L (> 2 mg/dL) at screening

Albumin < 30 g/L (3.0 g/dL) at screening

Major surgery within 4 weeks prior to Randomization Visit

Clinically significant cardiovascular disease including: 1. Myocardial infarction or uncontrolled angina within 6 months 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4 3. History of clinically significant ventricular arrhythmias 4. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place 5. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening 6. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination 7. Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit

Known hypersensitivity to enzalutamide or any of its components.

Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening Contact: Astellas Pharma Global Development

[email protected]

800-888-7704 Ext. 5473 Locations: Site US10034

Birmingham Alabama 35223 United States

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Toronto Ontario M5G2M9 Canada View trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02799745)

{{footer-clinical-trials-navigation}} Published January 21, 2018

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