Select Ongoing Trials Currently Enrolling Patients with Prostate Cancer

The following clinical trials represent a selection of key studies that are currently recruiting patients with prostate cancer for inclusion in investigations of new therapies and new regimens of existing treatments for patients with prostate cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.


1 Enzalutamide plus ADT with and without Pembrolizumab for Metastatic Hormone-Sensitive Prostate Cancer

The purpose of this randomized, double-blind, phase 3 clinical trial is to assess the efficacy and safety of pembrolizumab (Keytruda) plus enzalutamide (Xtandi) plus androgen-deprivation therapy (ADT) versus placebo plus enzalutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer. Men aged ≥18 years with histologically or cytologically confirmed metastatic prostate cancer and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT.

The primary outcome measures are radiographic progression-free survival (rPFS) and overall survival (OS). The secondary outcome measures include time to initiation of the first subsequent anticancer therapy or death (TFST), time to symptomatic skeletal-related event, time to prostate-specific antigen (PSA) progression, time to radiographic soft tissue progression, time to pain progression (TTPP), time from randomization to disease progression, PSA response rate, PSA undetectable rate, objective response rate (ORR), and duration of response (DOR), number of patients who experience an adverse event, and number of patients who discontinue treatment due to an adverse event. This study expects to enroll 1232 patients at multiple locations across the United States and abroad. For more information, contact the Merck Sharp & Dohme Corporation at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT04191096.


2 Cabozantinib plus Atezolizumab versus Second Novel Hormonal Therapy in Metastatic Prostate Cancer

The purpose of this multicenter, randomized, open-label, controlled, phase 3 clinical trial is to determine the efficacy and safety of cabozantinib (Cabometyx) given in combination with atezolizumab (Tecentriq) versus a second novel hormonal therapy (NHT) in patients with metastatic prostate cancer who have previously been treated with one, and only one, NHT for their prostate cancer disease. Men aged ≥18 years with metastatic adenocarcinoma of the prostate and an ECOG performance status of 0 to 1 who have received previous treatment with 1 NHT for their disease may be eligible for enrollment if other criteria are met. Eligible patients will receive cabozantinib plus atezolizumab or a second NHT (abiraterone [Zytiga] or enzalutamide).

The primary outcome measures are duration of PFS and duration of OS. The secondary outcome measure is ORR. This study plans to enroll 580 patients at multiple locations in the United States. For more information, contact Exelixis Clinical Trials at 1-888-393-5494 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT04446117.


3 Capivasertib plus Abiraterone for Patients with Metastatic Hormone-Sensitive Prostate Cancer and PTEN Deficiency

The purpose of this randomized, double-blind, placebo-controlled phase 3 clinical trial is to assess the efficacy and safety of capivasertib (AZD5363) plus abiraterone versus placebo plus abiraterone for patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency. Men aged 18 to 130 years with asymptomatic or mildly symptomatic de novo metastatic hormone-sensitive prostate adenocarcinoma, PTEN deficiency, and an ECOG/WHO performance status of 0 to 1 with minimum life expectancy of 12 weeks may be eligible for enrollment if other criteria are met. Patients will receive capivasertib plus abiraterone or placebo plus abiraterone.

The primary outcome measure is rPFS. The secondary outcome measures include OS, TFST, symptomatic skeletal event-free survival, TTPP, time to PSA progression, time to castration resistance, PFS after next-line treatment, and tolerability. This study plans to enroll 1000 patients in the United States and abroad. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT04493853.


4 Radium-223 plus Docetaxel for Patients with Metastatic Castration-Resistant Prostate Cancer

The purpose of this randomized, open-label, phase 3 study is to evaluate any positive or negative effects of using Radium-223 in combination with docetaxel chemotherapy versus docetaxel monotherapy in patients with metastatic prostate cancer. Men aged ≥18 years with a documented progressive metastatic castration-resistant prostate cancer, ≥2 bone lesions, and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive docetaxel or docetaxel plus Radium-223. The primary outcome measure is OS.

This study expects to enroll 738 patients at multiple locations across the United States and abroad. For more information, contact Michael Morris, MD, at 1-646-422-4469 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT03574571.


5 ProstAtak Immunotherapy plus Standard Radiation Therapy for Localized Prostate Cancer

The purpose of this randomized, phase 3 clinical trial is to evaluate the efficacy of ProstAtak immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. Men aged ≥18 years with localized prostate cancer meeting the National Comprehensive Cancer Network (NCCN) criteria of intermediate risk or patients having only 1 NCCN high-risk feature and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive ProstAtak plus valacyclovir plus radiation therapy with or without ADT or placebo plus valacyclovir plus radiation therapy with or without ADT.

The primary outcome measures are disease-free survival. The secondary outcome measures include prostate cancer–specific survival, OS, PSA nadir, and tolerability. This study plans to enroll 711 patients at multiple locations in the United States. For more information, please contact Advantagene (dba Candel Therapeutics) at 1-617-916-5445 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01436968.


6 Nivolumab versus Placebo in Combination with Docetaxel for Advanced Castration-Resistant Prostate Cancer

The purpose of this randomized, double-blind, phase 3 clinical trial is to assess the efficacy and safety of nivolumab (Opdivo) plus docetaxel (Taxotere) in patients with advanced castration-resistant prostate cancer who have progressed after second-generation hormonal manipulation. Men aged ≥18 years with current evidence of metastatic disease and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab plus docetaxel plus prednisone or placebo plus docetaxel plus prednisone.

The primary outcome measures are rPFS and OS. The secondary outcome measures include ORR, time to response, DOR, PSA response rate, time to PSA progression, tolerability, incidence of deaths, incidence of laboratory abnormalities, and median TTPP. This study plans to enroll 984 patients at multiple locations across the United States and abroad. For more information, please contact the sites directly. If there is no contact information, please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. First line of the e-mail MUST contain NCT # and Site #. The NLM Identifier is NCT04100018.


7 Safety and Efficacy of Relugolix for Advanced Prostate Cancer

The purpose of this randomized, multinational, open-label, parallel-group, phase 3 clinical trial is to evaluate the efficacy and safety of relugolix for maintaining serum testosterone suppression to castrate levels in patients with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous ADT. Men aged ≥18 years with prostate cancer who are candidates for at least 1 year of continuous ADT and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive relugolix 120 mg orally once daily or leuprolide acetate depot suspension 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injections.

The primary outcome measure is sustained castration rate. The secondary outcome measures include castration rate, confirmed PSA response rate, profound castration rate, castration resistance-free survival, testosterone recovery to 280 ng/dL, time to PSA progression, and absolute value and change from baseline in quality-of-life total score. This study plans to enroll 1100 patients across the United States and abroad.

There are 2 analyses for this trial: a primary analysis and a final analysis. The primary analysis of efficacy and safety will occur after approximately 915 participants have been randomized and evaluated for 48 weeks and completed the 30-day safety follow-up visit or discontinued early with 30-day safety follow-up. The final analysis will occur after approximately 390 participants with metastatic disease (or approximately 1100 participants with or without metastatic prostate cancer) have been randomized from any sites to the study. To support registration in China, the study will continue to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of 138 participants. For more information, contact Clinical Trials at Myovant at 1-650-278-8743 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT03085095.


8 Rucaparib versus Physician’s Choice of Therapy for Metastatic Castration-Resistant Prostate Cancer and Homologous Recombination Gene Deficiency

The purpose of this randomized, multicenter, open-label, phase 3 clinical trial is to determine how patients with metastatic castration-resistant prostate cancer and evidence of a homologous recombination gene deficiency respond to treatment with rucaparib (Rubraca) versus treatment with physician’s choice of abiraterone acetate, enzalutamide, or docetaxel. Men aged ≥18 years with histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic, who are surgically or medically castrated, have experienced disease progression after having received 1 previous next-generation androgen receptor-targeted therapy for castration-resistant disease, and who have a deleterious mutation in a BRCA1/2 or ATM gene may be eligible for enrollment if other criteria are met. Eligible patients will receive rucaparib or physician’s choice of abiraterone acetate, enzalutamide, or docetaxel.

The primary outcome measure is rPFS. The secondary outcome measures include ORR, DOR, time to PSA progression, PSA response, change in patient-reported outcome, clinical benefit rate, OS, trough plasma pharmacokinetic of rucaparib, and tolerability. This study plans to enroll 400 patients across the United States and abroad. For more information, contact Clovis Oncology Clinical Trial Navigation Service at 1-855-262-3040 (US) or 1-303-625-5160 (outside the US) or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02975934.


9 Apalutamide for High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

The purpose of this randomized, double-blind, placebo-controlled phase 3 clinical trial is to determine whether androgen blockage administered before and after radical prostatectomy will increase the rate of pathologic complete response and lead to better overall outcomes. Men aged ≥18 years with prostate cancer and high-risk disease who are candidates for radical prostatectomy with pelvic lymph node dissection and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Patients will receive apalutamide (Erleada) plus ADT or placebo plus ADT.

The primary outcome measures are percentage of patients with pathologic complete response and metastasis-free survival. The secondary outcome measures include PSA-free survival, PFS, tolerability, and treatment compliance rate. This study expects to enroll 1500 patients at multiple locations across the United States and abroad. For more information, contact 1-844-434-4210 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT03767244.


10 Curcumin to Prevent Progression of Low-Risk Prostate Cancer Under Active Surveillance

A major concern for patients and physicians using active surveillance for prostate cancer is the risk for disease progression. Several reviews of active surveillance suggest that stage or grade progression occur in approximately 30% of patients, with some patients choosing treatment due to anxiety. OS in active surveillance series is uniformly high, but the need for close monitoring and anxiety associated with risk of progression has inhibited use among patients. With the rising use of active surveillance, there is a role for therapies to reduce the risk for progression in this population. One promising source of therapies involves the use of nutraceuticals for the prevention and treatment of diseases. Curcumin is a widely studied nutraceutical that was first discovered approximately 2 centuries ago from the rhizomes of Curcuma longa (turmeric).

The purpose of this randomized, double-blind, placebo-controlled, phase 3 clinical trial is to determine whether the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance. Men aged 40 to 89 years with biopsy-proven, low-risk, localized prostate cancer; Gleason score of ≤6 with no Gleason pattern 4; serum PSA ≤15 ng/mL; and life expectancy >5 years may be eligible for enrollment if other criteria are met. Eligible patients will receive curcumin or placebo.

The primary outcome measure is rate of disease progression (the receipt of primary therapy or pathologic progression [>4 cores involved, ≥50% of any core involved, or any Gleason score ≥7]). This study expects to enroll 291 patients at UT Southwestern Medical Center, Dallas, TX. For more information, contact Esperanza Jackson at 1-214-645-8787 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Yair Lotan, MD, at 1-214-645-8787 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT03769766.

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