Clinical trials are essential for advancing care in prostate cancer, offering patients access to innovative therapies that may be more effective than standard options. From a clinician’s perspective, trials provide opportunities to tailor treatment based on evolving science while ensuring rigorous safety monitoring. They allow evaluation of novel drugs, surgical techniques, and imaging methods that could improve survival and quality of life. Participation also contributes to broader medical knowledge, benefiting future patients. Importantly, clinical trials empower patients by involving them directly in research, giving them hope and expanded options when conventional therapies may be limited or less effective.

The following five clinical trials are all phase 3 trials that recently received updates. All five trials are either active or complete, and their most recent updates were within the last three months.

Overview of the 5 Prostate Cancer Phase 3 Clinical Trials
Study TitleResults Posted?Completed?Latest Update PostedStart DatePrimary Completion Date
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/​KEYNOTE-991)YesActiveAugust 29, 2025February 12, 2020October 31, 2022
68Ga-PSMA-11 PET/​CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate CancerYesCompletedJuly 18, 2025May 9, 2022December 21, 2023
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/​KEYNOTE-921)YesCompletedJuly 18, 2025May 2, 2019June 20, 2022
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)YesActiveJune 27, 2025April 14, 2022February 15, 2024
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)YesCompletedJune 12, 2025February 6, 2020June 1, 2023
5 Recently Updated, Phase 3 Clinical Trials for Prostate Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/​KEYNOTE-991)

  • Sponsor: Merck Sharp & Dohme LLC
  • Goal: Assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC.
  • Interventions: Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT), Placebo
  • Primary Outcome Measures: Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR); Overall Survival (OS).
  • Timeframe: Up to approximately 32 months; Up to approximately 32 months.
  • Study Details
  • Source

68Ga-PSMA-11 PET/​CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer

  • Sponsor: Mayo Clinic
  • Goal: This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy.
  • Interventions: Computed Tomography, Gallium Ga 68 Gozetotide, Positron Emission Tomography
  • Primary Outcome Measures: Patients reporting adverse reactions.
  • Timeframe: From the time of injection until the time after imaging scan is complete, up to 1 day.
  • Study Details
  • Source

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/​KEYNOTE-921)

  • Sponsor: Merck Sharp & Dohme LLC
  • Goal: Assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
  • Interventions: Pembrolizumab, Docetaxel, Prednisone, Placebo, Dexamethasone
  • Primary Outcome Measures: Overall Survival (OS); Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
  • Timeframe: Up to 36.5 months; Up to approximately 28 months.
  • Study Details
  • Source

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)

  • Sponsor: Eli Lilly and Company
  • Goal: The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse.
  • Interventions: Abemaciclib, Abiraterone, Prednisone or Prednisolone, Placebo for Abemaciclib
  • Primary Outcome Measures: Radiographic Progression-Free Survival (rPFS) Assessed by Investigator.
  • Timeframe: From date of randomization to radiographic disease progression or death from any cause (up to 22 months).
  • Study Details
  • Source

A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)

  • Sponsor: Bristol-Myers Squibb
  • Goal: The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.
  • Interventions: Nivolumab, Prednisone, Docetaxel, Placebo
  • Primary Outcome Measures: Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3); Overall Survival (OS).
  • Timeframe: From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months); From randomization to the date of death from any cause (Up to approximately 31 months).
  • Study Details
  • Source
Related Guidelines:

Guidelines on Prostate Cancer, 2025

  • European Association of Urology, European Association of Nuclear Medicine, European Society for Radiotherapy and Oncology

Early Detection of Prostate Cancer, 2023

  • American Urological Association, Society of Urologic Oncology

Genetic Testing in Prostate Cancer, 2023

  • Canadian Urological Association

Bone Health and Bone-Targeted Therapies for Prostate Cancer, 2025

  • Cancer Care Ontario

Advanced Prostate Cancer, 2023

  • American Urological Association, Society of Urologic Oncology

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