Mevrometostat plus enzalutamide versus enzalutamide alone for men with metastatic castration‑sensitive prostate cancer who are ARPI‑naïve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, multicenter, randomized, double‑blind, placebo‑controlled Phase 3 trial enrolls men with metastatic castration‑sensitive prostate cancer who are ARPI‑naïve and have not received chemotherapy in the mCSPC setting. Participants are randomized 1:1 to receive mevrometostat (PF‑06821497) plus enzalutamide or placebo plus enzalutamide alongside standard androgen‑deprivation therapy as needed. The study includes screening, treatment, safety follow‑up, and long‑term follow‑up visits, with prior short‑term ADT (up to 3 months) allowed if there is no radiographic progression or rising PSA before Day 1. Efficacy and safety endpoints will compare progression and adverse events between the combination and control arms.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
* Participants must have ECOG PS 0 or 1.

Exclusion Criteria

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease.
* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.
* Previous administration with an investigational product (drug or vaccine) within 30 days.
* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.
* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
* Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
* Inadequate organ function.
* Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.

Where it's running

• Clearview Cancer Institute (Crestwood)
  Huntsville, Alabama, United States Recruiting
• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  Chandler, Arizona, United States Recruiting
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  Gilbert, Arizona, United States Recruiting
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  Glendale, Arizona, United States Recruiting
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  Goodyear, Arizona, United States Recruiting

+269 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-count SPECT imaging to guide Radium-223 treatment for men with bone-metastatic prostate cancer

  This study tests whether low-count quantitative SPECT can help tailor Radium-223 therapy for men with prostate cancer that has spread to the bones.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07221825

• EHR-based annual PSA reminder and shared decision-making program across a 10-hospital system

  This trial will test whether an annual electronic health record reminder that prompts shared decision-making and guideline-based referral improves PSA screening and appropriate follow-up for men at average or high risk in a large health system.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07109427

• Using AI to help find prostate cancer on MRI

  This study tests whether an AI software can help doctors find suspicious lesions on prostate MRI in men aged 55–80 who are having a pre-biopsy MRI and planned prostate biopsy.

  Recruiting Case Comprehensive Cancer Center · Cleveland, Ohio · NCT07084779

• Evaluating treatment outcomes for hormone-sensitive metastatic prostate cancer

  This study looks at how well different treatments work for men with hormone-sensitive metastatic prostate cancer who have just started hormone therapy.

  Recruiting at 3 sites Santa Chiara Hospital · Orbassano, Torino and 2 other locations · NCT06473259

• Radiation therapy for recurrent prostate cancer

  This study is testing a new way to use radiation therapy for men with recurrent prostate cancer to see if it helps control the cancer better while also keeping their quality of life intact.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06392295

• Treatment for recurrent prostate cancer with metastases

  This study is testing whether combining hormone therapy with targeted radiation or surgery can help men with recurrent prostate cancer live longer without their cancer spreading.

  Recruiting Phase 3 Universitaire Ziekenhuizen KU Leuven · Leuven · NCT05352178

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.