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Mevrometostat and Enzalutamide for Metastatic Prostate Cancer

This study is looking at whether combining the investigational drug mevrometostat with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer (mCSPC). This is prostate cancer that has spread to other parts of the body but still responds to hormone therapy. You might be able to join if you are at least 18 years old, have confirmed prostate cancer that has spread, and have not yet received certain other treatments for your mCSPC. The main goal is to see if the combination treatment can prevent the cancer from growing or spreading further (radiographic progression-free survival) for up to about 4 years. The study plans to enroll 1000 participants.

Study design
This is a global, randomized, double-blind, placebo-controlled Phase 3 study. It will compare mevrometostat plus enzalutamide to a placebo plus enzalutamide, with 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for radiographic progression-free survival for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07028853

This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~1,000 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:MevrometostatPlaceboEnzalutamide

At a glance

Recruiting sites
329 of 337 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Progression Free Survival (rPFS)
Measured over Randomization up to approximately 4 years

Conditions

Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Hormone Sensitive Prostate Cancer
Prostate Cancer
Cancer of the Prostate

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NCT07028853

Where you'd take part

This study runs at 337 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • "Venizeleio-Pananeio" General Hospital of Herakleion

    Heraklion, Greeceno site contact published

    Recruiting

  • Advanced Urology Institute, LLC

    Largo, Floridano site contact published

    Recruiting

  • AdventHealth Medical Group Urology of Denver

    Denver, Coloradono site contact published

    Recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí, Greeceno site contact published

    Recruiting

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, Barcelona, Spainno site contact published

    Recruiting

  • Ankara Bilkent Şehir Hastanesi

    Ankara, Turkey (Türkiye)no site contact published

    Recruiting

  • Ankara University Health Practice and Research Hospitals

    Ankara, Turkey (Türkiye)no site contact published

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], South Koreano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Radiographic Progression Free Survival (rPFS)Randomization up to approximately 4 years

    rPFS is defined as the time from randomization until PD based on BICR assessment per RECIST v1.1 (soft tissue disease) and PCWG3 (bone disease), or death due to any cause, whichever occurs first.