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NCT07028853From ClinicalTrials.govRecruiting

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.

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)

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

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Pfizer
Enrolment target
1,000
Started
28 September 2025
Main results due
12 September 2028
Study sites
307
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Men only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 and have not yet received chemotherapy in the mCSPC setting.

Study sites(307)

  • 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

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, United States

    Recruiting

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, United States

    Recruiting

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Phoenix, Arizona, United States

    Recruiting

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Scottsdale, Arizona, United States

    Recruiting

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas, United States

    Recruiting

  • Highlands Oncology Group, PA

    Rogers, Arkansas, United States

    Recruiting

  • Highlands Oncology Group, PA

    Springdale, Arkansas, United States

    Recruiting

  • UCLA Hematology/Oncology - Alhambra

    Alhambra, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Atascadero

    Atascadero, California, United States

    Recruiting

  • Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)

    Beverly Hills, California, United States

    Recruiting

  • Cedars-Sinai Cancer Beverly Hills

    Beverly Hills, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Beverly Hills

    Beverly Hills, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Burbank

    Burbank, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Encino

    Encino, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Irvine

    Irvine, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Laguna Hills

    Laguna Hills, California, United States

    Recruiting

  • Cedars-Sinai Cancer at Cedars-Sinai Medical Center

    Los Angeles, California, United States

    Recruiting

  • Ronald Reagan UCLA Medical Center - Drug Information Center

    Los Angeles, California, United States

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, United States

    Recruiting

  • UCLA Hematology/Oncology

    Los Angeles, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Marina del Rey

    Marina del Rey, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Pasadena

    Pasadena, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Porter Ranch

    Porter Ranch, California, United States

    Recruiting

  • UCLA Hematology/Oncology - San Luis Obispo

    San Luis Obispo, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California, United States

    Recruiting

  • UCLA Hematology/Oncology- Santa Monica

    Santa Monica, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Torrance

    Torrance, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Santa Clarita

    Valencia, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Ventura

    Ventura, California, United States

    Recruiting

  • UCLA Hematology/Oncology - Westlake

    Westlake Village, California, United States

    Recruiting

  • AdventHealth Medical Group Urology of Denver

    Denver, Colorado, United States

    Recruiting

  • Advanced Urology Institute, LLC

    Largo, Florida, United States

    Recruiting

  • Tennessee Oncology, PLLC - Dalton

    Dalton, Georgia, United States

    Recruiting

  • Tennessee Oncology, PLLC - Ringgold

    Ringgold, Georgia, United States

    Recruiting

  • Associated Urological Specialists - Chicago Ridge

    Chicago Ridge, Illinois, United States

    Recruiting

  • Cancer Care Specialists of Illinois

    Decatur, Illinois, United States

    Recruiting

  • Cancer Care Specialists of Illinois

    O'Fallon, Illinois, United States

    Recruiting

  • Michigan Institute of Urology, PC

    Troy, Michigan, United States

    Recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, United States

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, United States

    Recruiting

  • MSK Bergen

    Montvale, New Jersey, United States

    Recruiting

  • MSK Commack

    Commack, New York, United States

    Recruiting

  • MSKCC-Westchester (500 Westchester Ave.)

    Harrison, New York, United States

    Recruiting

  • Integrated Medical Professionals

    Lake Success, New York, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center (IDS Pharmacy)

    Long Island City, New York, United States

    Recruiting

  • Evelyn H. Lauder Breast and Imaging Center (BAIC).

    New York, New York, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, United States

    Recruiting

  • Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, United States

    Recruiting

  • University of Rochester, Cancer Center Pharmacy (Investigational Product)

    Rochester, New York, United States

    Recruiting

  • Integrated Medical Professionals

    Seaford, New York, United States

    Recruiting

  • Montefiore Einstein Comprehensive Cancer Center

    The Bronx, New York, United States

    Recruiting

  • Montefiore Medical Center- Montefiore Medical Park

    The Bronx, New York, United States

    Recruiting

  • MSK Nassau.

    Uniondale, New York, United States

    Recruiting

Showing 60 of 307 sites — filter to narrow it down. 140 of the 307 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07028853. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enza | Trialion