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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.

RecruitingPhase 3

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

Who can join

Ages 18 and older · Men

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.

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 1,000 · Started: Sep 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07028853

Locations in the U.S.

AlabamaClearview Cancer Institute, Huntsville
Clearview Cancer Institute (Crestwood), Huntsville
ArizonaIronwood Physicians P.C. dba Ironwood Cancer and Research Centers, Chandler
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Gilbert
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Glendale
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Goodyear
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Mesa
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Mesa
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Phoenix
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Scottsdale
ArkansasHighlands Oncology Group, PA, Fayetteville
Highlands Oncology Group, PA, Rogers
Highlands Oncology Group, PA, Springdale
CaliforniaUCLA Hematology/Oncology - Alhambra, Alhambra
UCLA Hematology/Oncology - Atascadero, Atascadero
Cedars-Sinai Cancer Beverly Hills, Beverly Hills
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location), Beverly Hills
UCLA Hematology/Oncology - Beverly Hills, Beverly Hills
UCLA Hematology/Oncology - Burbank, Burbank
UCLA Hematology/Oncology - Encino, Encino
UCLA Hematology/Oncology - Irvine, Irvine
UCLA Hematology/Oncology - Laguna Hills, Laguna Hills
Cedars-Sinai Cancer at Cedars-Sinai Medical Center, Los Angeles
Ronald Reagan UCLA Medical Center - Drug Information Center, Los Angeles
UCLA Department of Medicine - Hematology/Oncology, Los Angeles
UCLA Hematology/Oncology, Los Angeles
UCLA Hematology/Oncology - Marina del Rey, Marina del Rey
UCLA Hematology/Oncology - Pasadena, Pasadena
UCLA Hematology/Oncology - Porter Ranch, Porter Ranch
UCLA Hematology/Oncology - San Luis Obispo, San Luis Obispo
UCLA Hematology/Oncology - Santa Barbara, Santa Barbara
UCLA Hematology/Oncology- Santa Monica, Santa Monica
UCLA Hematology/Oncology - Torrance, Torrance
UCLA Hematology/Oncology - Santa Clarita, Valencia
UCLA Hematology/Oncology - Ventura, Ventura
UCLA Hematology/Oncology - Westlake, Westlake Village
ColoradoAdventHealth Medical Group Urology of Denver, Denver
FloridaAdvanced Urology Institute, LLC, Largo
GeorgiaTennessee Oncology, PLLC - Dalton, Dalton
Tennessee Oncology, PLLC - Ringgold, Ringgold
IllinoisAssociated Urological Specialists - Chicago Ridge, Chicago Ridge
Cancer Care Specialists of Illinois, Decatur
Cancer Care Specialists of Illinois, O'Fallon
MichiganMichigan Institute of Urology, PC, Troy
New JerseyMSK Basking Ridge, Basking Ridge
MSK Monmouth, Middletown
MSK Bergen, Montvale
New YorkMSK Commack, Commack
MSKCC-Westchester (500 Westchester Ave.), Harrison
Integrated Medical Professionals, Lake Success
Memorial Sloan Kettering Cancer Center (IDS Pharmacy), Long Island City
Evelyn H. Lauder Breast and Imaging Center (BAIC)., New York
Memorial Sloan Kettering Cancer Center - Main Campus, New York
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center, New York
University of Rochester Medical Center, Rochester
University of Rochester, Cancer Center Pharmacy (Investigational Product), Rochester
Integrated Medical Professionals, Seaford
Montefiore Einstein Comprehensive Cancer Center, The Bronx
Montefiore Medical Center- Montefiore Medical Park, The Bronx
MSK Nassau., Uniondale
North CarolinaDuke Cancer Center Cary, Cary
Duke University, Durham
Duke University Medical Center (location of scans), Durham
Duke University Medical Center - Duke Cancer Center, Durham
Duke University Medical Center - Duke University Hospital (location of scans), Durham
Duke Cancer Center Raleigh, Raleigh
Duke Raleigh Hospital, Raleigh
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines), Raleigh
OhioUniversity Hospitals Seidman Cancer Center at UH Avon Health Center, Avon
TriState Urologic Services PSC Inc. dba The Urology Group, Cincinnati
University Hospitals Cleveland Medical Center, Cleveland
University Hospitals Seidman Cancer Center at UH Mentor Health Center, Mentor
UH Minoff Health Center at Chagrin Highlands, Orange
PennsylvaniaMidLantic urology, Bala-Cynwyd
The Centers for Advanced Urology d/b/a Keystone Urology Specialist, Lancaster
South CarolinaCarolina Urologic Research Center, LLC, Myrtle Beach
Grand Strand Medical Center, Myrtle Beach
Parkway Surgery Center, Myrtle Beach
TennesseeTennessee Oncology PLLC, Chattanooga
Tennessee Oncology, PLLC - Chattanooga Downtown, Chattanooga
Tennessee Oncology, PLLC - Chattanooga East, Chattanooga
Tennessee Oncology, PLLC - Chattanooga Med Park II, Chattanooga
Tennessee Oncology, PLLC - Chattanooga Memorial, Chattanooga
Tennessee Oncology, PLLC - Cleveland, Cleveland
Tennessee Oncology, PLLC - Cookeville, Cookeville
Tennessee Oncology, PLLC - Dickson, Dickson
Tennessee Oncology, PLLC - Franklin, Franklin
Tennessee Oncology, PLLC - Gallatin, Gallatin
The West Clinic, PLLC dba West Cancer Center, Germantown
Tennessee Oncology Hendersonville, Hendersonville
Tennessee Oncology, PLLC - Lebanon, Lebanon
Tennessee Oncology, PLLC - Mount Juliet, Mount Juliet
Tennessee Oncology, PLLC - Murfreesboro, Murfreesboro
Tennessee Oncology, PLLC - Investigational Drug Services, Nashville
Tennessee Oncology, PLLC - Nashville Elliston Place Plaza Medical Oncology & Hematology Clinic, Nashville
Tennessee Oncology, PLLC - Nashville Saint Thomas West, Nashville
Tennessee Oncology, PLLC - Nashville Skyline, Nashville
Tennessee Oncology, PLLC - Nashville Southern Hills, Nashville
Urology Associates, P.C., Nashville
Tennessee Oncology, PLLC - Shelbyville, Shelbyville
Tennessee Oncology, PLLC - Smyrna, Smyrna
TexasUniversity of Texas Southwestern Medical Center, Dallas
University of Texas Southwestern Medical Center - Simmons Cancer Center, Dallas
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital, Dallas
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital, Dallas
University of Texas Southwestern Simmons Cancer Center - Redbird, Dallas
University of Texas Southwestern Simmons Cancer Center - Fort Worth, Fort Worth
US Oncology Investigational Product Center (IPC), Irving
University of Texas Southwestern Simmons Cancer Center - Richardson/Plano, Richardson
UtahHuntsman Cancer Institute, Salt Lake City
VirginiaBlue Ridge Cancer Care, Blacksburg
UVA Health Cancer Care Pantops, Charlottesville
University of Virginia, Charlottesville
University of Virginia Comprehensive Cancer Center, Charlottesville
Blue Ridge Cancer Care, Low Moor
Blue Ridge Cancer Care, Roanoke
Blue Ridge Cancer Care, Salem
Blue Ridge Cancer Care, Wytheville
WashingtonNorthwest Medical Specialties, PLLC, Bonney Lake
Northwest Medical Specialties, PLLC, Federal Way
Northwest Medical Specialties, PLLC, Gig Harbor
Northwest Medical Specialties, PLLC, Puyallup
Northwest Medical Specialties, PLLC, Tacoma
WisconsinUniversity of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.