AzTrials
AzTrials

Metastatic Castration Sensitive Prostate Cancer (mCSPC)Phase 3NCT07028853

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 study testing Mevrometostat and Enzalutamide in people with Metastatic Castration Sensitive Prostate Cancer (mCSPC) and Hormone Sensitive Prostate Cancer, run by Pfizer at 319 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Mevrometostat and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
319 sitesin 26 countries
Study dates
28 Sep 2025to 8 Dec 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

319 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

319 sites in 26 countries

United States127 sites, 127 recruiting

  • UCLA Hematology/Oncology - Alhambra

    Alhambra, California, 91801

    Recruiting

  • UCLA Hematology/Oncology - Atascadero

    Atascadero, California, 93422

    Recruiting

  • University Hospitals Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

    Recruiting

  • MidLantic urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

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

    Beverly Hills, California, 90211

    Recruiting

  • Cedars-Sinai Cancer Beverly Hills

    Beverly Hills, California, 90211

    Recruiting

  • UCLA Hematology/Oncology - Beverly Hills

    Beverly Hills, California, 90212

    Recruiting

  • Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

    Recruiting

  • Northwest Medical Specialties, PLLC

    Bonney Lake, Washington, 98391

    Recruiting

  • UCLA Hematology/Oncology - Burbank

    Burbank, California, 91505

    Recruiting

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Recruiting

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

    Chandler, Arizona, 85224

    Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Recruiting

  • UVA Health Cancer Care Pantops

    Charlottesville, Virginia, 22911

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga Downtown

    Chattanooga, Tennessee, 37403

    Recruiting

  • Tennessee Oncology PLLC

    Chattanooga, Tennessee, 37404

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga Med Park II

    Chattanooga, Tennessee, 37404

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga Memorial

    Chattanooga, Tennessee, 37404

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga East

    Chattanooga, Tennessee, 37421

    Recruiting

  • Associated Urological Specialists - Chicago Ridge

    Chicago Ridge, Illinois, 60415

    Recruiting

  • TriState Urologic Services PSC Inc. dba The Urology Group

    Cincinnati, Ohio, 45212

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Tennessee Oncology, PLLC - Cleveland

    Cleveland, Tennessee, 37311

    Recruiting

  • MSK Commack

    Commack, New York, 11725

    Recruiting

  • Tennessee Oncology, PLLC - Cookeville

    Cookeville, Tennessee, 38501

    Recruiting

  • University of Texas Southwestern Medical Center - Simmons Cancer Center

    Dallas, Texas, 75235

    Recruiting

  • University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital

    Dallas, Texas, 75235

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Redbird

    Dallas, Texas, 75237

    Recruiting

  • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

    Dallas, Texas, 75390

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Tennessee Oncology, PLLC - Dalton

    Dalton, Georgia, 30720

    Recruiting

  • Cancer Care Specialists of Illinois

    Decatur, Illinois, 62526

    Recruiting

  • AdventHealth Medical Group Urology of Denver

    Denver, Colorado, 80210

    Recruiting

  • Tennessee Oncology, PLLC - Dickson

    Dickson, Tennessee, 37055

    Recruiting

  • Duke University Medical Center (location of scans)

    Durham, North Carolina, 27710

    Recruiting

  • Duke University Medical Center - Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

  • Duke University Medical Center - Duke University Hospital (location of scans)

    Durham, North Carolina, 27710

    Recruiting

  • Duke University

    Durham, North Carolina, 27713

    Recruiting

  • UCLA Hematology/Oncology - Encino

    Encino, California, 91436

    Recruiting

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas, 72703

    Recruiting

  • Northwest Medical Specialties, PLLC

    Federal Way, Washington, 98003

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Tennessee Oncology, PLLC - Franklin

    Franklin, Tennessee, 37067

    Recruiting

  • Tennessee Oncology, PLLC - Gallatin

    Gallatin, Tennessee, 37066

    Recruiting

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee, 38138

    Recruiting

  • Northwest Medical Specialties, PLLC

    Gig Harbor, Washington, 98332

    Recruiting

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

    Gilbert, Arizona, 85297

    Recruiting

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

    Glendale, Arizona, 85306

    Recruiting

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

    Goodyear, Arizona, 85395

    Recruiting

  • MSKCC-Westchester (500 Westchester Ave.)

    Harrison, New York, 10604

    Recruiting

  • Tennessee Oncology Hendersonville

    Hendersonville, Tennessee, 37075

    Recruiting

  • Clearview Cancer Institute (Crestwood)

    Huntsville, Alabama, 35801

    Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

    Recruiting

  • UCLA Hematology/Oncology - Irvine

    Irvine, California, 92604

    Recruiting

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063

    Recruiting

  • UCLA Hematology/Oncology - Laguna Hills

    Laguna Hills, California, 92653

    Recruiting

  • Integrated Medical Professionals

    Lake Success, New York, 11042

    Recruiting

  • The Centers for Advanced Urology d/b/a Keystone Urology Specialist

    Lancaster, Pennsylvania, 17604

    Recruiting

  • Advanced Urology Institute, LLC

    Largo, Florida, 33771

    Recruiting

  • Tennessee Oncology, PLLC - Lebanon

    Lebanon, Tennessee, 37090

    Recruiting

  • Memorial Sloan Kettering Cancer Center (IDS Pharmacy)

    Long Island City, New York, 11101

    Recruiting

  • Cedars-Sinai Cancer at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Ronald Reagan UCLA Medical Center - Drug Information Center

    Los Angeles, California, 90095

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

    Recruiting

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

    Recruiting

  • Blue Ridge Cancer Care

    Low Moor, Virginia, 24457

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Recruiting

  • UCLA Hematology/Oncology - Marina del Rey

    Marina del Rey, California, 90292

    Recruiting

  • University Hospitals Seidman Cancer Center at UH Mentor Health Center

    Mentor, Ohio, 44060

    Recruiting

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

    Mesa, Arizona, 85202

    Recruiting

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

    Mesa, Arizona, 85206

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • MSK Bergen

    Montvale, New Jersey, 07645

    Recruiting

  • Tennessee Oncology, PLLC - Mount Juliet

    Mount Juliet, Tennessee, 37122

    Recruiting

  • Tennessee Oncology, PLLC - Murfreesboro

    Murfreesboro, Tennessee, 37129

    Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina, 295724607

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Tennessee Oncology, PLLC - Investigational Drug Services

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology, PLLC - Nashville Elliston Place Plaza Medical Oncology & Hematology Clinic

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology, PLLC - Nashville Saint Thomas West

    Nashville, Tennessee, 37205

    Recruiting

  • Tennessee Oncology, PLLC - Nashville Skyline

    Nashville, Tennessee, 37207

    Recruiting

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

    Recruiting

  • Tennessee Oncology, PLLC - Nashville Southern Hills

    Nashville, Tennessee, 37211

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • Cancer Care Specialists of Illinois

    O'Fallon, Illinois, 62269

    Recruiting

  • OU Health Medical Center

    Oklahoma City, Oklahoma, 73104

    Not yet recruiting

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Not yet recruiting

  • UH Minoff Health Center at Chagrin Highlands

    Orange, Ohio, 44122

    Recruiting

  • UCLA Hematology/Oncology - Pasadena

    Pasadena, California, 91105

    Recruiting

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

    Phoenix, Arizona, 85028

    Recruiting

  • UCLA Hematology/Oncology - Porter Ranch

    Porter Ranch, California, 91326

    Recruiting

  • Northwest Medical Specialties, PLLC

    Puyallup, Washington, 98373

    Recruiting

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

    Recruiting

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

    Recruiting

  • Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)

    Raleigh, North Carolina, 27609

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Richardson/Plano

    Richardson, Texas, 75080

    Recruiting

  • Tennessee Oncology, PLLC - Ringgold

    Ringgold, Georgia, 30736

    Recruiting

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

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

    Rochester, New York, 14642

    Recruiting

  • Highlands Oncology Group, PA

    Rogers, Arkansas, 72758

    Recruiting

  • Blue Ridge Cancer Care

    Salem, Virginia, 24153

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • UCLA Hematology/Oncology - San Luis Obispo

    San Luis Obispo, California, 93401

    Recruiting

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California, 93101

    Recruiting

  • UCLA Hematology/Oncology- Santa Monica

    Santa Monica, California, 90404

    Recruiting

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

    Scottsdale, Arizona, 85260

    Recruiting

  • Integrated Medical Professionals

    Seaford, New York, 11783

    Recruiting

  • Tennessee Oncology, PLLC - Shelbyville

    Shelbyville, Tennessee, 37160

    Recruiting

  • Tennessee Oncology, PLLC - Smyrna

    Smyrna, Tennessee, 37167

    Recruiting

  • Highlands Oncology Group, PA

    Springdale, Arkansas, 72762

    Recruiting

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

    Recruiting

  • Montefiore Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

    Recruiting

  • Montefiore Medical Center- Montefiore Medical Park

    The Bronx, New York, 10461

    Recruiting

  • UCLA Hematology/Oncology - Torrance

    Torrance, California, 90505

    Recruiting

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084

    Recruiting

  • MSK Nassau.

    Uniondale, New York, 11553

    Recruiting

  • UCLA Hematology/Oncology - Santa Clarita

    Valencia, California, 91355

    Recruiting

  • UCLA Hematology/Oncology - Ventura

    Ventura, California, 93003

    Recruiting

  • UCLA Hematology/Oncology - Westlake

    Westlake Village, California, 91361

    Recruiting

  • Blue Ridge Cancer Care

    Wytheville, Virginia, 24382

    Recruiting

Other trials in United States

China22 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Active, not recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Active, not recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Active, not recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Active, not recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Active, not recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Active, not recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

    Active, not recruiting

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, 510635

    Active, not recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Active, not recruiting

  • First Huai'an Hospital Affiliated to Nanjing Medical University

    Huai'an, Jiangsu, 223300

    Active, not recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Active, not recruiting

  • Lanzhou university second hospital

    Lanzhou, Gansu, 730030

    Active, not recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Active, not recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

    Active, not recruiting

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

    Active, not recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Active, not recruiting

  • Suining Central Hospital

    Suining, Sichuan, 629000

    Active, not recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    Active, not recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Active, not recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Active, not recruiting

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

    Active, not recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Active, not recruiting

Other trials in China

Japan14 sites, 14 recruiting

  • Chiba cancer center

    Chiba, Chiba, 260-8717

    Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

    Recruiting

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

    Recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • Keio university hospital

    Shinjuku-ku, Tokyo, 1608582

    Recruiting

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

    Recruiting

Other trials in Japan

Brazil11 sites

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

    Active, not recruiting

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336232

    Active, not recruiting

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

    Active, not recruiting

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

    Porto Alegre, Rio Grande do Sul, 90110-270

    Active, not recruiting

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, São Paulo, 09060-870

    Active, not recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

    Active, not recruiting

  • BP - A Beneficencia Portuguesa de São Paulo

    São Paulo, São Paulo, 01321-001

    Active, not recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

    Active, not recruiting

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01221-020

    Active, not recruiting

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002

    Active, not recruiting

  • Centro de Estudos e Pesquisas Oncologia de Sorocaba (CEPOS)

    Sorocaba, São Paulo, 18030-005

    Active, not recruiting

Other trials in Brazil

France11 sites

  • Centre Hospitalier de la Côte Basque

    Bayonne, Pyrénées-atlantiques, 64109

    Active, not recruiting

  • CHU Besançon

    Besançon, Doubs, 25000

    Active, not recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076

    Active, not recruiting

  • Groupe Vivalto Santé - Clinique Pasteur-Lanroze

    Brest, Brittany Region, 29229

    Active, not recruiting

  • Hopital Henri Mondor

    Créteil, Île-de-France Region, 94010

    Active, not recruiting

  • CHD Vendee

    La Roche-sur-Yon, Vendée, 85000

    Active, not recruiting

  • Centre Leon Berard

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

    Active, not recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69310

    Active, not recruiting

  • Institut Godinot

    Reims, Marne, 51100

    Active, not recruiting

  • Institut Jean Godinot

    Reims, Marne, 51726

    Active, not recruiting

  • Gustave Roussy

    Villejuif, Val-de-marne, 94800

    Active, not recruiting

Other trials in France

Germany10 sites

  • Charité Universitaetsmedizin Berlin

    Berlin, 10117

    Active, not recruiting

  • Düsseldorf University Hospital

    Düsseldorf, 40225

    Active, not recruiting

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075

    Active, not recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Active, not recruiting

  • Heidelberg University Hospital

    Heidelberg, Baden-Wurttemberg, 69120

    Active, not recruiting

  • Universitätsklinikum Schleswig Holstein

    Lübeck, Schleswig-Holstein, 23538

    Active, not recruiting

  • Urologie Neandertal - Praxis Mettmann

    Mettmann, North Rhine-Westphalia, 40822

    Active, not recruiting

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

    Active, not recruiting

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

    Active, not recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

    Active, not recruiting

Other trials in Germany

Italy10 sites

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

    Active, not recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Active, not recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100

    Active, not recruiting

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Piedmont, 10043

    Active, not recruiting

  • Istituto Oncologico Veneto IOV-IRCCS

    Padova, 35128

    Active, not recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, Emilia-Romagna, 48121

    Active, not recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, ROMA, 00144

    Active, not recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano, 20089

    Active, not recruiting

  • ASUIT Trento - Santa Chiara Hospital

    Trento, 38122

    Active, not recruiting

  • Centro Ricerche Cliniche di Verona

    Verona, 37134

    Active, not recruiting

Other trials in Italy

South Korea10 sites

  • Kyungpook National University Chilgok Hospital

    Deagu, Taegu-kwangyǒkshi, 41404

    Active, not recruiting

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

    Active, not recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo, 58128

    Active, not recruiting

  • Chungnam national university hospital

    Junggu, Taejǒn-kwangyǒkshi, 35015

    Active, not recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

    Active, not recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

    Active, not recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

    Active, not recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 07985

    Active, not recruiting

Other trials in South Korea

Turkey (Türkiye)9 sites, 4 recruiting

  • Gulhane Egitim Arastirma Hastanesi

    Ankara, 06010

    Active, not recruiting

  • Memorial Ankara Hastanesi

    Ankara, 06520

    Active, not recruiting

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06620

    Active, not recruiting

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800

    Active, not recruiting

  • Dicle Üniversitesi

    Diyarbakır, 21200

    Recruiting

  • Trakya University Medical Faculty Hospital

    Edirne, 22030

    Recruiting

  • I.E.U. Medical Point Hastanesi

    Izmir, İ̇zmir, 009035575

    Recruiting

  • Dokuz Eylul Universitesi Hastanesi

    Izmir, İ̇zmir, 35340

    Active, not recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Kadıköy, Istanbul, 34722

    Recruiting

Other trials in Turkey (Türkiye)

Canada8 sites

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

    Active, not recruiting

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

    Greenfield Park, Quebec, J4V 2H1

    Active, not recruiting

  • Centre of Applied Urology Research/Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

    Active, not recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

    Active, not recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Active, not recruiting

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4

    Active, not recruiting

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

    Sherbrooke, Quebec, J1H 5N4

    Active, not recruiting

  • Diex Recherche Trois-Rivieres

    Trois-Rivières, Quebec, G9A 4P3

    Active, not recruiting

Other trials in Canada

Poland8 sites

  • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

    Koszalin, 75-581

    Active, not recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o .o.

    Krakow, 31-826

    Active, not recruiting

  • Clinical Best Solutions Sp. z o.o. S.K.

    Lublin, 20-011

    Active, not recruiting

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k

    Poznan, Greater Poland Voivodeship, 61-731

    Active, not recruiting

  • Centrum Medyczne MEDYK

    Rzeszów, 35-326

    Active, not recruiting

  • Zachodniopomorskie Centrum Onkologii

    Szczecin, Zachodniopomorskie Voivodeship, 71-730

    Active, not recruiting

  • POLIMED CLINIC Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 53-329

    Active, not recruiting

  • EMC Instytut Medyczny S.A.

    Wroclaw, 54-239

    Active, not recruiting

Other trials in Poland

United Kingdom8 sites

  • Royal Blackburn Hospital

    Blackburn, Blackburn WITH Darwen, BB2 3HH

    Active, not recruiting

  • Velindre Cancer Centre

    Cardiff, Cardiff [caerdydd Gb-crd], CF14 2TL

    Active, not recruiting

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital

    London, Hammersmith and Fulham, W6 8RF

    Active, not recruiting

  • Royal Marsden Hospital (Chelsea)

    London, Kensington and Chelsea, SW3 6JJ

    Active, not recruiting

  • Maidstone Hospital

    Maidstone, KENT, ME16 9QQ

    Active, not recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Active, not recruiting

  • Derriford Hospital

    Plymouth, Devon, Pl6 8DH

    Active, not recruiting

  • Torbay Hospital

    Torquay, Devon, TQ2 7AA

    Active, not recruiting

Other trials in United Kingdom

Czechia7 sites

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno, South Moravian, 602 00

    Active, not recruiting

  • Masarykuv onkologicky ustav

    Brno, 656 53

    Active, not recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 03

    Active, not recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Active, not recruiting

  • Urocentrum Praha s.r.o.

    Prague, 120 00

    Active, not recruiting

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

    Active, not recruiting

  • Fakultni nemocnice v Motole

    Prague, 150 06

    Active, not recruiting

Other trials in Czechia

Finland7 sites

  • Docrates Syöpäsairaala

    Helsinki, Uusimaa, 00180

    Active, not recruiting

  • Helsinki university hospital

    Helsinki, 00290

    Active, not recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia, 70210

    Active, not recruiting

  • Oulun yliopistollinen sairaala

    Oulu, North Ostrobothnia, 90220

    Active, not recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

    Active, not recruiting

  • Turku University Hospital

    Turku, Southwest Finland, 20520

    Active, not recruiting

  • Vaasan Keskussairaala

    Vaasa, Pohjanmaa, 65130

    Active, not recruiting

Other trials in Finland

Israel7 sites, 1 recruiting

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

    Active, not recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9013102

    Active, not recruiting

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

    Active, not recruiting

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

    Active, not recruiting

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB, 6423906

    Active, not recruiting

  • Yitzhak Shamir Medical Center

    Ẕerifin, Central District, 70300

    Active, not recruiting

Other trials in Israel

Spain7 sites

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Barcelona [barcelona], 08003

    Active, not recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

    Active, not recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Active, not recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Active, not recruiting

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valenciana, Comunitat, 46009

    Active, not recruiting

  • Hospital General Universitario de Valencia

    Valencia, 46014

    Active, not recruiting

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra [pontevedra], 36312

    Active, not recruiting

Other trials in Spain

Argentina6 sites, 1 recruiting

  • Centro Oncologico Korben

    Buenos Aires, C1426ANZ

    Active, not recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN

    Active, not recruiting

  • Investigaciones Oncologicas C. Colon S.A.

    Mar del Plata, Buenos Aires, 7600

    Recruiting

  • Centro de Investigación Pergamino

    Pergamino, Buenos Aires, 2700

    Active, not recruiting

  • Sanatorio Británico

    Rosario, Santa Fe Province, 2000

    Active, not recruiting

  • Instituto de Oncología de Rosario

    Rosario, Santa Fe Province, S2000KZE

    Active, not recruiting

Other trials in Argentina

Australia6 sites

  • ICON Cancer Centre - Kurralta Park

    Kurralta Park, South Australia, 5037

    Active, not recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    Active, not recruiting

  • Orange Health Service

    Orange, New South Wales, 2800

    Active, not recruiting

  • Icon Cancer Centre Chermside

    South Brisbane, Queensland, 4101

    Active, not recruiting

  • Mater Misericordiae Limited Mater Cancer Care Centre

    South Brisbane, Queensland, 4101

    Active, not recruiting

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

    Active, not recruiting

Other trials in Australia

Belgium6 sites

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300

    Active, not recruiting

  • AZ Maria Middelares

    Ghent, Oost-vlaanderen, 9000

    Active, not recruiting

  • AZ. Sint-Lucas

    Ghent, Oost-vlaanderen, 9000

    Active, not recruiting

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

    Active, not recruiting

  • UZ Leuven

    Leuven, Vlaams-brabant, 3000

    Active, not recruiting

  • ZAS Augustinus

    Wilrijk, Antwerpen, 2610

    Active, not recruiting

Other trials in Belgium

New Zealand5 sites

  • Auckland City Hospital

    Auckland, 1023

    Active, not recruiting

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

    Active, not recruiting

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

    Active, not recruiting

  • Palmerston North Hospital

    Palmerston North, 4414

    Active, not recruiting

  • Tauranga Hospital

    Tauranga, Bay of Plenty, 3112

    Active, not recruiting

Other trials in New Zealand

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Active, not recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Active, not recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Active, not recruiting

Other trials in Taiwan

Greece4 sites

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

    Active, not recruiting

  • General Hospital of Athens "G. Gennimatas"

    Athens, 115 27

    Active, not recruiting

  • Metropolitan Hospital

    Neo Faliro, Attica, 18547

    Active, not recruiting

  • Athens Medical Center S.A -European Interbalkan Medical Center

    Thessaloniki, 57001

    Active, not recruiting

Other trials in Greece

Slovakia4 sites

  • Narodny onkologicky ustav

    Bratislava, 833 10

    Active, not recruiting

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 041 91

    Active, not recruiting

  • MILAB, s.r.o., Urologicka ambulancia

    Prešov, 08 001

    Active, not recruiting

  • Privatna urologicka ambulancia, s.r.o.

    Trenčín, 911 01

    Active, not recruiting

Other trials in Slovakia

Bulgaria3 sites

  • MBAL Uni Hospital

    Panagyurishte, Pazardzhik, 4500

    Active, not recruiting

  • Medical Center Futuremeds

    Plovdiv, 4000

    Active, not recruiting

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004

    Active, not recruiting

Other trials in Bulgaria

Netherlands3 sites

  • Reinier de Graaf Ziekenhuis, locatie Delft

    Delft, South Holland, 2625 AD

    Active, not recruiting

  • Tergooiziekenhuizen, locatie Hilversum

    Hilversum, North Holland, 1212 VG

    Active, not recruiting

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

    Active, not recruiting

Other trials in Netherlands

Switzerland1 site

  • Inselspital Bern

    Bern, Canton of Bern, 3010

    Active, not recruiting

Other trials in Switzerland

About this study

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

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.

Read the detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.

This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Being tested
Mevrometostat, Placebo, Enzalutamide
Keywords
Hormone Sensitive Prostate Cancer, Mevrometostat, Metastatic castration sensitive prostate cancer, PF-06821497, EZH2, enhancer of zeste homologue-2, enzalutamide, mCSPC, HSPC, Prostate cancer, castrate sensitive prostate cancer, prostatecancer-study.com, Phase 3, efficacy, safety, pharmacokinetics, pharmacodynamics
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MevrometostatDrug

    Also called PF-06821497

    Oral continuous

  • PlaceboDrug

    Oral continuous

  • EnzalutamideDrug

    Also called Xtandi

    Oral continuous

Study groups in NCT07028853
Study groupRoleWhat they receive
Arm AExperimentalParticipants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Receives: Drug: Mevrometostat; Drug: Enzalutamide
Arm BActive comparatorParticipants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Receives: Drug: Placebo; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression Free Survival (rPFS)

    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.

    Measured: Randomization up to approximately 4 years

Secondary outcomes (18)

  1. Overall survival (OS)

    OS defined as the time from the date of randomization until the date of death due to any cause.

    Measured: Randomization up to approximately 9 years

  2. Objective response in measurable soft tissue disease

    The proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of CR or PR per RECIST v1.1 will be summarized along with the 95% CI.

    Measured: Randomization up to approximately 4 years

  3. Duration of Response (DoR) in measurable soft tissue disease

    The DoR is defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause whichever occurs first.

    Measured: Randomization up to approximately 4 years

  4. Prostate Specific Antigen Response

    The proportion of participants with a 50% decline from baseline in PSA that is confirmed by a second consecutive value at least 21 days later in participants with detectable PSA values at baseline will be calculated for each treatment arm.

    Measured: Randomization up to approximately 4 years

  5. Time to prostate specific antigen (PSA) progression

    Time from the date of randomization to the date of the first PSA progression.

    Measured: Randomization up to approximately 4 years

  6. Time to initiation of antineoplastic therapy

    Time from randomization to first use of new antineoplastic therapy for prostate cancer.

    Measured: Randomization up to approximately 4 years

  7. Time to first symptomatic skeletal event

    Time from randomization to first tumor-related symptomatic bone fracture, surgery or radiotherapy to the bone, and spinal cord compression, whichever occurs first.

    Measured: Randomization up to approximately 4 years

  8. Time from randomization to CRPC

    Time from randomization to the first date of CRPC event.

    Measured: Randomization up to approximately 4 years

  9. Incidence of Adverse Events

    Type, incidence, severity [as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0], seriousness and relationship to study medications of AEs.

    Measured: Randomization up to approximately 5 years

  10. To evaluate the PK of mevrometostat when dosed in combination with enzalutamide

    PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits.

    Measured: Cycle 3 Day 1 to last PK draw at Cycle 5 Day 1 (cycle length is 28 days)

  11. Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)

    Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3.

    Measured: Randomization up to approximately 5 years

  12. Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline in HRQoL (FACT-P total score) will be presented. The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire.

    Measured: Randomization up to approximately 5 years

  13. Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P

    Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as >10 point decrease from baseline and no subsequent observations with a <10 point decrease from baseline FACT-P total score

    Measured: Randomization up to approximately 5 years

  14. Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration

    Change from baseline and time to definitive deterioration in participant-reported prostate cancer specific functioning, and symptoms per EORTC QLQ-PR25

    Measured: Randomization up to approximately 5 years

  15. Change from baseline and time to confirmed deterioration in participant-reported fatigue symptoms per BFI

    Change from baseline and time to confirmed deterioration in participant-reported fatigue symptoms (fatigue severity and fatigue interference) as per BFI.

    Measured: Randomization up to approximately 5 years

  16. Change from baseline in participant-reported general health status per EQ-5D-5L

    Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension.

    Measured: Randomization up to approximately 5 years

  17. To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden

    Evaluation of ctDNA burden at baseline and on study.

    Measured: Baseline up to approximately 4 years

  18. Prostate Specific Antigen Response, Undetectable PSA after Randomization

    The proportion of participants with undetectable PSA values after randomization, in participants with detectable PSA values at baseline, will be calculated for each treatment arm.

    Measured: Randomization up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study start28 Sep 2025
  3. Primary completion12 Sep 2028 (estimated)
  4. Study completion8 Dec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07028853
Sponsor's protocol ID
C2321008
Other IDs
MEVPRO-3, 2024-519369-24-00
Status last verified
Oct 2026
First submitted
15 Apr 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mevrometostat and Enzalutamide in people with Metastatic Castration Sensitive Prostate Cancer (mCSPC) and Hormone Sensitive Prostate Cancer, run by Pfizer at 319 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 319 sites in United States, China, Japan, Brazil, France and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression Free Survival (rPFS) (time frame: Randomization up to approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07028853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in