A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

Last updated: April 21, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Docetaxel

Enzalutamide

PF-06821497

Clinical Study ID

NCT06551324
C2321014
2024-511650-50-00
  • Ages > 18
  • Male

Study Summary

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell features.

  • Metastatic disease in bone documented on bone scan, or in soft tissue documented onCT/MRI scan.

  • Progressive disease in the setting of surgical or medical castration with evidenceof disease progression on treatment with abiraterone acetate in the mCSPC setting orfirst line mCRPC setting is required.

  • Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with lifeexpectancy of at least 6 months as assessed by the investigator.

Exclusion

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may make theparticipant inappropriate for the study.

  • Know history of active inflammatory gastrointestinal disease, chronic diarrhea, orprevious gastric resection or lap-band surgery.

  • Clinically significant cardiovascular disease.

  • Known or suspected brain metastasis or active leptomeningeal disease or clinicallysignificant history of seizure.

  • Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy,radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signalinginhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribosepolymerase (PARP) monotherapy or other systemic anti-cancer treatment, with thefollowing exceptions:

  1. Treatment with first-generation antiandrogen agents, if discontinued prior tofirst dose of study intervention.

  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, ordisease progression occurred during treatment or within 3 months of treatmentcompletion.

  • Previous administration with an investigational product within 30 days or 5half-lives preceding the first dose of study intervention (whichever is shorter).

  • Inadequate organ function.

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Docetaxel
Phase: 3
Study Start date:
October 21, 2024
Estimated Completion Date:
October 29, 2028

Connect with a study center

  • Centro de Urología (CDU)

    Caba, Buenos Aires C1120AAT
    Argentina

    Active - Recruiting

  • Hospital Sirio Libanes

    Capital Federal, Buenos Aires C1419AHN
    Argentina

    Active - Recruiting

  • Imagenes Mdq

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires B7600FZO
    Argentina

    Site Not Available

  • Centro Medico Privado CEMAIC

    Capital, Córdoba X5008HHW
    Argentina

    Active - Recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN
    Argentina

    Active - Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

    Buenos Aires, C1431FWO
    Argentina

    Site Not Available

  • IMAXE

    Buenos Aires, C1120
    Argentina

    Active - Recruiting

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, RIO Grande DO SUL 90610-000
    Brazil

    Active - Recruiting

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

    Santo André, SÃO Paulo 09060-650
    Brazil

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz

    Sao Paulo, SÃO Paulo 01327-001
    Brazil

    Site Not Available

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002
    Brazil

    Active - Recruiting

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01221-020
    Brazil

    Active - Recruiting

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Lanzhou university second hospital

    Lanzhou, Gansu 730030
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541199
    China

    Active - Recruiting

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

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu 223300
    China

    Site Not Available

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

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Nantong Tumor Hospital

    Nantong, Jiangsu 226361
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi 710068
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264099
    China

    Site Not Available

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai 200065
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

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

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang 314001
    China

    Active - Recruiting

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang 315010
    China

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  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, Olomoucký KRAJ 779 00
    Czechia

    Site Not Available

  • Multiscan

    Pardubice, Pardubický KRAJ 53203
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    PRague, Praha 10 10034
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4 14059
    Czechia

    Active - Recruiting

  • Nukleární Medicína

    Hradec Králové, 500 05
    Czechia

    Active - Recruiting

  • Radiodiagnostika Pardubice

    Pardubice, 53003
    Czechia

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice, Alpes-maritimes 06189
    France

    Site Not Available

  • Centre Antoine-Lacassagne

    Nice, Alpes-maritimes 06189
    France

    Site Not Available

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, Alsace 67033
    France

    Active - Recruiting

  • CHRU de Brest

    Brest, Finistère 29609
    France

    Site Not Available

  • Oncopole Claudius Regaud

    Toulouse, Haute-garonne 31059
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, Hauts-de-seine 92151
    France

    Active - Recruiting

  • Centre Hospitalier Privé Saint-Grégoire

    Saint Grégoire, Ille-et-vilaine 35760
    France

    Active - Recruiting

  • Institut Jean Godinot

    Reims, Marne 51726
    France

    Site Not Available

  • Centre Leon Berard

    Lyon Cedex08, Rhône-alpes 69373
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Val-de-marne 94800
    France

    Site Not Available

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, 63011
    France

    Site Not Available

  • Studienpraxis Urologie

    Nürtingen, Baden-württemberg 72622
    Germany

    Active - Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-württemberg 72076
    Germany

    Active - Recruiting

  • Urologie Neandertal - Praxis Mettmann

    Mettmann, Nordrhein-westfalen 40822
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, Nordrhein-westfalen 48149
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí 115 28
    Greece

    Site Not Available

  • Athens Medical Center

    Athens, Attikí 151 25
    Greece

    Active - Recruiting

  • Metropolitan General Hospital

    Athens, Attikí 155 62
    Greece

    Active - Recruiting

  • Attikon General University Hospital

    Chaidari, Attikí 124 62
    Greece

    Site Not Available

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

    Meldola, Emilia-romagna 47014
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma, Lazio 00144
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, Roma 00144
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Chiba cancer center

    Chiba-shi, Chiba 260-8717
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido 003-0804
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe, Hyogo 650-0017
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa 232-0024
    Japan

    Active - Recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa 238-8558
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • The University of Osaka Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • Keio university hospital

    Shinjuku-ku, Tokyo 1608582
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo 58128
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang-si, Kyǒnggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 05505
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 07985
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-kwangyǒkshi 41404
    Korea, Republic of

    Active - Recruiting

  • Frisius Medisch Centrum

    Leeuwarden, Fryslân 8934 AD
    Netherlands

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland 6532 SZ
    Netherlands

    Active - Recruiting

  • Tergooiziekenhuizen, locatie Hilversum

    Hilversum, Noord-holland 1212 VG
    Netherlands

    Active - Recruiting

  • Meander Medisch Centrum

    Amersfoort, Utrecht 3813 TZ
    Netherlands

    Active - Recruiting

  • MICS Centrum Medyczne Torun

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

    Kraków, Małopolskie 30-348
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Kraków, Małopolskie 31-826
    Poland

    Site Not Available

  • BEKY - MED, s.r.o.

    Presov, 080 01
    Slovakia

    Active - Recruiting

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

    Presov, 08 001
    Slovakia

    Active - Recruiting

  • Fakultna nemocnica Trnava

    Trnava, 917 02
    Slovakia

    Active - Recruiting

  • Cancercare Langenhoven Drive Oncology Centre

    Port Elizabeth, Eastern CAPE 6045
    South Africa

    Site Not Available

  • Wilgers Oncology Centre

    Pretoria, Gauteng 0081
    South Africa

    Site Not Available

  • TASK Eden

    George, Western CAPE 6529
    South Africa

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña] 08036
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña] 08041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad DE 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad DE 28034
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, 8423
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Södersjukhuset

    Stockholm, Stockholms LÄN [se-01] 11883
    Sweden

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Site Not Available

  • Royal Blackburn Hospital

    Blackburn, Blackburn WITH Darwen BB2 3HH
    United Kingdom

    Active - Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Urology Centers of Alabama

    Homewood, Alabama 35209
    United States

    Active - Recruiting

  • Arizona Urology Specialists (AUS)-Orange Grove

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • Arizona Urology Specialists- Provide ICF for Review Only

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Sutter Santa Rosa

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Bonita Springs, Florida 34135
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Bradenton, Florida 34211
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Cape Coral, Florida 33909
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Port Charlotte, Florida 33980
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34236
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Venice, Florida 34292
    United States

    Active - Recruiting

  • Duly Health and Care

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Duly Health And Care

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • NextStage Clinical Research-Chicago-(04)

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • Duly Health and Care

    Westmont, Illinois 60559
    United States

    Active - Recruiting

  • The University of Louisville, James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • UofL Health Medical Center Northeast

    Louisville, Kentucky 40245
    United States

    Site Not Available

  • AtlantiCare

    Egg Harbor Township, New Jersey 08234
    United States

    Active - Recruiting

  • James J. Peters VA Medical Center

    Bronx, New York 10468
    United States

    Site Not Available

  • Salisbury VA Medical Center

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Keystone Urology Specialists

    Lancaster, Pennsylvania 17604
    United States

    Active - Recruiting

  • AUC Urologists, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Parkway Surgery Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Baptist M&S Imaging (Medical Center)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • USA Clinical Trials

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Site Not Available

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