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). (MEVPRO-1)

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
• Intervention / Treatment: Drug: PF-06821497; Drug: Enzalutamide; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1419AHN
    • Asociación de Beneficencia Hospital Sirio Libanés
  • Buenos Aires, Argentina, C1120
    • IMAXE
  • Buenos Aires, Argentina, C1431FWO
    • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1120AAT
      • Centro de Urología (CDU)
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
      • Instituto Alexander Fleming
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clinicas Mar del Plata
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Imagenes Mdq
  • Córdoba Province
    • Capital, Córdoba Province, Argentina, X5008HHW
      • Centro Medico Privado CEMAIC
• Australia
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Centre Wesley
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Melbourne, Victoria, Australia, 3000
      • Peter Maccallum Cancer Centre
• Brazil
  • São Paulo, Brazil, 01221-020
    • Instituto do Cancer Arnaldo Vieira de Carvalho
  • São Paulo, Brazil, 04014-002
    • IBCC - Núcleo de Pesquisa e Ensino
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336232
      • Crio - Centro Regional Integrado de Oncologia
    • Fortaleza, Ceará, Brazil, 60135-237
      • Hospital São Carlos
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas Da Pucrs
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060-650
      • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    • São Paulo, São Paulo, Brazil, 01327-001
      • Hospital Alemao Oswaldo Cruz
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J.E. Child Comprehensive Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Vancouver
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Université de Montréal
• China
  • Anhui
    • Wuhu, Anhui, China, 241001
      • Wannan Medical College Yijishan Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University Nanfang Hospital
  • Guangxi
    • Guilin, Guangxi, China, 541199
      • The Second Affiliated Hospital of Guilin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Huai'an first people's hospital
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Nantong, Jiangsu, China, 226361
      • Nantong Tumor Hospital
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110167
      • The First Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710068
      • Shaanxi Provincial People' Hospital
  • Shandong
    • Yantai, Shandong, China, 264099
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200065
      • Tongji Hospital of Tongji University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Jiaxing, Zhejiang, China, 314001
      • The First hospital of Jiaxing
    • Ningbo, Zhejiang, China, 315010
      • The First Affiliated Hospital of Ningbo University
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Nukleární Medicína
  • Pardubice, Czechia, 53003
    • Radiodiagnostika Pardubice
  • Olomouc Region
    • Olomouc, Olomouc Region, Czechia, 779 00
      • Fakultni nemocnice Olomouc
  • Pardubice Region
    • Pardubice, Pardubice Region, Czechia, 53203
      • Multiscan
  • Praha 10
    • Prague, Praha 10, Czechia, 10034
      • Fakultni nemocnice Kralovske Vinohrady
  • Praha 4
    • Prague, Praha 4, Czechia, 14059
      • Fakultni Thomayerova nemocnice
• France
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06189
      • Centre Antoine Lacassagne
    • Nice, Alpes-maritimes, France, 06189
      • Centre Antoine-Lacassagne
  • Auvergne-Rhône-Alpes
    • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
      • Centre Leon Berard
  • Bas-rhin
    • Strasbourg, Bas-rhin, France, 67091
      • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
  • Finistère
    • Brest, Finistère, France, 29200
      • CHRU de Brest
  • GARD
    • Nîmes, GARD, France, 30029
      • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire
  • Haute-garonne
    • Toulouse, Haute-garonne, France, 31059
      • Oncopole Claudius Regaud
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59020
      • Centre Oscar Lambret
  • Hauts-de-seine
    • Suresnes, Hauts-de-seine, France, 92151
      • Hôpital Foch
  • Ille-et-vilaine
    • Saint-Grégoire, Ille-et-vilaine, France, 35760
      • Centre Hospitalier Prive Saint-Gregoire
  • Marne
    • Reims, Marne, France, 51726
      • Institut Jean Godinot
  • Rhône
    • Pierre-Bénite, Rhône, France, 69310
      • Centre Hospitalier Lyon Sud
  • Val-de-marne
    • Villejuif, Val-de-marne, France, 94800
      • Gustave Roussy
• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Baden-Wurttemberg
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Studienpraxis Urologie
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • North Rhine-Westphalia
    • Mettmann, North Rhine-Westphalia, Germany, 40822
      • Urologie Neandertal - Praxis Mettmann
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitätsklinikum Münster - Albert Schweitzer Campus
• Greece
  • Attikí
    • Athens, Attikí, Greece, 151 25
      • Athens Medical Center
    • Athens, Attikí, Greece, 115 28
      • Alexandra General Hospital of Athens
    • Athens, Attikí, Greece, 155 62
      • Metropolitan General Hospital
    • Chaïdári, Attikí, Greece, 124 62
      • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
• Hungary
  • Győr-Moson-Sopron
    • Győr, Győr-Moson-Sopron, Hungary, 9024
      • Petz Aladar Egyetemi Oktato Korhaz
  • Pest County
    • Budapest, Pest County, Hungary, 1122
      • Orszagos Onkologiai Intezet
• Italy
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
  • Lazio
    • Rome, Lazio, Italy, 00144
      • Istituto Nazionale Tumori Regina Elena
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
    • Yokosuka, Kanagawa, Japan, 238-8558
      • Yokosuka Kyosai Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • The University of Osaka Hospital
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 1608582
      • Keio University Hospital
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius-Wilhelmina Ziekenhuis
  • North Holland
    • Hilversum, North Holland, Netherlands, 1212 VG
      • Tergooi Mc
  • Provincie Friesland
    • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
      • Frisius Medisch Centrum
  • Utrecht
    • Amersfoort, Utrecht, Netherlands, 3813 TZ
      • Meander Medisch Centrum
• Poland
  • Koszalin, Poland, 75-581
    • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
  • Kuyavian-Pomeranian Voivodeship
    • Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland, 86-300
      • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • MICS Centrum Medyczne Torun
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-348
      • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
    • Krakow, Lesser Poland Voivodeship, Poland, 31-826
      • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
      • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
  • Opole Voivodeship
    • Opole, Opole Voivodeship, Poland, 45-061
      • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
• Slovakia
  • Košice, Slovakia, 041 91
    • Vychodoslovensky onkologicky ustav, a.s.
  • Prešov, Slovakia, 08 001
    • MILAB, s.r.o., Urologicka ambulancia
  • Prešov, Slovakia, 080 01
    • BEKY - MED, s.r.o.
  • Trnava, Slovakia, 917 02
    • Fakultna Nemocnica Trnava
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research
• South Korea
  • Jeonranamdo
    • Hwasun, Jeonranamdo, South Korea, 58128
      • Chonnam National University Hwasun Hospital
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, South Korea, 10408
      • National Cancer Center
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 07985
      • Ewha Womans University Mokdong Hospital
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, South Korea, 41404
      • Kyungpook National University Chilgok Hospital
• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Manresa, Spain, 8423
    • Althaia, Xarxa Assistencial Universitària de Manresa
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Institut Catala d'Oncologia - L'Hospitalet
  • Catalunya [cataluña]
    • Barcelona, Catalunya [cataluña], Spain, 08036
      • Hospital Clinic De Barcelona
    • Barcelona, Catalunya [cataluña], Spain, 08041
      • Hospital De La Santa Creu I Sant Pau
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramon y Cajal
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre
• Sweden
  • Stockholms LÄN [se-01]
    • Stockholm, Stockholms LÄN [se-01], Sweden, 11883
      • Södersjukhuset
  • Västra Götalands LÄN [se-14]
    • Gothenburg, Västra Götalands LÄN [se-14], Sweden, 413 45
      • Sahlgrenska Universitetssjukhuset
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100225
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01370
    • Adana City Hospital
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Egitim Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06620
    • Ankara University Health Practice and Research Hospitals
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Health Research and Application Center Gazi Hospital
  • İzmir
    • Cordaleo, İzmir, Turkey (Türkiye), 35575
      • I.E.U. Medical Point Hastanesi
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34722
      • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34899
      • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34010
      • Koc Universitesi Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34668
      • Istanbul Universitesi Cerrahpasa
• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • The Beatson West of Scotland Cancer Centre
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Trust
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital
  • Blackburn WITH Darwen
    • Blackburn, Blackburn WITH Darwen, United Kingdom, BB2 3HH
      • Royal Blackburn Hospital
  • Essex
    • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
      • Mid and South Essex NHS Foundation Trust
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH4 2XU
      • Western General Hospital
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers of Alabama
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer & Research Centers
    • Gilbert, Arizona, United States, 85297
      • Ironwood Cancer & Research Centers
    • Glendale, Arizona, United States, 85306
      • Ironwood Cancer & Research Centers
    • Mesa, Arizona, United States, 85202
      • Ironwood Cancer & Research Centers
    • Mesa, Arizona, United States, 85206
      • Ironwood Cancer & Research Centers
    • Phoenix, Arizona, United States, 85028
      • Ironwood Cancer & Research Centers
    • Scottsdale, Arizona, United States, 85260
      • Ironwood Cancer & Research Centers
  • California
    • Anaheim, California, United States, 92801
      • Los Angeles Cancer Network
    • Berkeley, California, United States, 94702
      • UCSF Cancer Center Berkeley
    • Burlingame, California, United States, 94010
      • UCSF Cancer Center Burlingame
    • Fountain Valley, California, United States, 92708
      • Los Angeles Cancer Network
    • Glendale, California, United States, 91204
      • Los Angeles Cancer Network
    • Glendale, California, United States, 91206
      • Los Angeles Cancer Network
    • Los Angeles, California, United States, 90017
      • Los Angeles Cancer Network
    • Los Angeles, California, United States, 90067
      • Los Angeles Cancer Network
    • Palo Alto, California, United States, 94305
      • Stanford Cancer Center
    • San Francisco, California, United States, 94158
      • UCSF Medical Center at Mission Bay
    • San Francisco, California, United States, 94158
      • UCSF Investigational Drug Pharmacy
    • San Mateo, California, United States, 94402
      • UCSF Cancer Center San Mateo
    • Santa Rosa, California, United States, 95403
      • Sutter Santa Rosa
    • Stanford, California, United States, 94305
      • Stanford Health Care Attention: Investigational Pharmacy
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Florida
    • Aventura, Florida, United States, 33180
      • University of Miami Sylvester Comprehensive Cancer Center - Aventura
    • Bonita Springs, Florida, United States, 34135
      • Florida Cancer Specialists
    • Bradenton, Florida, United States, 34211
      • Florida Cancer Specialists
    • Cape Coral, Florida, United States, 33909
      • Florida Cancer Specialists
    • Coral Gables, Florida, United States, 33146
      • University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
    • Deerfield Beach, Florida, United States, 33442
      • University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
    • Doral, Florida, United States, 33166
      • University of Miami Hospital and Clinics - Doral
    • Fort Myers, Florida, United States, 33905
      • Florida Cancer Specialists
    • Fort Myers, Florida, United States, 33908
      • Florida Cancer Specialists
    • Kendall, Florida, United States, 33176
      • University of Miami Sylvester Comprehensive Cancer Center - Kendall
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics, Sylvester Cancer Center
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics, UHealth Tower
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building
    • N. Venice, Florida, United States, 34275
      • Florida Cancer Specialists
    • Naples, Florida, United States, 34102
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32804
      • AdventHealth Hematology and Oncology
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando Infusion Center
    • Plantation, Florida, United States, 33324
      • University of Miami Sylvester Comprehensive Cancer Center - Plantation
    • Port Charlotte, Florida, United States, 33980
      • Florida Cancer Specialists
    • Sarasota, Florida, United States, 34236
      • Florida Cancer Specialists
  • Illinois
    • Lisle, Illinois, United States, 60532
      • Duly Health and Care
    • Lisle, Illinois, United States, 60532
      • NextStage Clinical Research-Chicago-(04)
    • Westmont, Illinois, United States, 60559
      • Duly Health and Care
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
    • Louisville, Kentucky, United States, 40245
      • UofL Health Medical Center Northeast
    • Louisville, Kentucky, United States, 40202
      • The University of Louisville, James Graham Brown Cancer Center
  • Maine
    • Topsham, Maine, United States, 04086
      • New England Cancer Specialists
    • Westbrook, Maine, United States, 04092
      • New England Cancer Specialists
  • Missouri
    • St Louis, Missouri, United States, 63106
      • VA St. Louis Health Care System
  • New Jersey
    • Cape May Court House, New Jersey, United States, 08210
      • AtlantiCare Health Park - Cape May Court House
    • Egg Harbor, New Jersey, United States, 08234
      • AtlantiCare
  • New York
    • Middletown, New York, United States, 10941
      • Circuit Clinical /Crystal Run Healthcare LLP
    • Middletown, New York, United States, 10941
      • Circuit Clinical
    • Monroe, New York, United States, 10950
      • Crystal Run Healthcare
    • The Bronx, New York, United States, 10468
      • James J. Peters VA Medical Center
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Salisbury VA Medical Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Parkway Surgery Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center, LLC
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Medical Center
    • Myrtle Beach, South Carolina, United States, 29572
      • AUC Urologists, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute, LLC
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Texas
    • San Antonio, Texas, United States, 78229
      • USA Clinical Trials
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center - Montlake
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
• Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
• Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
• Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.

Exclusion Criteria:

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
• Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
• Clinically significant cardiovascular disease.
• Known or suspected brain metastasis or active leptomeningeal disease or clinically significant 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 signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy, CDK4/6 inhibitors, or other systemic anti-cancer treatment, with the following exceptions:

  1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
  3. Use of 5-alpha reductase inhibitors within 28 days of randomization.
• Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
• Inadequate organ function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)	Drug: PF-06821497; 875 mg BID (2 times a day); Other Names: Mevrometostat; Drug: Enzalutamide; 160 mg QD; Other Names: XTANDI
Active Comparator: Arm B; Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days	Drug: Enzalutamide; 160 mg QD; Other Names: XTANDI; Drug: Docetaxel; 75 mg/m2 IV (every 21 days); Other Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)	rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.	Randomization up to approximately 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause.	Randomization up to approximately 4.5 years.
Time to initiation of antineoplastic therapy.	Time from randomization to first use of new antineoplastic therapy.	Randomization up to approximately 4.5 years.
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.	Randomization up to approximately 4.5 years
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 which asks the patient to rate pain at its worst in the last 24 hours.	Randomization up to approximately 4.5 years
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. Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life.	Randomization to approximately 4.5 years
Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Change from baseline in social/family well-being score will be presented. The social/family well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale	Randomization up to approximately 4.5 years
Change from baseline in emotional well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Change from baseline in emotional well-being score will be presented. The emotional well-being score will be calculated based on 6 items in the FACT-P questionnaire; score range 0-24. Each item is rated on a 0 to 4 Likert-type scale	Randomization up to approximately 4.5 years
Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Change from baseline in functioning well-being score will be presented. The functioning well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale	Randomization up to approximately 4.5 years
Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Change from baseline in physical well-being score will be presented. The physical well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale	Randomization to approximately 4.5 years
Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Change from baseline prostate cancer symptoms (PCS) score will be presented. The PCS score will be calculated based on 12 items in the FACT-P questionnaire; score range 0-48. Each item is rated on a 0 to 4 Likert-type scale	Randomization up to approximately 4.5 years
Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (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. The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."	Randomizaton up to approximately 4.5 years
Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)	Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities.	Randomization up to approximately 4.5 years
Overall side effect burden as measured by the FACT- GP5	The FACT-GP5 question assesses overall side effect burden with the following response options "I am bothered by side effects of treatment," is rated on a 5-point scale ranging from "not at all" (0) to "very much" (4) and counts will be presented.	Randomization to approximately 4.5 years
Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"	Defined as the time from randomization to onset of pain progression, which is defined as > 2-point increase from baseline in the score from the BPI-SF Question 3 that is confirmed at the next consecutive assessment > 4 weeks apart or an initial deterioration followed by death before the next assessment	Randomization up to approximately 4.5 years
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	Randomization up to approximately 4.5 years
Time to definitive deterioration in patient-reported physical well-being per FACT-P	Time to definitive deterioration in physical well-being (PWB) per FACT-P is defined as the time from randomization to onset of definitive deterioration in physical well-being, which is defined as ≥3-point	Randomization up to approximately 4.5 years
To evaluate the PK of PF-06821497 when dosed with enzalutamide	PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits.	Cycle 1 (each cycle is 28 days), Day 1 to last PK draw at the end of Cycle 6, Day 1.
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.	Evaluation of ctDNA burden at baseline and on study.	Baseline up to approximately 2 years.
Objective Response (ORR)	The objective response rate is defined as the proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR) per RECIST v1.1.	Randomization up to approximately 2 years.
Duration of Response (DoR) in measurable soft tissue disease	The DoR is defined as 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.	Randomization up to approximately 2 years.
Time to prostate specific antigen (PSA) progression.	Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.	Randomization up to approximately 2 years.
Prostate Specific Antigen Response	Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.	Randomization up to approximately 2 years.
Time to first symptomatic skeletal event	Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first).	Randomization up to approximately 2 years.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): October 29, 2028

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Docetaxel; Safety; Efficacy; Prostate cancer; Relapsed; Open-label; Enzalutamide; refractory; Advanced prostate cancer; Metastatic castrate resistant prostate cancer; castrate resistant prostate cancer; PF-06821497; Enhancer of zeste homolog 2; Hormone resistant; Metastatic hormone resistant prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Recurrence; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; enzalutamide; PF06821497
• Other Study ID Numbers: C2321014; 2024-511650-50-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No