A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Start Date
10/22/2024
Completion Date
11/30/2028
Summary
This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
Detailed Description
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting. 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) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PF-06821497
Placebo
Enzalutamide
Conditions
Locations
Ironwood Cancer & Research Centers
Chandler, Arizona 85224
United States
Ironwood Cancer & Research Centers
Gilbert, Arizona 85297
United States
Palo Verde Hematology Oncology
Glendale, Arizona 85304
United States
Ironwood Cancer & Research Centers
Glendale, Arizona 85306
United States
Ironwood Cancer & Research Centers
Goodyear, Arizona 85395
United States
Ironwood Cancer & Research Centers
Mesa, Arizona 85202
United States
Ironwood Cancer & Research Centers
Mesa, Arizona 85206
United States
Ironwood Cancer & Research Centers
Phoenix, Arizona 85028
United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona 85260
United States
Highlands Oncology
Fayetteville, Arkansas 72703
United States
Arkansas Urology - Little Rock
Little Rock, Arkansas 72211
United States
Highlands Oncology
Rogers, Arkansas 72758
United States
Highlands Oncology Group
Springdale, Arkansas 72762
United States
Los Angeles Cancer Network (LACN)
Anaheim, California 92805
United States
Los Angeles Cancer Network (LACN)
Fountain Valley, California 92708
United States
Los Angeles Cancer Network (LACN)
Glendale, California 91204
United States
Los Angeles Cancer Network (LACN)
Glendale, California 91206
United States
Los Angeles Cancer Network (LACN)
Laguna Hills, California 92653
United States
Los Angeles Cancer Network (LACN)
Los Angeles, California 90017
United States
Los Angeles Cancer Network (LACN)
Los Angeles, California 90067
United States
Medical Oncology Associates of San Diego
San Diego, California 92123
United States
Accellacare of Duly
Lisle, Illinois 60532
United States
Duly Health and Care (Bone Scintigraphy)
Lisle, Illinois 60532
United States
Blessing Hospital
Quincy, Illinois 62301
United States
Blessing Physician Services
Quincy, Illinois 62301
United States
Duly Health and Care (CT and MRI)
Westmont, Illinois 60559
United States
Adult & Pediatric Urology, PC
Omaha, Nebraska 68114
United States
CHRISTUS St. Vincent Regional Cancer Center
Santa Fe, New Mexico 87505
United States
Montefiore Medical Center - Medical Park
The Bronx, New York 10461
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
AUC Urologists, LLC
Myrtle Beach, South Carolina 29572
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United States
Grand Strand Medical Center
Myrtle Beach, South Carolina 29572
United States
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United States
USA Clinical Trials
San Antonio, Texas 78229
United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington 98391
United States
Northwest Medical Specialties, PLLC
Federal Way, Washington 98003
United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington 98332
United States
Northwest Medical Specialties, PLLC
Puyallup, Washington 98373
United States
Harborview Medical Center
Seattle, Washington 98104
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
United States
Centro de Urología (CDU)
CABA, Buenos Aires C1120AAT
Argentina
Hospital Sirio Libanes
Capital Federal, Buenos Aires C1419AHN
Argentina
Imagenes Mdq
Mar del Plata, Buenos Aires B7600FZO
Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires B7600FZO
Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province X5008HHW
Argentina
IMAXE
Buenos Aires, C1120
Argentina
Centro Medico Fleischer
Buenos Aires, C1414
Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, X5016KEH
Argentina
Oncocentro Servico Medicos e Hospitalares Ltda
Fortaleza, Ceará 60130-241
Brazil
Hospital São Carlos
Fortaleza, Ceará 60135-237
Brazil
Oncocentro Oncologia
Fortaleza, Ceará 60135-237
Brazil
Instituto D'Or de Pesquisa e Ensino
Fortaleza, Ceará 60170-170
Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará 60336232
Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia 41253-190
Brazil
Clinica Amo - Rio Vermelho
Salvador, Estado de Bahia 41950- 640
Brazil
Clinica Amo - Rio Vermelho
Salvador, Estado de Bahia 41950-640
Brazil
Hospital Sirio Libanes
Brasília, Federal District 70200-730
Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte 59062-000
Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
MedPlex Eixo Norte
Porto Alegre, Rio Grande do Sul 91010-004
Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul 91350-200
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo 14784400
Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo 09060-650
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo 15090000
Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo 01327-001
Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221-020
Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
Brazil
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, 1797
Bulgaria
Prostate Cancer Centre
Calgary, Alberta T2V 1P9
Canada
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia B3H 2Y9
Canada
Lakeridge Health
Oshawa, Ontario L1G 2B9
Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec G7H 5H6
Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec H2X 3E4
Canada
Centro de Investigacion Clinica del Sur
Temuco, Araucania 4781156
Chile
IC La Serena Research
La Serena, Coquimbo Region 1720430
Chile
Clinica Universidad Catolica del Maule
Talca, Maule Region 3465584
Chile
Fundación Arturo López Pérez
Providencia, Santiago Metropolitan 7500836
Chile
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan 7500966
Chile
Oncovida
Providencia, Santiago Metropolitan 7500994
Chile
Centro de Estudios Clínicos SAGA
Santiago, Santiago Metropolitan 7500653
Chile
FALP
Santiago, Santiago Metropolitan 7500921
Chile
Bradfordhill
Santiago, Santiago Metropolitan 8420383
Chile
Oncocentro Apys
Viña del Mar, Valparaiso 2520598
Chile
Wannan Medical College Yijishan Hospital
Wuhu, Anhui 241001
China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality 100021
China
Fujian Cancer Hospital
Fuzhou, Fujian 350014
China
Guangzhou First People's Hospital
Guangzhou, Guangdong 510180
China
The Second Affiliated Hospital of Shantou University School of Medicine
Shantou, Guangdong 515000
China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi 541199
China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan 453003
China
Henan Cancer Hospital
Zhengzhou, Henan 450008
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430022
China
Hunan Cancer Hospital
Changsha, Hunan 410013
China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia 010017
China
Huai'an First People's Hospital
Huai'an, Jiangsu 223300
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
China
Nantong Tumor Hospital
Nantong, Jiangsu 226361
China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
China
Shaanxi Provincial People' Hospital
Xi'an, Shaanxi 710068
China
Shandong Provincial Hospital
Jinan, Shandong 250021
China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266003
China
Weifang People's Hospital
Weifang, Shandong 261041
China
Yantai Yuhuangding Hospital
Yantai, Shandong 264099
China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality 200065
China
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang 315010
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
China
The First Hospital of Jiaxing
Jiaxing, Zhejiang/nanhu 314001
China
Peking University Third Hospital
Beijing, 100191
China
First Affiliated Hospital of China Medical University
Shenyang, 110001
China
The Second Hospital of Tianjin Medical University
Tianjin, 300211
China
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region 708 52
Czechia
Fakultní nemocnice Ostrava
Ostrava - Poruba, Moravian-Silesian Region 708 52
Czechia
Fakultni nemocnice Olomouc
Olomouc, Olomouc Region 779 00
Czechia
Multiscan
Pardubice, Pardubice Region 53203
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10 10034
Czechia
Urocentrum Praha
Prague, Praha 2 120 00
Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4 14059
Czechia
Krajská nemocnice Liberec
Liberec, 460 63
Czechia
Næstved Sygehus
Næstved, Region Sjælland 4700
Denmark
Odense Universitetshospital
Odense, Region Syddanmark 5000
Denmark
Vejle Sygehus
Vejle, Region Syddanmark 7100
Denmark
Oulun yliopistollinen sairaala
Oulu, North Ostrobothnia 90220
Finland
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia 70210
Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa 33520
Finland
Turku University Hospital
Turku, Southwest Finland 20520
Finland
Helsinki university hospital
Helsinki, 00290
Finland
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine 33076
France
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes 69373
France
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg, Bas-rhin 67098
France
CHRU de Brest
Brest, Finistère 29609
France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, Ille-et-vilaine 35760
France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-atlantique 44805
France
Institut Jean Godinot
Reims, Marne 51726
France
Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region 72000
France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône 69310
France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, 63011
France
Institut Godinot
Reims, 51100
France
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg 72622
Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg 72076
Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia 48149
Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany
University Hospital of Patras
Pátrai, Achaḯa 26504
Greece
Alexandra General Hospital of Athens
Athens, Attikí 115 28
Greece
Athens Medical Center
Athens, Attikí 151 25
Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí 124 62
Greece
University General Hospital of Larissa
Larissa, Thessalía 411 10
Greece
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Borsod-Abauj Zemplen county 3526
Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron 9024
Hungary
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Nógrád megye 3100
Hungary
Országos Onkológiai Intézet
Budapest, Pest County 1122
Hungary
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna 47014
Italy
Istituto Nazionale Tumori Regina Elena
Rome, Lazio 00144
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio 00168
Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Milano 20089
Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
Italy
Ospedale San Raffaele
Milan, 20132
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Italy
Azienda Ospedaliera Santa Maria Terni
Terni, 05100
Italy
APSS- Presidio Ospedaliero S. Chiara
Trento, 38122
Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, 37134
Italy
Chiba cancer center
Chiba, Chiba 260-8717
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
Japan
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
Japan
Kobe University Hospital
Kobe, Hyōgo 650-0017
Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken 920-8641
Japan
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa 238-8558
Japan
The University of Osaka Hospital
Suita, Osaka 565-0871
Japan
Keio university hospital
Shinjuku-ku, Tokyo 1608582
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
Japan
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Yamagata University Hospital
Yamagata, 990-9585
Japan
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland 6532 SZ
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, North Holland 1066 CX
Netherlands
Frisius Medisch Centrum
Leeuwarden, Provincie Friesland 8934 AD
Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland
Schiedam, South Holland 3118 JH
Netherlands
Imed Radiology
Tauranga, Bay of Plenty 3112
New Zealand
Tauranga Hospital
Tauranga, Bay of Plenty 3112
New Zealand
Christchurch Hospital
Christchurch, Canterbury 8011
New Zealand
Waikato Hospital
Hamilton, Waikato Region 3204
New Zealand
Auckland City Hospital
Auckland, 1023
New Zealand
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship 30-348
Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship 31-826
Poland
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw, Lower Silesian Voivodeship 50-981
Poland
Clinical Best Solutions
Lublin, Lublin Voivodeship 20-011
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship 02-781
Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
Koszalin, West Pomeranian Voivodeship 75-581
Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, 45-061
Poland
Provita Profamilia
Piotrkow Trybunalski, Łódź Voivodeship 97-300
Poland
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, 851 05
Slovakia
Privatna urologicka ambulancia, s.r.o.
Trenčín, 911 01
Slovakia
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape 6045
South Africa
Wilgers Oncology Centre
Pretoria, Gauteng 0081
South Africa
Wits Clinical Research
Soweto, Gauteng 2013
South Africa
TASK Eden
George, Western Cape 6529
South Africa
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo 58128
South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do 10408
South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 05505
South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
South Korea
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi 41404
South Korea
Chungnam national university hospital
Junggu, Taejǒn-kwangyǒkshi 35015
South Korea
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña] 08908
Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de 28041
Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat 46009
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050
Spain
Södersjukhuset
Stockholm, Stockholms LÄN [se-01] 11883
Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Koç Üniversitesi Hastanesi
Istanbul, İ̇stanbul 34010
Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul 34722
Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, İ̇stanbul 34899
Turkey (Türkiye)
I.E.U. Medical Point Hastanesi
Izmir, İ̇zmir 009035575
Turkey (Türkiye)
Sbü Gülhane Eğitim Ve Araştirma Hastanesi
Ankara, 06010
Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520
Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, 06620
Turkey (Türkiye)
Royal Blackburn Hospital
Blackburn, Blackburn WITH Darwen BB2 3HH
United Kingdom
Mid and South Essex NHS Foundation Trust
Chelmsford, Essex CM1 7ET
United Kingdom
Royal Derby Hospital
Derby, DE22 3NE
United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
United Kingdom