A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
Start Date
3/13/2025
Completion Date
1/19/2029
Summary
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.
Detailed Description
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide. In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BMS-986365
Enzalutamide
Abiraterone
Docetaxel
Predinsone/Prednisolone
Conditions
Locations
Central Alabama Research
Birmingham, Alabama 35209
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Local Institution - 0370
Anaheim, California 92801
United States
Moores Cancer Center
La Jolla, California 92093
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United States
Local Institution - 0364
Los Angeles, California 90048
United States
California Pacific Medical Center
San Francisco, California 94115
United States
San Francisco VA Health Care System
San Francisco, California 94121
United States
Local Institution - 0458
Santa Rosa, California 95403
United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045
United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80218
United States
Colorado Clinical Research
Lakewood, Colorado 80228
United States
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
United States
Lakeland Regional Cancer Center
Lakeland, Florida 33805
United States
Local Institution - 0077
Athens, Georgia 30607
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United States
Wichita Urology Group
Wichita, Kansas 67226
United States
Chesapeake Urology
Baltimore, Maryland 21204
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
James M Stockman Cancer Institute
Frederick, Maryland 21702
United States
Local Institution - 0104
Minneapolis, Minnesota 55455
United States
Local Institution - 0049
Las Vegas, Nevada 89148
United States
Thomas Jefferson University, Kennedy Health Alliance
Sewell, New Jersey 08080
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87106
United States
New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico 87109
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Local Institution - 0085
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Associated Medical Professionals - Urology
Syracuse, New York 13210
United States
Local Institution - 0056
Columbus, Ohio 43210
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence St. Vincent Medical Center
Portland, Oregon 97225
United States
Local Institution - 0433
Allentown, Pennsylvania 18103
United States
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Hollings Cancer Center
Charleston, South Carolina 29425
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Texas Oncology - Central/South Texas
Austin, Texas 78705
United States
Urology Austin, PLLC
Austin, Texas 78745
United States
Local Institution - 0220
Houston, Texas 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Intermountain Medical Center
Murray, Utah 84107
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22903
United States
Local Institution - 0023
Richmond, Virginia 23219
United States
Local Institution - 0078
Seattle, Washington 98109
United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Hospital Británico de Buenos Aires
CABA, Buenos Aires CP1280AEB
Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D. C1199ABB
Argentina
Hospital Italiano de Córdoba
Córdoba, Córdoba Province X5004BAL
Argentina
Local Institution - 0130
Río Cuarto, Córdoba Province X5800AEV
Argentina
Clinica Viedma S. A
Viedma, R R8500ACE
Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN
Argentina
Hospital Privado Universitario de Córdoba
Córdoba, 5016
Argentina
GenesisCare - Campbelltown
Campbelltown, New South Wales 2560
Australia
St Vincent's Hospital
Darlinghurst, New South Wales 2010
Australia
Macquarie University
Macquarie University, New South Wales 2109
Australia
Port Macquarie - Mid North Coast Cancer Institute
Port Macquarie, New South Wales 2444
Australia
Sydney Adventist Hospital
Wahroonga, New South Wales 2076
Australia
Greenslopes Private Hospital - Gallipoli Medical Research Foundation
Greenslopes, Queensland 4120
Australia
Tasman Oncology Research
Southport, Queensland 4215
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
Australia
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia 5037
Australia
Icon Cancer Centre Hobart
Hobart, Tasmania 7000
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
Cabrini Hospital - Malvern
Malvern, Victoria 3144
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
The Alfred Hospital
Melbourne, Victoria 3004
Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia 6150
Australia
Universitätsklinikum Krems
Krems, Lower Austria 3500
Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria 4020
Austria
Uniklinikum Salzburg
Salzburg, 5020
Austria
Medizinische Universität Wien
Vienna, 1090
Austria
Local Institution - 0039
Vitória, Espírito Santo 29055450
Brazil
Cetus Oncologia - Unidade Belo Horizonte
Belo Horizonte, Minas Gerais 30110-022
Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte 59075-740
Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul 90035-001
Brazil
Hospital Sírio Libanês
São Paulo, São Paulo 01308-060
Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo 01509-010
Brazil
BC Cancer Kelowna
Kelowna, British Columbia V1Y 5L3
Canada
BC Cancer Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia B3H 2Y9
Canada
Sunnybrook Research Institute
Toronto, Ontario M4N 3M5
Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec G7H 5H6
Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec G1J 1Z4
Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
Rimouski, Quebec G5L 5T1
Canada
Oncocentro Valdivia
Valdivia, Los Ríos Region 5112129
Chile
Fundacion Arturo Lopez Perez (FALP)
Santiago, Santiago Metropolitan 7500921
Chile
Bradfordhill
Santiago, Santiago Metropolitan 8420383
Chile
Oncocentro Apys
Viña del Mar, Valparaiso 2520598
Chile
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui 230000
China
Local Institution - 0168
Beijing, Beijing Municipality 100005
China
Peking University First Hospital
Beijing, Beijing Municipality 100034
China
Local Institution - 0176
Beijing, Beijing Municipality 100142
China
Local Institution - 0237
Chongqing, Chongqing Municipality 400030
China
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
China
The First Affiliated hospital of Xiamen University
Xiamen, Fujian 361003
China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
China
Guangzhou First People's Hospital
Guangzhou, Guangdong 510180
China
Huizhou Central People's Hospital
Huizhou, Guangdong 516001
China
Local Institution - 0222
Harbin, Heilongjiang 150081
China
Local Institution - 0211
Zhengzhou, Henan 450003
China
Local Institution - 0279
Zhengzhou, Henan 450008
China
Local Institution - 0284
Wuhan, Hubei 430030
China
Local Institution - 0216
Changsha, Hunan 410008
China
Local Institution - 0217
Changsha, Hunan 410013
China
The First People's Hospital of Changzhou
Changzhou, Jiangsu 213003
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
China
Local Institution - 0228
Nanjing, Jiangsu 210009
China
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
China
The First affiliated hospital of Nanchang University (Xianghu campus)
Nanchang, Jiangxi 330209
China
Local Institution - 0198
Xi'an, Shaanxi 710061
China
Shandong Cancer Hospital
Jinan, Shandong 250117
China
Yantai Yuhuangding Hospital
Yantai, Shandong 264099
China
Local Institution - 0300
Shanghai, Shanghai Municipality 0
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200032
China
Local Institution - 0212
Shanghai, Shanghai Municipality 200032
China
Local Institution - 0215
Shanghai, Shanghai Municipality 200041
China
Local Institution - 0308
Shanghai, Shanghai Municipality 200080
China
Local Institution - 0205
Taiyuan, Shanxi 030001
China
Sichuan Cancer hospital
Chengdu, Sichuan 610041
China
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
China
Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072
China
Local Institution - 0218
Ürümqi, Xinjiang 830000
China
Local Institution - 0181
Hangzhou, Zhejiang 310003
China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 310014
China
Local Institution - 0280
Hangzhou, Zhejiang 310022
China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang 317000
China
Local Institution - 0459
Ningbo, Zhejiang 315010
China
Local Institution - 0223
Wenzhou, Zhejiang 325000
China
Local Institution - 0011
Hořovice, Beroun 268 31
Czechia
Masarykuv onkologicky ustav
Brno, Brno-město 656 53
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové 500 05
Czechia
Fakultni nemocnice Olomouc
Olomouc, Olomouc Region 779 00
Czechia
Urocentrum Praha
Prague, Praha 2 120 00
Czechia
Local Institution - 0418
Prague, Praha 4 14059
Czechia
Fakultni nemocnice Motol a Homolka
Prague, Praha 5 150 06
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Czechia
Herlev and Gentofte Hospital
Copenhagen, Capital Region 2730
Denmark
Rigshospitalet
Copenhagen, Capital Region DK-2100
Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland 8200
Denmark
Aalborg Universitetshospital, Syd
Aalborg, North Denmark 9000
Denmark
Centre Antoine-Lacassagne
Nice, Alpes-Maritimes 06189
France
Centre Georges François Leclerc
Dijon, Côte-d'Or 21079
France
Oncopole Claudius Regaud
Toulouse, Haute-Garonne 31059
France
Local Institution - 0431
Saint-Grégoire, Ille-et-Vilaine 35760
France
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, Lorraine 54519
France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône 69310
France
Clinique Victor Hugo Le Mans
Le Mans, Sarthe 72000
France
Gustave Roussy
Villejuif, Val-de-Marne 94800
France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, 63011
France
Local Institution - 0178
Paris, 75014
France
CHU Strasbourg-Hautepierre
Strasbourg, 67098
France
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg 72622
Germany
TUM Klinikum
München, Bavaria 81675
Germany
Local Institution - 0455
Bergisch Gladbach, North Rhine-Westphalia 51465
Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein 23538
Germany
Universitätsklinikum Jena
Jena, Thuringia 07747
Germany
Local Institution - 0454
Biedenkopf, 35216
Germany
Universitätsklinikum Bonn
Bonn, 53127
Germany
Local Institution - 0456
Duisburg, 47169
Germany
Universitaetsklinikum Essen
Essen, 45122
Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany
Universitaetsklinikum Heidelberg
Heidelberg, D-69120
Germany
Marienhospital Herne
Herne, 44625
Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076
Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Germany
Local Institution - 0404
Thiruvananthapuram, Kerala 695011
India
Local Institution - 0401
Navi Mumbai, Maharashtra 410210
India
Local Institution - 0402
New Delhi, National Capital Territory of Delhi 110029
India
Local Institution - 0400
New Delhi, National Capital Territory of Delhi 110085
India
Local Institution - 0405
Kolkata, West Bengal 700156
India
Cork University Hospital
Cork, T12 DC4A
Ireland
Tallaght University Hospital
Dublin, D24 NR0A
Ireland
Beaumont Hospital, Dublin
Dublin, D9
Ireland
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy 20133
Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont 10043
Italy
Istituto Nazionale Tumori Regina Elena
Rome, Roma 00144
Italy
Istituto Oncologico Veneto IRCCS
Padova, Veneto 35128
Italy
Azienda USL 8 di Arezzo
Arezzo, 52100
Italy
Local Institution - 0424
Catania, 95126
Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia
Foggia, 71100
Italy
Local Institution - 0425
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
Local Institution - 0451
Nagoya, Aichi-ken 466-8560
Japan
Local Institution - 0436
Sakura, Chiba 285-8741
Japan
Local Institution - 0441
Matsuyama, Ehime 791-0280
Japan
Local Institution - 0435
Sapporo, Hokkaido 060-8543
Japan
Local Institution - 0446
Sapporo, Hokkaido 0608648
Japan
Local Institution - 0443
Kita-gun, Kagawa-ken 761-0793
Japan
Local Institution - 0444
Kamakura, Kanagawa 247-8533
Japan
Local Institution - 0448
Yokohama, Kanagawa 232-0024
Japan
Local Institution - 0437
Suita, Osaka 565-0871
Japan
Local Institution - 0445
Bunkyo-ku, Tokyo 1138603
Japan
Local Institution - 0440
Koto-ku, Tokyo 1358550
Japan
Local Institution - 0438
Shinjuku-ku, Tokyo 1608582
Japan
Local Institution - 0447
Toyama, Toyama 9300194
Japan
Local Institution - 0450
Ube, Yamaguchi 755-8505
Japan
Local Institution - 0439
Fukuoka, 812-8582
Japan
Local Institution - 0434
Kashiwa, 277-8577
Japan
Local Institution - 0449
Kobe, 650-0017
Japan
Local Institution - 0452
Kumamoto, 860-0008
Japan
Local Institution - 0442
Osaka, 541-8567
Japan
Pratia Poznań
Poznan, Greater Poland Voivodeship 60-192
Poland
POLIMED
Wroclaw, Lower Silesian Voivodeship 53-329
Poland
Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship 02-507
Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Opole Voivodeship 45-061
Poland
COPERNICUS PL, Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship 80-219
Poland
Regional Specialised Hospital No. 4 in Bytom
Bytom, Silesian Voivodeship 41-902
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, 85796
Poland
Pratia Onkologia Katowice
Katowice, 40-519
Poland
BRCR Global - Mayagüez
Mayagüez, 00682
Puerto Rico
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj 200542
Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Romania
Spitalul Universitar C.F. Cluj-Napoca
Cluj-Napoca, 400015
Romania
Institutul Regional de Oncologie
Iași, 700483
Romania
Spitalul Municipal Schuller Ploiești
Ploieşti, 100337
Romania
MILAB
Prešov, Presov 080 01
Slovakia
Local Institution - 0275
Banská Bystrica, 97517
Slovakia
Local Institution - 0201
Bratislava, 83101
Slovakia
Local Institution - 0200
Martin, Žilina Region 036 01
Slovakia
National Cancer Center
Goyang-si, Kyǒnggi-do 10408
South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do 13620
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
Hospital Universitario Reina Sofia
Córdoba, Andalusia 14004
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
Spain
Hospital Universitari Parc Tauli
Sabadell, Barcelona [Barcelona] 08208
Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, Bizkaia 48903
Spain
Local Institution - 0314
Santander, Cantabria 39008
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña] 08041
Spain
Hospital Lucus Augusti
Lugo, Lugo [Lugo] 27003
Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de 28009
Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de 28041
Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de 28046
Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de 28222
Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre 31009
Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Ourense [Orense] 32005
Spain
Hospital Infanta Cristina
Badajoz, 06006
Spain
Hospital Universitario de Burgos
Burgos, 09006
Spain
Hospital Vithas La Salud
Granada, 18008
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
Local Institution - 0327
Málaga, 29016
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Skånes Universitetssjukhus Lund
Lund, Skåne Län [se-12] 22185
Sweden
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01] 171 64
Sweden
Akademiska sjukhuset
Uppsala, Uppsala Län [se-03] 751 85
Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14] 413 45
Sweden
China Medical University Hospital
Taichung, 404332
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Local Institution - 0340
Adana, 01370
Turkey (Türkiye)
Local Institution - 0339
Ankara, 06010
Turkey (Türkiye)
Local Institution - 0338
Ankara, 06620
Turkey (Türkiye)
Local Institution - 0341
Ankara, 06800
Turkey (Türkiye)
Local Institution - 0337
Istanbul, 34295
Turkey (Türkiye)
Local Institution - 0342
Istanbul, 34722
Turkey (Türkiye)
The Beatson West of Scotland Cancer Centre
Glasgow, Glasgow City G12 0YN
United Kingdom
Mount Vernon Hospital
Northwood, Hillingdon HA6 2RN
United Kingdom
St Bartholomew's Hospital
London, London, City of EC1A 7BE
United Kingdom
Royal Marsden Hospital (Sutton)
London, Sutton SM2 5PT
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom