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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
Sponsor: Celgene
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.
Official title: A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
960
Start Date
2025-03-13
Completion Date
2029-01-19
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
BMS-986365
Specified dose on specified days
Enzalutamide
Specified dose on specified days
Abiraterone
Specified dose on specified days
Docetaxel
Specified dose on specified days
Predinsone/Prednisolone
Specified dose on specified days
Locations (227)
Local Institution - 0330
Birmingham, Alabama, United States
Local Institution - 0329
Gilbert, Arizona, United States
Local Institution - 0370
Anaheim, California, United States
Local Institution - 0015
La Jolla, California, United States
Local Institution - 0224
Los Alamitos, California, United States
Local Institution - 0016
San Francisco, California, United States
Local Institution - 0411
San Francisco, California, United States
Local Institution - 0238
Aurora, Colorado, United States
Local Institution - 0294
Denver, Colorado, United States
Local Institution - 0419
Lakewood, Colorado, United States
Local Institution - 0413
Washington D.C., District of Columbia, United States
Local Institution - 0426
Lakeland, Florida, United States
Local Institution - 0077
Athens, Georgia, United States
Local Institution - 0048
Chicago, Illinois, United States
Local Institution - 0331
Westwood, Kansas, United States
Local Institution - 0060
Wichita, Kansas, United States
Local Institution - 0054
Baltimore, Maryland, United States
Local Institution - 0019
Baltimore, Maryland, United States
Local Institution - 0344
Frederick, Maryland, United States
Local Institution - 0429
Sewell, New Jersey, United States
Local Institution - 0081
Albuquerque, New Mexico, United States
Local Institution - 0334
Albuquerque, New Mexico, United States
Local Institution - 0197
Buffalo, New York, United States
Local Institution - 0412
Mineola, New York, United States
Local Institution - 0069
New York, New York, United States
Local Institution - 0076
New York, New York, United States
Local Institution - 0085
New York, New York, United States
Local Institution - 0071
New York, New York, United States
Local Institution - 0225
Syracuse, New York, United States
Local Institution - 0056
Columbus, Ohio, United States
Local Institution - 0067
Portland, Oregon, United States
Local Institution - 0416
Portland, Oregon, United States
Local Institution - 0345
Philadelphia, Pennsylvania, United States
Local Institution - 0414
Philadelphia, Pennsylvania, United States
Local Institution - 0057
Philadelphia, Pennsylvania, United States
Local Institution - 0349
Willow Grove, Pennsylvania, United States
Local Institution - 0055
Charleston, South Carolina, United States
Local Institution - 0079
Myrtle Beach, South Carolina, United States
Local Institution - 0335
Nashville, Tennessee, United States
Local Institution - 0018
Austin, Texas, United States
Local Institution - 0114
Austin, Texas, United States
Local Institution - 0042
Houston, Texas, United States
Local Institution - 0220
Houston, Texas, United States
Local Institution - 0109
Murray, Utah, United States
Local Institution - 0050
Charlottesville, Virginia, United States
Local Institution - 0078
Seattle, Washington, United States
Local Institution - 0293
Vancouver, Washington, United States
Local Institution - 0112
Milwaukee, Wisconsin, United States
Local Institution - 0125
CABA, Buenos Aires, Argentina
Local Institution - 0124
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0128
ABB, Buenos Aires F.D., Argentina
Local Institution - 0235
Córdoba, Córdoba Province, Argentina
Local Institution - 0130
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0136
Viedma, R, Argentina
Local Institution - 0129
Buenos Aires, Argentina
Local Institution - 0430
Córdoba, Argentina
Local Institution - 0366
Campbelltown, New South Wales, Australia
Local Institution - 0359
Darlinghurst, New South Wales, Australia
Local Institution - 0356
Macquarie University, New South Wales, Australia
Local Institution - 0360
Port Macquarie, New South Wales, Australia
Local Institution - 0355
Wahroonga, New South Wales, Australia
Local Institution - 0347
Greenslopes, Queensland, Australia
Local Institution - 0351
Southport, Queensland, Australia
Local Institution - 0362
Adelaide, South Australia, Australia
Local Institution - 0358
Elizabeth Vale, South Australia, Australia
Local Institution - 0352
Kurralta Park, South Australia, Australia
Local Institution - 0354
Hobart, Tasmania, Australia
Local Institution - 0363
Heidelberg, Victoria, Australia
Local Institution - 0353
Malvern, Victoria, Australia
Local Institution - 0348
Melbourne, Victoria, Australia
Local Institution - 0361
Melbourne, Victoria, Australia
Local Institution - 0357
Murdoch, Western Australia, Australia
Local Institution - 0369
Krems, Lower Austria, Austria
Local Institution - 0373
Linz, Upper Austria, Austria
Local Institution - 0367
Salzburg, Austria
Local Institution - 0368
Vienna, Austria
Local Institution - 0025
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0035
Natal, Rio Grande do Norte, Brazil
Local Institution - 0026
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0395
São Paulo, São Paulo, Brazil
Local Institution - 0031
São Paulo, São Paulo, Brazil
Local Institution - 0304
Kelowna, British Columbia, Canada
Local Institution - 0152
Vancouver, British Columbia, Canada
Local Institution - 0151
Halifax, Nova Scotia, Canada
Local Institution - 0193
Toronto, Ontario, Canada
Local Institution - 0093
Chicoutimi, Quebec, Canada
Local Institution - 0149
Montreal, Quebec, Canada
Local Institution - 0305
Montreal, Quebec, Canada
Local Institution - 0150
Québec, Quebec, Canada
Local Institution - 0164
Rimouski, Quebec, Canada
Local Institution - 0236
Valdivia, Los Ríos Region, Chile
Local Institution - 0135
Santiago, Santiago Metropolitan, Chile
Local Institution - 0132
Santiago, Santiago Metropolitan, Chile
Local Institution - 0127
Viña del Mar, Valparaiso, Chile
Local Institution - 0232
Hefei, Anhui, China
Local Institution - 0192
Beijing, Beijing Municipality, China
Local Institution - 0249
Fuzhou, Fujian, China
Local Institution - 0213
Xiamen, Fujian, China
Local Institution - 0226
Guangzhou, Guangdong, China
Local Institution - 0180
Guangzhou, Guangdong, China
Local Institution - 0415
Huizhou, Guangdong, China
Local Institution - 0417
Changzhou, Jiangsu, China
Local Institution - 0233
Nanjing, Jiangsu, China
Local Institution - 0229
Nanjing, Jiangsu, China
Local Institution - 0219
Nanchang, Jiangxi, China
Local Institution - 0191
Jinan, Shandong, China
Local Institution - 0221
Yantai, Shandong, China
Local Institution - 0214
Shanghai, Shanghai Municipality, China
Local Institution - 0240
Chengdu, Sichuan, China
Local Institution - 0278
Chengdu, Sichuan, China
Local Institution - 0283
Chengdu, Sichuan, China
Local Institution - 0218
Ürümqi, Xinjiang, China
Local Institution - 0196
Hangzhou, Zhejiang, China
Local Institution - 0281
Linhai, Zhejiang, China
Local Institution - 0008
Brno, Brno-město, Czechia
Local Institution - 0005
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0010
Olomouc, Olomouc Region, Czechia
Local Institution - 0009
Prague, Praha 2, Czechia
Local Institution - 0004
Prague, Praha 5, Czechia
Local Institution - 0006
Prague, Czechia
Local Institution - 0243
Copenhagen, Capital Region, Denmark
Local Institution - 0098
Copenhagen, Capital Region, Denmark
Local Institution - 0396
Aarhus, Central Jutland, Denmark
Local Institution - 0100
Aalborg, North Denmark, Denmark
Local Institution - 0096
Kuopio, Northern Savonia, Finland
Local Institution - 0285
Tampere, Pirkanmaa, Finland
Local Institution - 0242
Turku, Southwest Finland, Finland
Local Institution - 0101
Oulu, Finland
Local Institution - 0167
Nice, Alpes-Maritimes, France
Local Institution - 0432
Dijon, Côte-d'Or, France
Local Institution - 0307
Toulouse, Haute-Garonne, France
Local Institution - 0177
Vandœuvre-lès-Nancy, Lorraine, France
Local Institution - 0166
Pierre-Bénite, Rhône, France
Local Institution - 0231
Le Mans, Sarthe, France
Local Institution - 0179
Villejuif, Val-de-Marne, France
Local Institution - 0165
Clermont-Ferrand, France
Local Institution - 0169
Strasbourg, France
Local Institution - 0421
Nürtingen, Baden-Wurttemberg, Germany
Local Institution - 0374
München, Bavaria, Germany
Local Institution - 0371
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0380
Jena, Thuringia, Germany
Local Institution - 0382
Bonn, Germany
Local Institution - 0375
Essen, Germany
Local Institution - 0378
Hamburg, Germany
Local Institution - 0379
Heidelberg, Germany
Local Institution - 0377
Herne, Germany
Local Institution - 0376
Tübingen, Germany
Local Institution - 0372
Würzburg, Germany
Local Institution - 0271
Cork, Ireland
Local Institution - 0272
Dublin, Ireland
Local Institution - 0273
Dublin, Ireland
Local Institution - 0206
Kfar Saba, Central District, Israel
Local Institution - 0208
Petah Tikva, Central District, Israel
Local Institution - 0207
Ramat Gan, Central District, Israel
Local Institution - 0210
Ẕerifin, Central District, Israel
Local Institution - 0209
Haifa, Northern District, Israel
Local Institution - 0157
Milan, Lombardy, Italy
Local Institution - 0234
Orbassano, Piedmont, Italy
Local Institution - 0155
Rome, Roma, Italy
Local Institution - 0153
Padova, Veneto, Italy
Local Institution - 0156
Arezzo, Italy
Local Institution - 0409
Foggia, Italy
Local Institution - 0160
Naples, Italy
Local Institution - 0159
Terni, Italy
Local Institution - 0158
Trento, Italy
Local Institution - 0121
Mexico City, DIF, Mexico
Local Institution - 0120
Guadalajara, Jalisco, Mexico
Local Institution - 0001
Guadalajara, Jalisco, Mexico
Local Institution - 0002
Monterrey, Nuevo León, Mexico
Local Institution - 0122
Chihuahua City, Mexico
Local Institution - 0119
Puebla City, Mexico
Local Institution - 0365
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0346
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0187
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0190
Opole, Opole Voivodeship, Poland
Local Institution - 0186
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0185
Bytom, Silesian Voivodeship, Poland
Local Institution - 0189
Bydgoszcz, Poland
Local Institution - 0336
Katowice, Poland
Local Institution - 0117
Yauco, Puerto Rico
Local Institution - 0139
Craiova, Dolj, Romania
Local Institution - 0144
Cluj-Napoca, Romania
Local Institution - 0145
Cluj-Napoca, Romania
Local Institution - 0141
Iași, Romania
Local Institution - 0142
Ploieşti, Romania
Local Institution - 0381
Prešov, Presov, Slovakia
Local Institution - 0389
Goyang-si, Kyǒnggi-do, South Korea
Local Institution - 0386
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0385
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0387
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0388
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0384
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0312
Córdoba, Andalusia, Spain
Local Institution - 0310
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0311
Sabadell, Barcelona [Barcelona], Spain
Local Institution - 0325
Barakaldo, Bizkaia, Spain
Local Institution - 0314
Santander, Cantabria, Spain
Local Institution - 0315
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0319
Lugo, Lugo [Lugo], Spain
Local Institution - 0321
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0316
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0317
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0323
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0326
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0406
Pamplona, Navarre, Spain
Local Institution - 0407
Ourense, Ourense [Orense], Spain
Local Institution - 0320
Badajoz, Spain
Local Institution - 0328
Burgos, Spain
Local Institution - 0318
Granada, Spain
Local Institution - 0309
Madrid, Spain
Local Institution - 0327
Málaga, Spain
Local Institution - 0322
Seville, Spain
Local Institution - 0313
Seville, Spain
Local Institution - 0324
Valencia, Spain
Local Institution - 0099
Lund, Skåne Län [se-12], Sweden
Local Institution - 0408
Solna, Stockholms Län [se-01], Sweden
Local Institution - 0097
Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0095
Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0398
Taichung, Taiwan
Local Institution - 0399
Taipei, Taiwan
Local Institution - 0397
Taipei, Taiwan
Local Institution - 0420
Taoyuan, Taiwan
Local Institution - 0393
Glasgow, Glasgow City, United Kingdom
Local Institution - 0383
Northwood, Hillingdon, United Kingdom
Local Institution - 0266
London, London, City of, United Kingdom
Local Institution - 0391
London, Sutton, United Kingdom
Local Institution - 0248
Manchester, United Kingdom