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 (rechARge)

May 1, 2026 updated by: Celgene

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1419AHN
        • Recruiting
        • Asociacion de Beneficencia Hospital Sirio Libanes
        • Contact:
          • Hernan Cutuli, Site 0129
          • Phone Number: 5491157654803
      • Córdoba, Argentina, 5016
        • Recruiting
        • Hospital Privado Universitario De Cordoba
        • Contact:
          • Jeremias Sierra, Site 0430
          • Phone Number: 543514862400
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, CP1280AEB
        • Recruiting
        • Hospital Britanico de Buenos Aires
        • Contact:
          • Ernesto Korbenfeld, Site 0125
          • Phone Number: 54911563819972
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming
        • Contact:
          • Juan Pablo Sade, Site 0124
          • Phone Number: 5432218900
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Federico Cayol, Site 0128
          • Phone Number: 054911555933332
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5004BAL
        • Recruiting
        • Hospital Italiano de Cordoba
        • Contact:
          • Virginia Garcia, Site 0235
          • Phone Number: +5493515054293
      • Río Cuarto, Córdoba Province, Argentina, X5800AEV
        • Not yet recruiting
        • Local Institution - 0130
        • Contact:
          • Site 0130
    • R
      • Viedma, R, Argentina, R8500ACE
        • Recruiting
        • Clinica Viedma S. A
        • Contact:
          • Ruben Kowalyszyn, Site 0136
          • Phone Number: 5492920601693
  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • GenesisCare - Campbelltown
        • Contact:
          • Felicia Roncolato, Site 0366
          • Phone Number: 0246344355
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Anthony Joshua, Site 0359
          • Phone Number: +61293555655
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University
        • Contact:
          • Alison Zhang, Site 0356
          • Phone Number: +61298122956
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • Port Macquarie - Mid North Coast Cancer Institute
        • Contact:
          • Stephen Begbie, Site 0360
          • Phone Number: +61265814053
      • Wahroonga, New South Wales, Australia, 2076
        • Recruiting
        • Sydney Adventist Hospital
        • Contact:
          • Gavin Marx, Site 0355
          • Phone Number: +61290561100
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Recruiting
        • Greenslopes Private Hospital - Gallipoli Medical Research Foundation
        • Contact:
          • Kenneth O'Byrne, Site 0347
          • Phone Number: 0731766505
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Tasman Oncology Research
        • Contact:
          • Andrew Hill, Site 0351
          • Phone Number: +61756132480
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Thean Hsiang TAN, Site 0362
          • Phone Number: +61870742336
      • Elizabeth Vale, South Australia, Australia, 5112
        • Recruiting
        • Lyell McEwin Hospital
        • Contact:
          • Christopher Hocking, Site 0358
          • Phone Number: 08 7117 7265
      • Kurralta Park, South Australia, Australia, 5037
        • Recruiting
        • ICON Cancer Centre - Kurralta Park
        • Contact:
          • Craig Gedye, Site 0352
          • Phone Number: +61884740220
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Icon Cancer Centre Hobart
        • Contact:
          • Louise Nott, Site 0354
          • Phone Number: +61 3 6240 2600
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
          • Andrew Weickhardt, Site 0363
          • Phone Number: +613 9496 5000
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Cabrini Hospital - Malvern
        • Contact:
          • David Pook, Site 0353
          • Phone Number: +61 3 9508 1222
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Shahneen Sandhu, Site 0348
          • Phone Number: +61385595000
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Mark Voskoboynik, Site 0361
          • Phone Number: +61390763129
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • St. John of God Murdoch Hospital
        • Contact:
          • Timothy Slattery, Site 0357
          • Phone Number: +61863230011
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg
        • Contact:
          • Lukas Oberhammer, Site 0367
          • Phone Number: 00435725557213
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universitat Wien
        • Contact:
          • Gero Kramer, Site 0368
          • Phone Number: 4314040026220
    • Lower Austria
      • Krems, Lower Austria, Austria, 3500
        • Recruiting
        • Universitätsklinikum Krems
        • Contact:
          • Sonia Vallet, Site 0369
          • Phone Number: +43273290042555
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen
        • Contact:
          • Ferdinand Luger, Site 0373
          • Phone Number: 4373276774724
  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-022
        • Recruiting
        • Cetus Oncologia - Unidade Belo Horizonte
        • Contact:
          • Elisa Ramos, Site 0025
          • Phone Number: 5531998619660
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Recruiting
        • Liga Norte Riograndense Contra O Cancer
        • Contact:
          • Andrea Gomes, Site 0035
          • Phone Number: 5584991425228
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Recruiting
        • Hospital Moinhos de Vento
        • Contact:
          • Pedro Isaacsson Velho, Site 0026
          • Phone Number: +5551980609999
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center
        • Contact:
          • Jose Augusto Rinck Junior, Site 0031
          • Phone Number: 551121895021
      • São Paulo, São Paulo, Brazil, 01308-060
        • Recruiting
        • Hospital Sirio Libanes
        • Contact:
          • Diogo Bastos, Site 0395
          • Phone Number: 5511992812414
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Recruiting
        • BC Cancer Kelowna
        • Contact:
          • Daygen Finch, Site 0304
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver
        • Contact:
          • Kim Chi, Site 0152
          • Phone Number: 6048776000
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site
        • Contact:
          • Ricardo Rendon, Site 0151
          • Phone Number: 902-473-7969
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
        • Contact:
          • Daniel Khalaf, Site 0193
          • Phone Number: 6048776000 ext676122
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS- saguenay-Lac-Saint-Jean
        • Contact:
          • Jose Luiz Guimaraes, Site 0093
          • Phone Number: 418541-1000
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • April Rose, Site 0149
          • Phone Number: 41694645015190
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
          • Ramy Saleh, Site 0305
          • Phone Number: 5149341934
      • Québec, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
        • Contact:
          • Frederic Pouliot, Site 0150
          • Phone Number: 4185254444
      • Rimouski, Quebec, Canada, G5L 5T1
        • Recruiting
        • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
        • Contact:
          • Samuel Nadeau, Site 0164
          • Phone Number: 4187243000
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia
        • Contact:
          • Maria Herrera, Site 0236
          • Phone Number: +56992195434
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Recruiting
        • Fundación Arturo López Pérez (FALP)
        • Contact:
          • Christian Caglevic, Site 0135
          • Phone Number: 56224457254
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Recruiting
        • Bradfordhill
        • Contact:
          • Mauricio Burotto, Site 0132
          • Phone Number: 56954240753
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • Oncocentro Apys
        • Contact:
          • Alejandro Acevedo Gaete, Site 0127
          • Phone Number: +56992369820
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Second Affiliated hospital of Anhui Medical University
        • Contact:
          • dexin yu, Site 0232
          • Phone Number: 8613705690883
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Zhisong He, Site 0192
          • Phone Number: 13910688432
      • Beijing, Beijing Municipality, China, 100005
        • Not yet recruiting
        • Local Institution - 0168
        • Contact:
          • Site 0168
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Local Institution - 0176
        • Contact:
          • Site 0176
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Not yet recruiting
        • Local Institution - 0237
        • Contact:
          • Site 0237
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Shaoxing Zhu, Site 0249
          • Phone Number: 8618758872716
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The first affiliated hospital of xiamen university
        • Contact:
          • Jinchun Xing, Site 0213
          • Phone Number: 8613806089889
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Kai Yao, Site 0226
          • Phone Number: 15913181211
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
          • Keji Xie, Site 0180
          • Phone Number: 13922231881
      • Huizhou, Guangdong, China, 516001
        • Not yet recruiting
        • Local Institution - 0415
        • Contact:
          • Site 0415
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Withdrawn
        • Local Institution - 0222
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Local Institution - 0211
        • Contact:
          • Site 0211
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Local Institution - 0279
        • Contact:
          • Site 0279
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Local Institution - 0284
        • Contact:
          • Site 0284
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Local Institution - 0216
        • Contact:
          • Site 0216
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Local Institution - 0217
        • Contact:
          • Site 0217
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:
          • Dong Xue, Site 0417
          • Phone Number: +8613775028585
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
          • Ming Chen, Site 0229
          • Phone Number: 13913009977
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
        • Contact:
          • Hongqian Guo, Site 0233
          • Phone Number: 8613605171690
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Local Institution - 0228
        • Contact:
          • Site 0228
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Recruiting
        • The First affiliated hospital of Nanchang University (Xianghu campus)
        • Contact:
          • Bin Fu, Site 0219
          • Phone Number: 13879103861
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • Local Institution - 0198
        • Contact:
          • Site 0198
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Jiasheng Bian, Site 0191
          • Phone Number: +8615954104097
      • Yantai, Shandong, China, 264099
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Jitao Wu, Site 0221
          • Phone Number: +8618953568877
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Dingwei Ye, Site 0214
          • Phone Number: +862164175590-1805
      • Shanghai, Shanghai Municipality, China
        • Withdrawn
        • Local Institution - 0300
      • Shanghai, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Local Institution - 0212
        • Contact:
          • Site 0212
      • Shanghai, Shanghai Municipality, China, 200041
        • Withdrawn
        • Local Institution - 0215
      • Shanghai, Shanghai Municipality, China, 200080
        • Not yet recruiting
        • Local Institution - 0308
        • Contact:
          • Site 0308
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • Local Institution - 0205
        • Contact:
          • Site 0205
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Lu Yang, Site 0278
          • Phone Number: 18980606829
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Jing Liu, Site 0283
          • Phone Number: 17708130563
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Hong Liao, Site 0240
          • Phone Number: 18908178867
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • Xinjiang Medical University Cancer Hospital - Urumqi
        • Contact:
          • Peng Chen, Site 0218
          • Phone Number: 13609982787
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • qi zhang, Site 0196
          • Phone Number: 13858019285
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Local Institution - 0280
        • Contact:
          • Site 0280
      • Linhai, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Mang Ke, Site 0281
          • Phone Number: 13566869198
      • Ningbo, Zhejiang, China, 315010
        • Not yet recruiting
        • Local Institution - 0459
        • Contact:
          • Site 0459
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • Local Institution - 0223
        • Contact:
          • Site 0223
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Contact:
          • Martin Mateju, Site 0006
          • Phone Number: 224966405
    • Beroun
      • Hořovice, Beroun, Czechia, 268 31
        • Withdrawn
        • Local Institution - 0011
    • Brno-město
      • Brno, Brno-město, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav
        • Contact:
          • Jiri Navratil, Site 0008
          • Phone Number: 420543136216
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Contact:
          • Miroslav Hodek, Site 0005
          • Phone Number: +420495832176
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc
        • Contact:
          • Bohuslav Melichar, Site 0010
          • Phone Number: 420588444295
    • Praha 2
      • Prague, Praha 2, Czechia, 120 00
        • Recruiting
        • Urocentrum Praha
        • Contact:
          • Michaela Matouskova, Site 0009
          • Phone Number: 420261083163
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Not yet recruiting
        • Local Institution - 0418
        • Contact:
          • Site 0418
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni Nemocnice Motol a Homolka
        • Contact:
          • Tomas Buchler, Site 0004
          • Phone Number: 420734236410
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital
        • Contact:
          • Rasmus Bisbjerg, Site 0243
          • Phone Number: +4538682090
      • Copenhagen, Capital Region, Denmark, DK-2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Gedske Daugaard, Site 0098
          • Phone Number: 4535454677
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Contact:
          • Simon Buus, Site 0396
          • Phone Number: +4540465291
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd
        • Contact:
          • Mette Moe Kempel, Site 0100
          • Phone Number: 4597661408
  • France
      • Clermont-Ferrand, France, 63011
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
        • Contact:
          • Hakim Mahammedi, Site 0165
          • Phone Number: 33473278131
      • Paris, France, 75014
        • Withdrawn
        • Local Institution - 0178
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Recruiting
        • Centre Antoine-Lacassagne
        • Contact:
          • Delphine Borchiellini, Site 0167
          • Phone Number: +33492031000
    • Alsace
      • Strasbourg, Alsace, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS)
        • Contact:
          • Philippe Barthelemy, Site 0169
          • Phone Number: 33368766767
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • Not yet recruiting
        • Local Institution - 0432
        • Contact:
          • Site 0432
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • Oncopole Claudius Regaud
        • Contact:
          • Loic Mourey, Site 0307
          • Phone Number: 33531155151
    • Ille-et-Vilaine
      • Saint-Grégoire, Ille-et-Vilaine, France, 35760
        • Not yet recruiting
        • Local Institution - 0431
        • Contact:
          • Site 0431
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54519
        • Recruiting
        • Institut de Cancérologie de Lorraine Alexis Vautrin
        • Contact:
          • Vincent Massard, Site 0177
          • Phone Number: 33383598461
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • Denis Maillet, Site 0166
          • Phone Number: +33478864324
    • Sarthe
      • Le Mans, Sarthe, France, 72000
        • Recruiting
        • Clinique Victor Hugo Le Mans
        • Contact:
          • Amandine Ruffier, Site 0231
          • Phone Number: 33243297908
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Ronan Flippot, Site 0179
          • Phone Number: +33142114211
  • Germany
      • Biedenkopf, Germany, 35216
        • Not yet recruiting
        • Local Institution - 0454
        • Contact:
          • Site 0454
      • Bonn, Germany, 53127
        • Recruiting
        • Universitatsklinikum Bonn
        • Contact:
          • Manuel Ritter, Site 0382
          • Phone Number: 0228287-14180
      • Duisburg, Germany, 47169
        • Not yet recruiting
        • Local Institution - 0456
        • Contact:
          • Site 0456
      • Essen, Germany, 45122
        • Recruiting
        • Universitaetsklinikum Essen
        • Contact:
          • Claudia Kesch, Site 0375
          • Phone Number: 020172384969
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Contact:
          • Gunhild Von Amsberg, Site 0378
          • Phone Number: +4915222815585
      • Heidelberg, Germany, D-69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
        • Contact:
          • Stefanie Zschaebitz, Site 0379
          • Phone Number: +49622156-3-9095
      • Herne, Germany, 44625
        • Recruiting
        • Marienhospital Herne
        • Contact:
          • Florian Roghmann, Site 0377
          • Phone Number: 023234990
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Contact:
          • Steffen Rausch, Site 0376
          • Phone Number: 0707129-87235
      • Würzburg, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Hubert Kuebler, Site 0372
          • Phone Number: 4993120132001
    • Baden-Wurttemberg
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Recruiting
        • Studienpraxis Urologie
        • Contact:
          • Tilman Todenhöfer, Site 0421
          • Phone Number: 4915201622246
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Recruiting
        • TUM Klinikum
        • Contact:
          • Margitta Retz, Site 0374
          • Phone Number: 498941402522
    • North Rhine-Westphalia
      • Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
        • Not yet recruiting
        • Local Institution - 0455
        • Contact:
          • Site 0455
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
          • Axel Merseburger, Site 0371
          • Phone Number: +4945150043691
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • Universitatsklinikum Jena
        • Contact:
          • Marc-Oliver Grimm, Site 0380
          • Phone Number: +49(0)36419329901
  • India
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695011
        • Not yet recruiting
        • Local Institution - 0404
        • Contact:
          • Site 0404
    • Maharashtra
      • Navi Mumbai, Maharashtra, India, 410210
        • Not yet recruiting
        • Local Institution - 0401
        • Contact:
          • Site 0401
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Not yet recruiting
        • Local Institution - 0402
        • Contact:
          • Site 0402
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Not yet recruiting
        • Local Institution - 0400
        • Contact:
          • Site 0400
    • West Bengal
      • Kolkata, West Bengal, India, 700156
        • Not yet recruiting
        • Local Institution - 0405
        • Contact:
          • Site 0405
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Recruiting
        • Cork University Hospital
        • Contact:
          • Jack Gleeson, Site 0271
          • Phone Number: 0863313074
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital
        • Contact:
          • Ray Mc Dermott, Site 0272
          • Phone Number: 35314144299
      • Dublin, Ireland, D9
        • Recruiting
        • Beaumont Hospital, Dublin
        • Contact:
          • Min Yuen Teo, Site 0273
          • Phone Number: 35318092010
  • Italy
      • Arezzo, Italy, 52100
        • Recruiting
        • Azienda USL 8 di Arezzo
        • Contact:
          • Alketa Hamzaj, Site 0156
          • Phone Number: 390575255446
      • Catania, Italy, 95126
        • Not yet recruiting
        • Local Institution - 0424
        • Contact:
          • Site 0424
      • Foggia, Italy, 71100
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia
        • Contact:
          • Vincenza Conteduca, Site 0409
          • Phone Number: 390543739100
      • Milan, Italy, 20132
        • Not yet recruiting
        • Local Institution - 0425
        • Contact:
          • Site 0425
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
        • Contact:
          • Sabrina Rossetti, Site 0160
          • Phone Number: 39815903861
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera Santa Maria Terni
        • Contact:
          • Annalisa Guida, Site 0159
          • Phone Number: 390744205631
      • Trento, Italy, 38122
        • Recruiting
        • APSS- Presidio Ospedaliero S. Chiara
        • Contact:
          • Orazio Caffo, Site 0158
          • Phone Number: 390461902121
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Giuseppe Procopio, Site 0157
          • Phone Number: 0390223903028
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Recruiting
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
        • Contact:
          • Consuelo Buttigliero, Site 0234
          • Phone Number: +390119026993
    • Roma
      • Rome, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena
        • Contact:
          • Fabio Calabro, Site 0155
          • Phone Number: 0652666271
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
          • Umberto Basso, Site 0153
          • Phone Number: +39-049-8215953
  • Japan
      • Fukuoka, Japan, 812-8582
        • Not yet recruiting
        • Local Institution - 0439
        • Contact:
          • Site 0439
      • Kashiwa, Japan, 277-8577
        • Not yet recruiting
        • Local Institution - 0434
        • Contact:
          • Site 0434
      • Kobe, Japan, 650-0017
        • Not yet recruiting
        • Local Institution - 0449
        • Contact:
          • Site 0449
      • Kumamoto, Japan, 860-0008
        • Not yet recruiting
        • Local Institution - 0452
        • Contact:
          • Site 0452
      • Osaka, Japan, 541-8567
        • Not yet recruiting
        • Local Institution - 0442
        • Contact:
          • Site 0442
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Not yet recruiting
        • Local Institution - 0451
        • Contact:
          • Site 0451
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Not yet recruiting
        • Local Institution - 0436
        • Contact:
          • Site 0436
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Not yet recruiting
        • Local Institution - 0441
        • Contact:
          • Site 0441
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Not yet recruiting
        • Local Institution - 0435
        • Contact:
          • Site 0435
      • Sapporo, Hokkaido, Japan, 0608648
        • Not yet recruiting
        • Local Institution - 0446
        • Contact:
          • Site 0446
    • Kagawa-ken
      • Kita-Gun, Kagawa-ken, Japan, 7610793
        • Not yet recruiting
        • Local Institution - 0443
        • Contact:
          • Site 0443
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
        • Not yet recruiting
        • Local Institution - 0444
        • Contact:
          • Site 0444
      • Yokohama, Kanagawa, Japan, 232-0024
        • Not yet recruiting
        • Local Institution - 0448
        • Contact:
          • Site 0448
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Not yet recruiting
        • Local Institution - 0437
        • Contact:
          • Site 0437
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Not yet recruiting
        • Local Institution - 0445
        • Contact:
          • Site 0445
      • Koto-ku, Tokyo, Japan, 1358550
        • Not yet recruiting
        • Local Institution - 0440
        • Contact:
          • Site 0440
      • Shinjuku-ku, Tokyo, Japan, 1608582
        • Not yet recruiting
        • Local Institution - 0438
        • Contact:
          • Site 0438
    • Toyama
      • Toyama, Toyama, Japan, 9300194
        • Not yet recruiting
        • Local Institution - 0447
        • Contact:
          • Site 0447
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Not yet recruiting
        • Local Institution - 0450
        • Contact:
          • Site 0450
  • Poland
      • Bydgoszcz, Poland, 85796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka
        • Contact:
          • Bogdan Zurawski, Site 0189
          • Phone Number: 48501446778
      • Katowice, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice
        • Contact:
          • Agata Kachel-Flis, Site 0336
          • Phone Number: +48501714019
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Recruiting
        • Pratia Poznań
        • Contact:
          • Marek Kotlarski, Site 0365
          • Phone Number: 512491461
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-329
        • Recruiting
        • POLIMED
        • Contact:
          • Krzysztof Tupikowski, Site 0346
          • Phone Number: +48660442252
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Recruiting
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
        • Contact:
          • Bartosz Itrych, Site 0187
          • Phone Number: 509665645
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-061
        • Recruiting
        • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
        • Contact:
          • Barbara Radecka, Site 0190
          • Phone Number: 48502313767
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-219
        • Recruiting
        • COPERNICUS PL, Wojewodzkie Centrum Onkologii
        • Contact:
          • Joanna Wojcik-Tomaszewska, Site 0186
          • Phone Number: 48505993747
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Poland, 41-902
        • Recruiting
        • Regional Specialised Hospital No. 4 in Bytom
        • Contact:
          • Ewa Nowakowska-Zajdel, Site 0185
          • Phone Number: +48323964580
  • Puerto Rico
      • Mayagüez, Puerto Rico, 00682
        • Recruiting
        • BRCR Global - Mayagüez
        • Contact:
          • Maryangely Moreno Campa, Site 0117
          • Phone Number: 5614470614
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj
        • Contact:
          • Tudor Ciuleanu, Site 0145
          • Phone Number: 40745646368
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Spitalul Universitar C.F. Cluj-Napoca
        • Contact:
          • Anca Mihailov, Site 0144
          • Phone Number: 40724283983
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie
        • Contact:
          • Teodora Alexa-Stratulat, Site 0141
          • Phone Number: 40757064004
      • Ploieşti, Romania, 100337
        • Recruiting
        • Spitalul Municipal Schuller Ploiești
        • Contact:
          • Nita Amedeia, Site 0142
          • Phone Number: +40728121201
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"
        • Contact:
          • Michael Schenker, Site 0139
          • Phone Number: 40727774974
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Not yet recruiting
        • Local Institution - 0275
        • Contact:
          • Site 0275
      • Bratislava, Slovakia, 83101
        • Not yet recruiting
        • Local Institution - 0201
        • Contact:
          • Site 0201
    • Presov
      • Prešov, Presov, Slovakia, 080 01
        • Recruiting
        • MILAB
        • Contact:
          • Ivan Mincik, Site 0381
          • Phone Number: 421905244256
    • Žilina Region
      • Martin, Žilina Region, Slovakia, 036 01
        • Not yet recruiting
        • Local Institution - 0200
        • Contact:
          • Site 0200
  • South Korea
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center
        • Contact:
          • Jae Young Joung, Site 0389
          • Phone Number: 82319201740
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Sung-Kyu Hong, Site 0386
          • Phone Number: 82-31-787-3878
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Cheol Kwak, Site 0385
          • Phone Number: 82260725189
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Se Hoon Park, Site 0384
          • Phone Number: 82234101767
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Young Deuk Choi, Site 0387
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Jae Lyun Lee, Site 0388
          • Phone Number: 82230105977
  • Spain
      • Badajoz, Spain, 06006
        • Recruiting
        • Hospital Infanta Cristina
        • Contact:
          • Marta Gonzalez Cordero, Site 0320
          • Phone Number: 3492421804048350
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
          • GUILLERMO CRESPO HERRERO, Site 0328
          • Phone Number: 34947281800(35729)
      • Granada, Spain, 18008
        • Recruiting
        • Hospital Vithas La Salud
        • Contact:
          • Pedro Sanchez Rovira, Site 0318
          • Phone Number: 34953220306
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Javier Puente Vazquez, Site 0309
          • Phone Number: 34913303000x7554
      • Málaga, Spain, 29016
        • Not yet recruiting
        • Local Institution - 0327
        • Contact:
          • Site 0327
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Begona Perez Valderrama, Site 0313
          • Phone Number: 34955013068
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • ALBERTO SANCHEZ CAMACHO MEJIAS, Site 0322
          • Phone Number: 955013068
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Regina Girones Sarrio, Site 0324
          • Phone Number: 34961244188
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • MARIA JOSE MENDEZ VIDAL, Site 0312
          • Phone Number: +34957011448
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Joaquin Mateo Valderrama, Site 0310
          • Phone Number: 34689499075
      • Sabadell, Barcelona [Barcelona], Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Contact:
          • Enrique Gallardo Diaz, Site 0311
          • Phone Number: +34656340608
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Recruiting
        • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
        • Contact:
          • Ricardo Fernández Rodríguez, Site 0325
          • Phone Number: +34608901518
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Not yet recruiting
        • Local Institution - 0314
        • Contact:
          • Site 0314
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
          • Jose Pablo Maroto Rey, Site 0315
          • Phone Number: 34935565638
    • Lugo [Lugo]
      • Lugo, Lugo [Lugo], Spain, 27003
        • Recruiting
        • Hospital Lucus Augusti
        • Contact:
          • Sergio Vazquez Estevez, Site 0319
          • Phone Number: 34982296459
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Teresa Alonso Gordoa, Site 0316
          • Phone Number: 34913368263
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Daniel Castellano Gauna, Site 0317
          • Phone Number: 34913908307
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Jose Arranz Arija, Site 0321
          • Phone Number: 34914269393
      • Madrid, Madrid, Comunidad de, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Alvaro Pinto Marin, Site 0323
          • Phone Number: 34912071138
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Aranzazu Gonzalez del Alba, Site 0326
          • Phone Number: +0034871206061
    • Navarre
      • Pamplona, Navarre, Spain, 31009
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Nuria Lainez Milagro, Site 0406
          • Phone Number: 848425233
    • Ourense [Orense]
      • Ourense, Ourense [Orense], Spain, 32005
        • Recruiting
        • Complexo Hospitalario Universitario de Ourense
        • Contact:
          • Ovidio Fernandez Calvo, Site 0407
          • Phone Number: 34649196690
  • Sweden
    • Skåne Län [se-12]
      • Lund, Skåne Län [se-12], Sweden, 22185
        • Recruiting
        • Skånes Universitetssjukhus Lund
        • Contact:
          • Olof Staahl, Site 0099
          • Phone Number: +4646177817
    • Stockholms Län [se-01]
      • Solna, Stockholms Län [se-01], Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
        • Contact:
          • Enrique Castellanos, Site 0408
          • Phone Number: 46851770000
    • Uppsala Län [se-03]
      • Uppsala, Uppsala Län [se-03], Sweden, 751 85
        • Recruiting
        • Akademiska Sjukhuset
        • Contact:
          • INGRIDA VERBIENE, Site 0097
          • Phone Number: +46736869248
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
          • Jon Kindblom, Site 0095
          • Phone Number: 46313427948
  • Taiwan
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Hsi-Chin Wu, Site 0398
          • Phone Number: 886-975681629
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yeong-Shiau Pu, Site 0399
          • Phone Number: 88622312345665238
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Tzu-Chun Wei, Site 0397
          • Phone Number: 886228757519
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Contact:
          • Po-Jung Su, Site 0420
          • Phone Number: +886-975366135
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01370
        • Not yet recruiting
        • Local Institution - 0340
        • Contact:
          • Site 0340
      • Ankara, Turkey (Türkiye), 06010
        • Not yet recruiting
        • Local Institution - 0339
        • Contact:
          • Site 0339
      • Ankara, Turkey (Türkiye), 06620
        • Not yet recruiting
        • Local Institution - 0338
        • Contact:
          • Site 0338
      • Ankara, Turkey (Türkiye), 06800
        • Not yet recruiting
        • Local Institution - 0341
        • Contact:
          • Site 0341
      • Istanbul, Turkey (Türkiye), 34295
        • Not yet recruiting
        • Local Institution - 0337
        • Contact:
          • Site 0337
      • Istanbul, Turkey (Türkiye), 34722
        • Not yet recruiting
        • Local Institution - 0342
        • Contact:
          • Site 0342
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie Nhs Foundation Trust
        • Contact:
          • Andrew Hudson, Site 0248
          • Phone Number: 441614468020
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • The Beatson West of Scotland Cancer Centre
        • Contact:
          • Robert Jones, Site 0393
          • Phone Number: 0141 301 7155
    • Hillingdon
      • Northwood, Hillingdon, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Hospital
        • Contact:
          • anand sharma, Site 0383
          • Phone Number: 0333 332 5470
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Kenrick Ng, Site 0266
          • Phone Number: 02034657562
    • Sutton
      • London, Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton)
        • Contact:
          • Alison Reid, Site 0391
          • Phone Number: 020 8661 3070
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Central Alabama Research
        • Contact:
          • David Mooney, Site 0330
          • Phone Number: 205-502-4700
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • Isaac Bowman, Site 0329
          • Phone Number: 480-256-6444
    • California
      • Anaheim, California, United States, 92801
        • Completed
        • Local Institution - 0370
      • La Jolla, California, United States, 92093
        • Recruiting
        • Moores Cancer Center
        • Contact:
          • Rana McKay, Site 0015
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Cancer and Blood Specialty Clinic
        • Contact:
          • Vu Phan, Site 0224
          • Phone Number: 562-735-0602
      • Los Angeles, California, United States, 90048
        • Withdrawn
        • Local Institution - 0364
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center
        • Contact:
          • Ari Baron, Site 0016
          • Phone Number: 415-923-3012
      • San Francisco, California, United States, 94121
        • Recruiting
        • San Francisco VA Health Care System
        • Contact:
          • Franklin Huang, Site 0411
          • Phone Number: 415-502-0696
      • Santa Rosa, California, United States, 95403
        • Not yet recruiting
        • Local Institution - 0458
        • Contact:
          • Site 0458
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Rocky Mountain Regional VA Medical Center
        • Contact:
          • Jessica McDermott, Site 0238
          • Phone Number: 720-848-0300
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
        • Contact:
          • Manojkumar Bupathi, Site 0294
          • Phone Number: 303-418-7639
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Clinical Research
        • Contact:
          • David Cahn, Site 0419
          • Phone Number: 303-885-9828
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Contact:
          • Adel Mandl, Site 0413
          • Phone Number: 617-820-3433
    • Florida
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Lakeland Regional Cancer Center
        • Contact:
          • Peter Hinds, Site 0426
          • Phone Number: 412-573-9554
    • Georgia
      • Athens, Georgia, United States, 30607
        • Completed
        • Local Institution - 0077
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
          • David VanderWeele, Site 0048
          • Phone Number: 312-926-2413
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center - Westwood
        • Contact:
          • Haoran Li, Site 0331
          • Phone Number: 913-588-6029
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Wichita Urology Group
        • Contact:
          • Timothy Richardson, Site 0060
          • Phone Number: 316-636-6141
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Adel Mandl, Site 0019
          • Phone Number: 617-820-3433
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology
        • Contact:
          • Ronald Tutrone Jr., Site 0054
          • Phone Number: 443-471-5741
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • James M Stockman Cancer Institute
        • Contact:
          • Saro Sarkisian, Site 0344
          • Phone Number: 301-662-8477
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Withdrawn
        • Local Institution - 0104
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Withdrawn
        • Local Institution - 0049
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Thomas Jefferson University, Kennedy Health Alliance
        • Contact:
          • Sheel Patel, Site 0429
          • Phone Number: 215-481-2400
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Comprehensive Cancer Center
        • Contact:
          • Amy Tarnower, Site 0081
          • Phone Number: 505-272-4946
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • New Mexico Oncology Hematology Consultants Ltd.
        • Contact:
          • Jose Avitia, Site 0334
          • Phone Number: 505-842-8171
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
          • Saby George, Site 0197
          • Phone Number: 716-845-8387
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
        • Contact:
          • Mary O'Keeffe, Site 0412
          • Phone Number: 347-724-5409
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Dana Rathkopf, Site 0071
          • Phone Number: 646-422-4379
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Bobby Liaw, Site 0076
          • Phone Number: 212-604-6010
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center
        • Contact:
          • Mary O'Keeffe, Site 0069
          • Phone Number: 347-724-5409
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals - Urology
        • Contact:
          • Christopher Pieczonka, Site 0225
          • Phone Number: 315-478-4185
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
          • Brendan Curti, Site 0067
          • Phone Number: 503-215-5696
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Contact:
          • Brendan Curti, Site 0416
          • Phone Number: 503-215-5696
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Withdrawn
        • Local Institution - 0433
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
          • Fern Anari, Site 0057
          • Phone Number: 215-728-3889
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Clinical Research Institute
        • Contact:
          • Sheel Patel, Site 0414
          • Phone Number: 215-481-2400
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Philadelphia Veterans Affairs Medical Center
        • Contact:
          • Yu-Ning Wong, Site 0345
          • Phone Number: (215)823-5800x206895
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
          • Sheel Patel, Site 0349
          • Phone Number: 215-481-2400
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Hollings Cancer Center
        • Contact:
          • Theodore Gourdin, Site 0055
          • Phone Number: 803-413-1355
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center, LLC
        • Contact:
          • Neal Shore, Site 0079
          • Phone Number: 843-449-1010
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Contact:
          • Joseph Merriman, Site 0335
          • Phone Number: 877-836-6662
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • Urology Austin, PLLC
        • Contact:
          • Brian Mazzarella, Site 0114
          • Phone Number: 336-512-0813
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Central/South Texas
        • Contact:
          • Jeffrey Yorio, Site 0018
          • Phone Number: 512-427-9400
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Andrew Hahn, Site 0042
          • Phone Number: 713-792-5543
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Local Institution - 0220
        • Contact:
          • Site 0220
      • Houston, Texas, United States, 77026
        • Not yet recruiting
        • Local Institution - 0457
        • Contact:
          • Site 0457
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
          • David Gill, Site 0109
          • Phone Number: 913-568-7449
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
          • Robert Dreicer, Site 0050
          • Phone Number: 434-981-5585
      • Richmond, Virginia, United States, 23219
        • Withdrawn
        • Local Institution - 0023
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists, P.C.
        • Contact:
          • Ian Schnadig, Site 0293
          • Phone Number: 503-885-5411
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Kathryn Bylow, Site 0112
          • Phone Number: 000-000-0000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
  • Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
  • Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
  • Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

Exclusion Criteria

  • Participants must not have impaired cardiac function or clinically significant cardiac disease.
  • Participants must not have any brain metastasis.
  • Participants must not have any liver metastasis.
  • Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose 1
Drug: BMS-986365
Specified dose on specified days
Experimental: Part 1: Dose 2
Drug: BMS-986365
Specified dose on specified days
Active Comparator: Part 1: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Drug: Enzalutamide
Specified dose on specified days
Drug: Abiraterone
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days
Active Comparator: Part 1: Comparator 2
Drug: Docetaxel
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days
Experimental: Part 2: Dose Selected
Drug: BMS-986365
Specified dose on specified days
Active Comparator: Part 2: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Drug: Enzalutamide
Specified dose on specified days
Drug: Abiraterone
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days
Active Comparator: Part 2: Comparator 2
Drug: Docetaxel
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 4 years
Up to 4 years
Overall Survival (OS)
Time Frame: Up to 4 years
Up to 4 years
Incidence of adverse events (AEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of serious adverse events (SAEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs leading to discontinuation
Time Frame: Up to 4 years
Up to 4 years
Recommended dose of BMS-986365 for Part 2
Time Frame: Up to approximately 1.5 years
Up to approximately 1.5 years
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Time Frame: Up to 4 years
Up to 4 years
Time to pain progression (TTPP)
Time Frame: Up to 4 years
Up to 4 years
Time to symptomatic progression (TTSP)
Time Frame: Up to 4 years
Up to 4 years
Time to initiation of the first subsequent systemic therapy (TFST)
Time Frame: Up to 4 years
Up to 4 years
Prostate-specific antigen (PSA) response rate
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in Prostate Cancer Subscale (PCS) scores
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in trial outcome index (TOI)
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs leading to dose modifications
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs leading to interruptions
Time Frame: Up to 4 years
Up to 4 years
Electrocardiogram (ECG) findings
Time Frame: Up to 4 years

ECG Findings defined as :

  • Number of Postbaseline Abnormal Corrected QT (QTc) Values
  • Number of abnormal Beats Per Minute (BPM)
Up to 4 years
Incidence of laboratory abnormalities
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

September 12, 2027

Study Completion (Estimated)

January 19, 2029

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA071-1000
  • 2024-517422-25 (Other Identifier: EU CTR)
  • U1111-1311-0532 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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