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
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
3 other identifiers
interventional
960
25 countries
266
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
Typical duration for phase_3
266 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 8, 2025
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 19, 2029
May 6, 2026
May 1, 2026
2.5 years
December 17, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 4 years
Secondary Outcomes (19)
Overall Survival (OS)
Up to 4 years
Recommended dose of BMS-986365 for Part 2
Up to approximately 1.5 years
Progression-free survival (PFS)
Up to 4 years
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Up to 4 years
Time to pain progression (TTPP)
Up to 4 years
- +14 more secondary outcomes
Study Arms (7)
Part 1: Dose 1
EXPERIMENTALPart 1: Dose 2
EXPERIMENTALPart 1: Comparator 1
ACTIVE COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 2
ACTIVE COMPARATORPart 2: Dose Selected
EXPERIMENTALPart 2: Comparator 1
ACTIVE COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 2
ACTIVE COMPARATORInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (282)
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 - 0457
Houston, Texas, 77026, 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
Local Institution - 0415
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
Xinjiang Medical University Cancer Hospital - Urumqi
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
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace, 67033, France
Local Institution - 0432
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
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, 7610793, 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
Related Publications (3)
Rathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ. Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2025 Jan;36(1):76-88. doi: 10.1016/j.annonc.2024.09.005. Epub 2024 Sep 16.
PMID: 39293515BACKGROUNDNayak S, Norris JD, Ammirante M, Rychak E, Wardell SE, Liao D, Toyama B, Kandimalla R, Christoforou A, Tsuji T, Liu K, Tran M, Meiring J, Reiss S, Piccotti JR, Baughman JM, Fontanillo C, Khater M, Mortensen DS, Cathers B, Bence N, Pierce DW, Plantevin-Krenitsky V, Rathkopf D, Hansen JD, Hamann LG, Narla RK, Arora VK, McDonnell DP, Rolfe M, Xu S. Discovery of BMS-986365, a First-in-Class Dual Androgen Receptor Ligand-Directed Degrader and Antagonist, for the Treatment of Advanced Prostate Cancer. Clin Cancer Res. 2026 Jan 6;32(1):224-241. doi: 10.1158/1078-0432.CCR-25-0471.
PMID: 40788283BACKGROUNDChi KN, McKay RR, Sandhu S, Arranz JA, Barthelemy P, Hadaschik B, Matsubara N, Shore ND, Ye D, Cascella T, Irincheeva I, Kreiser S, Thiery-Vuillemin A, Rathkopf DE. rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator's choice in patients with mCRPC. Future Oncol. 2025 Jun;21(14):1771-1777. doi: 10.1080/14796694.2025.2502318. Epub 2025 Jun 2.
PMID: 40455815DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2024
First Posted
January 8, 2025
Study Start
March 13, 2025
Primary Completion (Estimated)
September 12, 2027
Study Completion (Estimated)
January 19, 2029
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See 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