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

NCT06764485 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CA071-10002024-517422-25U1111-1311-0532
• Study Type: interventional
• Target: 960
• Locations: 25 countries
• Sites: 211

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Prostate cancer; Protein degrader; Protein degradation; Androgen receptor; Castrate resistant prostate cancer; Castration resistant prostate cancer; Hormone resistant; Metastatic hormone resistant prostate cancer; Metastatic castrate resistant prostate cancer; Metastatic castration resistant prostate cancer; BMS-986365; CC-94676; CA071-1000; CA0711000; rechARge; Abiraterone; Docetaxel; Enzalutamide

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

Study Arms (7)

Part 1: Dose 1

EXPERIMENTAL

Drug: BMS-986365

Part 1: Dose 2

EXPERIMENTAL

Drug: BMS-986365

Part 1: Comparator 1

ACTIVE COMPARATOR

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Drug: Enzalutamide; Drug: Abiraterone; Drug: Predinsone/Prednisolone

Part 1: Comparator 2

ACTIVE COMPARATOR

Drug: Docetaxel; Drug: Predinsone/Prednisolone

Part 2: Dose Selected

EXPERIMENTAL

Drug: BMS-986365

Part 2: Comparator 1

ACTIVE COMPARATOR

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Drug: Enzalutamide; Drug: Abiraterone; Drug: Predinsone/Prednisolone

Part 2: Comparator 2

ACTIVE COMPARATOR

Drug: Docetaxel; Drug: Predinsone/Prednisolone

Interventions

BMS-986365 DRUG

Specified dose on specified days

Part 1: Dose 1; Part 1: Dose 2; Part 2: Dose Selected

Enzalutamide DRUG

Specified dose on specified days

Part 1: Comparator 1; Part 2: Comparator 1

Abiraterone DRUG

Specified dose on specified days

Part 1: Comparator 1; Part 2: Comparator 1

Docetaxel DRUG

Specified dose on specified days

Part 1: Comparator 2; Part 2: Comparator 2

Predinsone/Prednisolone DRUG

Specified dose on specified days

Part 1: Comparator 1; Part 1: Comparator 2; Part 2: Comparator 1; Part 2: Comparator 2

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (227)

Local Institution - 0330

Birmingham, Alabama, 35209, United States

Location

Local Institution - 0329

Gilbert, Arizona, 85234, United States

Location

Local Institution - 0370

Anaheim, California, 92801, United States

Location

Local Institution - 0015

La Jolla, California, 92093, United States

Location

Local Institution - 0224

Los Alamitos, California, 90720, United States

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Local Institution - 0016

San Francisco, California, 94115, United States

Location

Local Institution - 0411

San Francisco, California, 94121, United States

Location

Local Institution - 0238

Aurora, Colorado, 80045, United States

Location

Local Institution - 0294

Denver, Colorado, 80218, United States

Location

Local Institution - 0419

Lakewood, Colorado, 80228, United States

Location

Local Institution - 0413

Washington D.C., District of Columbia, 20016, United States

Location

Local Institution - 0426

Lakeland, Florida, 33805, United States

Location

Local Institution - 0077

Athens, Georgia, 30607, United States

Location

Local Institution - 0048

Chicago, Illinois, 60611, United States

Location

Local Institution - 0331

Westwood, Kansas, 66205, United States

Location

Local Institution - 0060

Wichita, Kansas, 67226, United States

Location

Local Institution - 0054

Baltimore, Maryland, 21204, United States

Location

Local Institution - 0019

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0344

Frederick, Maryland, 21702, United States

Location

Local Institution - 0429

Sewell, New Jersey, 08080, United States

Location

Local Institution - 0081

Albuquerque, New Mexico, 87106, United States

Location

Local Institution - 0334

Albuquerque, New Mexico, 87109, United States

Location

Local Institution - 0197

Buffalo, New York, 14263, United States

Location

Local Institution - 0412

Mineola, New York, 11501, United States

Location

Local Institution - 0069

New York, New York, 10016, United States

Location

Local Institution - 0076

New York, New York, 10029, United States

Location

Local Institution - 0085

New York, New York, 10032, United States

Location

Local Institution - 0071

New York, New York, 10065, United States

Location

Local Institution - 0225

Syracuse, New York, 13210, United States

Location

Local Institution - 0056

Columbus, Ohio, 43210, United States

Location

Local Institution - 0067

Portland, Oregon, 97213, United States

Location

Local Institution - 0416

Portland, Oregon, 97225, United States

Location

Local Institution - 0345

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0414

Philadelphia, Pennsylvania, 19107, United States

Location

Local Institution - 0057

Philadelphia, Pennsylvania, 19111, United States

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Local Institution - 0349

Willow Grove, Pennsylvania, 19090, United States

Location

Local Institution - 0055

Charleston, South Carolina, 29425, United States

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Local Institution - 0079

Myrtle Beach, South Carolina, 29572, United States

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Local Institution - 0335

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0018

Austin, Texas, 78705, United States

Location

Local Institution - 0114

Austin, Texas, 78745, United States

Location

Local Institution - 0042

Houston, Texas, 77030, United States

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Local Institution - 0220

Houston, Texas, 77030, United States

Location

Local Institution - 0109

Murray, Utah, 84107, United States

Location

Local Institution - 0050

Charlottesville, Virginia, 22903, United States

Location

Local Institution - 0078

Seattle, Washington, 98109, United States

Location

Local Institution - 0293

Vancouver, Washington, 98684, United States

Location

Local Institution - 0112

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0125

CABA, Buenos Aires, CP1280AEB, Argentina

Location

Local Institution - 0124

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

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Local Institution - 0128

ABB, Buenos Aires F.D., C1199ABB, Argentina

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Local Institution - 0235

Córdoba, Córdoba Province, X5004BAL, Argentina

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Local Institution - 0130

Río Cuarto, Córdoba Province, X5800AEV, Argentina

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Local Institution - 0136

Viedma, R, R8500ACE, Argentina

Location

Local Institution - 0129

Buenos Aires, C1419AHN, Argentina

Location

Local Institution - 0430

Córdoba, 5016, Argentina

Location

Local Institution - 0366

Campbelltown, New South Wales, 2560, Australia

Location

Local Institution - 0359

Darlinghurst, New South Wales, 2010, Australia

Location

Local Institution - 0356

Macquarie University, New South Wales, 2109, Australia

Location

Local Institution - 0360

Port Macquarie, New South Wales, 2444, Australia

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Local Institution - 0355

Wahroonga, New South Wales, 2076, Australia

Location

Local Institution - 0347

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0351

Southport, Queensland, 4215, Australia

Location

Local Institution - 0362

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0358

Elizabeth Vale, South Australia, 5112, Australia

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Local Institution - 0352

Kurralta Park, South Australia, 5037, Australia

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Local Institution - 0354

Hobart, Tasmania, 7000, Australia

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Local Institution - 0363

Heidelberg, Victoria, 3084, Australia

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Local Institution - 0353

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0348

Melbourne, Victoria, 3000, Australia

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Local Institution - 0361

Melbourne, Victoria, 3004, Australia

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Local Institution - 0357

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0369

Krems, Lower Austria, 3500, Austria

Location

Local Institution - 0373

Linz, Upper Austria, 4020, Austria

Location

Local Institution - 0367

Salzburg, 5020, Austria

Location

Local Institution - 0368

Vienna, 1090, Austria

Location

Local Institution - 0025

Belo Horizonte, Minas Gerais, 30110-022, Brazil

Location

Local Institution - 0035

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Local Institution - 0026

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Local Institution - 0395

São Paulo, São Paulo, 01308-060, Brazil

Location

Local Institution - 0031

São Paulo, São Paulo, 01509-010, Brazil

Location

Local Institution - 0304

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Local Institution - 0152

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0151

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 0193

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 0093

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Local Institution - 0149

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0305

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution - 0150

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0164

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0236

Valdivia, Los Ríos Region, 5112129, Chile

Location

Local Institution - 0135

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0132

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0127

Viña del Mar, Valparaiso, 2520598, Chile

Location

Local Institution - 0232

Hefei, Anhui, 230000, China

Location

Local Institution - 0192

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0249

Fuzhou, Fujian, 350001, China

Location

Local Institution - 0213

Xiamen, Fujian, 361003, China

Location

Local Institution - 0226

Guangzhou, Guangdong, 510060, China

Location

Local Institution - 0180

Guangzhou, Guangdong, 510180, China

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Local Institution - 0415

Huizhou, Guangdong, 516001, China

Location

Local Institution - 0417

Changzhou, Jiangsu, 213003, China

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Local Institution - 0233

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0229

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0219

Nanchang, Jiangxi, 330209, China

Location

Local Institution - 0191

Jinan, Shandong, 250117, China

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Local Institution - 0221

Yantai, Shandong, 264099, China

Location

Local Institution - 0214

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0240

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0278

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0283

Chengdu, Sichuan, 610072, China

Location

Local Institution - 0218

Ürümqi, Xinjiang, 830000, China

Location

Local Institution - 0196

Hangzhou, Zhejiang, 310014, China

Location

Local Institution - 0281

Linhai, Zhejiang, 317000, China

Location

Local Institution - 0008

Brno, Brno-město, 656 53, Czechia

Location

Local Institution - 0005

Hradec Králové, Hradec Králové, 500 05, Czechia

Location

Local Institution - 0010

Olomouc, Olomouc Region, 779 00, Czechia

Location

Local Institution - 0009

Prague, Praha 2, 120 00, Czechia

Location

Local Institution - 0004

Prague, Praha 5, 150 06, Czechia

Location

Local Institution - 0006

Prague, 128 08, Czechia

Location

Local Institution - 0243

Copenhagen, Capital Region, 2730, Denmark

Location

Local Institution - 0098

Copenhagen, Capital Region, DK-2100, Denmark

Location

Local Institution - 0396

Aarhus, Central Jutland, 8200, Denmark

Location

Local Institution - 0100

Aalborg, North Denmark, 9000, Denmark

Location

Local Institution - 0096

Kuopio, Northern Savonia, 70210, Finland

Location

Local Institution - 0285

Tampere, Pirkanmaa, 33520, Finland

Location

Local Institution - 0242

Turku, Southwest Finland, 20521, Finland

Location

Local Institution - 0101

Oulu, 90220, Finland

Location

Local Institution - 0167

Nice, Alpes-Maritimes, 06189, France

Location

Local Institution - 0432

Dijon, Côte-d'Or, 21079, France

Location

Local Institution - 0307

Toulouse, Haute-Garonne, 31059, France

Location

Local Institution - 0177

Vandœuvre-lès-Nancy, Lorraine, 54519, France

Location

Local Institution - 0166

Pierre-Bénite, Rhône, 69310, France

Location

Local Institution - 0231

Le Mans, Sarthe, 72000, France

Location

Local Institution - 0179

Villejuif, Val-de-Marne, 94800, France

Location

Local Institution - 0165

Clermont-Ferrand, 63011, France

Location

Local Institution - 0169

Strasbourg, 67098, France

Location

Local Institution - 0421

Nürtingen, Baden-Wurttemberg, 72622, Germany

Location

Local Institution - 0374

München, Bavaria, 81675, Germany

Location

Local Institution - 0371

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0380

Jena, Thuringia, 07747, Germany

Location

Local Institution - 0382

Bonn, 53127, Germany

Location

Local Institution - 0375

Essen, 45122, Germany

Location

Local Institution - 0378

Hamburg, 20246, Germany

Location

Local Institution - 0379

Heidelberg, D-69120, Germany

Location

Local Institution - 0377

Herne, 44625, Germany

Location

Local Institution - 0376

Tübingen, 72076, Germany

Location

Local Institution - 0372

Würzburg, 97080, Germany

Location

Local Institution - 0271

Cork, T12 DC4A, Ireland

Location

Local Institution - 0272

Dublin, D24 NR0A, Ireland

Location

Local Institution - 0273

Dublin, D9, Ireland

Location

Local Institution - 0206

Kfar Saba, Central District, 4428164, Israel

Location

Local Institution - 0208

Petah Tikva, Central District, 4941492, Israel

Location

Local Institution - 0207

Ramat Gan, Central District, 5265601, Israel

Location

Local Institution - 0210

Ẕerifin, Central District, 70300, Israel

Location

Local Institution - 0209

Haifa, Northern District, 3109601, Israel

Location

Local Institution - 0157

Milan, Lombardy, 20133, Italy

Location

Local Institution - 0234

Orbassano, Piedmont, 10043, Italy

Location

Local Institution - 0155

Rome, Roma, 00144, Italy

Location

Local Institution - 0153

Padova, Veneto, 35128, Italy

Location

Local Institution - 0156

Arezzo, 52100, Italy

Location

Local Institution - 0409

Foggia, 71100, Italy

Location

Local Institution - 0160

Naples, 80131, Italy

Location

Local Institution - 0159

Terni, 05100, Italy

Location

Local Institution - 0158

Trento, 38122, Italy

Location

Local Institution - 0121

Mexico City, DIF, 14080, Mexico

Location

Local Institution - 0120

Guadalajara, Jalisco, 44280, Mexico

Location

Local Institution - 0001

Guadalajara, Jalisco, 44670, Mexico

Location

Local Institution - 0002

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0122

Chihuahua City, 31203, Mexico

Location

Local Institution - 0119

Puebla City, 72424, Mexico

Location

Local Institution - 0365

Poznan, Greater Poland Voivodeship, 60-192, Poland

Location

Local Institution - 0346

Wroclaw, Lower Silesian Voivodeship, 53-329, Poland

Location

Local Institution - 0187

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Local Institution - 0190

Opole, Opole Voivodeship, 45-061, Poland

Location

Local Institution - 0186

Gdansk, Pomeranian Voivodeship, 80-219, Poland

Location

Local Institution - 0185

Bytom, Silesian Voivodeship, 41-902, Poland

Location

Local Institution - 0189

Bydgoszcz, 85796, Poland

Location

Local Institution - 0336

Katowice, 40-519, Poland

Location

Local Institution - 0117

Yauco, 00698, Puerto Rico

Location

Local Institution - 0139

Craiova, Dolj, 200542, Romania

Location

Local Institution - 0144

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0145

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0141

Iași, 700483, Romania

Location

Local Institution - 0142

Ploieşti, 100337, Romania

Location

Local Institution - 0381

Prešov, Presov, 080 01, Slovakia

Location

Local Institution - 0389

Goyang-si, Kyǒnggi-do, 10408, South Korea

Location

Local Institution - 0386

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Local Institution - 0385

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Local Institution - 0387

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

Location

Local Institution - 0388

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Local Institution - 0384

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0312

Córdoba, Andalusia, 14004, Spain

Location

Local Institution - 0310

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0311

Sabadell, Barcelona [Barcelona], 08208, Spain

Location

Local Institution - 0325

Barakaldo, Bizkaia, 48903, Spain

Location

Local Institution - 0314

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0315

Barcelona, Catalunya [Cataluña], 08041, Spain

Location

Local Institution - 0319

Lugo, Lugo [Lugo], 27003, Spain

Location

Local Institution - 0321

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Local Institution - 0316

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Local Institution - 0317

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Local Institution - 0323

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Local Institution - 0326

Majadahonda, Madrid, Comunidad de, 28222, Spain

Location

Local Institution - 0406

Pamplona, Navarre, 31009, Spain

Location

Local Institution - 0407

Ourense, Ourense [Orense], 32005, Spain

Location

Local Institution - 0320

Badajoz, 06006, Spain

Location

Local Institution - 0328

Burgos, 09006, Spain

Location

Local Institution - 0318

Granada, 18008, Spain

Location

Local Institution - 0309

Madrid, 28040, Spain

Location

Local Institution - 0327

Málaga, 29016, Spain

Location

Local Institution - 0322

Seville, 41009, Spain

Location

Local Institution - 0313

Seville, 41013, Spain

Location

Local Institution - 0324

Valencia, 46026, Spain

Location

Local Institution - 0099

Lund, Skåne Län [se-12], 22185, Sweden

Location

Local Institution - 0408

Solna, Stockholms Län [se-01], 171 64, Sweden

Location

Local Institution - 0097

Uppsala, Uppsala Län [se-03], 751 85, Sweden

Location

Local Institution - 0095

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

Location

Local Institution - 0398

Taichung, 404332, Taiwan

Location

Local Institution - 0399

Taipei, 10002, Taiwan

Location

Local Institution - 0397

Taipei, 11217, Taiwan

Location

Local Institution - 0420

Taoyuan, 333, Taiwan

Location

Local Institution - 0393

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Local Institution - 0383

Northwood, Hillingdon, HA6 2RN, United Kingdom

Location

Local Institution - 0266

London, London, City of, EC1A 7BE, United Kingdom

Location

Local Institution - 0391

London, Sutton, SM2 5PT, United Kingdom

Location

Local Institution - 0248

Manchester, M20 4BX, United Kingdom

Location

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: 39293515 BACKGROUND

• Nayak 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: 40788283 BACKGROUND

• Chi 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: 40455815 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Prostatic Neoplasms; Bulbo-Spinal Atrophy, X-Linked

Interventions

enzalutamide; abiraterone; Docetaxel; Prednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

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: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

KR (6); AU (4); SE (4); GB (5); BR (5); DE (11); US (48); DK (4); ES (22); SL (1); RO (5); IE (3); CA (9); FR (9); CL (4); CZ (6); IT (9); PL (8); AR (8); TW (4); PR (1); CN (20); FI (4); ME (6); IL (5)