New hope for men with Hard-to-Treat prostate cancer?

NCT ID NCT06764485

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This phase 3 trial compares a new drug, BMS-986365, against standard treatments (docetaxel or other hormone therapies) in 960 men with metastatic castration-resistant prostate cancer that has stopped responding to hormone therapy. The main goal is to see if the new drug delays cancer growth or improves survival. Participants are randomly assigned to receive either the new drug or a standard therapy chosen by their doctor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BMS-986365
What this could lead to: If successful, this could provide a new treatment option that delays cancer progression and extends survival for men with metastatic castration-resistant prostate cancer.
What could go wrong: This is an early-stage comparison; the new drug may not prove superior to existing therapies. Side effects and tolerability are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 960 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Kennedy disease metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

Local Institution - 0004

Prague, Praha 5, 150 06, Czechia
Local Institution - 0005

Hradec Králové, Hradec Králové, 500 05, Czechia
Local Institution - 0006

Prague, 128 08, Czechia
Local Institution - 0008

Brno, Brno-město, 656 53, Czechia
Local Institution - 0009

Prague, Praha 2, 120 00, Czechia
Local Institution - 0010

Olomouc, Olomouc Region, 779 00, Czechia
Local Institution - 0015

La Jolla, California, 92093, United States
Local Institution - 0016

San Francisco, California, 94115, United States
Local Institution - 0018

Austin, Texas, 78705, United States
Local Institution - 0019

Baltimore, Maryland, 21287, United States
Local Institution - 0025

Belo Horizonte, Minas Gerais, 30110-022, Brazil
Local Institution - 0026

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Local Institution - 0031

São Paulo, São Paulo, 01509-010, Brazil
Local Institution - 0035

Natal, Rio Grande do Norte, 59075-740, Brazil
Local Institution - 0042

Houston, Texas, 77030, United States
Local Institution - 0048

Chicago, Illinois, 60611, United States
Local Institution - 0050

Charlottesville, Virginia, 22903, United States
Local Institution - 0054

Baltimore, Maryland, 21204, United States
Local Institution - 0055

Charleston, South Carolina, 29425, United States
Local Institution - 0056

Columbus, Ohio, 43210, United States
Local Institution - 0057

Philadelphia, Pennsylvania, 19111, United States
Local Institution - 0060

Wichita, Kansas, 67226, United States
Local Institution - 0067

Portland, Oregon, 97213, United States
Local Institution - 0069

New York, New York, 10016, United States
Local Institution - 0071

New York, New York, 10065, United States
Local Institution - 0076

New York, New York, 10029, United States
Local Institution - 0077

Athens, Georgia, 30607, United States
Local Institution - 0078

Seattle, Washington, 98109, United States
Local Institution - 0079

Myrtle Beach, South Carolina, 29572, United States
Local Institution - 0081

Albuquerque, New Mexico, 87106, United States
Local Institution - 0085

New York, New York, 10032, United States
Local Institution - 0093

Chicoutimi, Quebec, G7H 5H6, Canada
Local Institution - 0095

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden
Local Institution - 0097

Uppsala, Uppsala Län [se-03], 751 85, Sweden
Local Institution - 0098

Copenhagen, Capital Region, DK-2100, Denmark
Local Institution - 0099

Lund, Skåne Län [se-12], 22185, Sweden
Local Institution - 0100

Aalborg, North Denmark, 9000, Denmark
Local Institution - 0109

Murray, Utah, 84107, United States
Local Institution - 0112

Milwaukee, Wisconsin, 53226, United States
Local Institution - 0114

Austin, Texas, 78745, United States
Local Institution - 0117

Yauco, 00698, Puerto Rico
Local Institution - 0124

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Local Institution - 0125

CABA, Buenos Aires, CP1280AEB, Argentina
Local Institution - 0127

Viña del Mar, Valparaiso, 2520598, Chile
Local Institution - 0128

ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0129

Buenos Aires, C1419AHN, Argentina
Local Institution - 0130

Río Cuarto, Córdoba Province, X5800AEV, Argentina
Local Institution - 0132

Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0135

Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution - 0136

Viedma, R, R8500ACE, Argentina
Local Institution - 0139

Craiova, Dolj, 200542, Romania
Local Institution - 0141

Iași, 700483, Romania
Local Institution - 0142

Ploieşti, 100337, Romania
Local Institution - 0144

Cluj-Napoca, 400015, Romania
Local Institution - 0145

Cluj-Napoca, 400015, Romania
Local Institution - 0149

Montreal, Quebec, H3T 1E2, Canada
Local Institution - 0150

Québec, Quebec, G1J 1Z4, Canada
Local Institution - 0151

Halifax, Nova Scotia, B3H 2Y9, Canada
Local Institution - 0152

Vancouver, British Columbia, V5Z 4E6, Canada
Local Institution - 0153

Padova, Veneto, 35128, Italy
Local Institution - 0155

Rome, Roma, 00144, Italy
Local Institution - 0156

Arezzo, 52100, Italy
Local Institution - 0157

Milan, Lombardy, 20133, Italy
Local Institution - 0158

Trento, 38122, Italy
Local Institution - 0159

Terni, 05100, Italy
Local Institution - 0160

Naples, 80131, Italy
Local Institution - 0164

Rimouski, Quebec, G5L 5T1, Canada
Local Institution - 0165

Clermont-Ferrand, 63011, France
Local Institution - 0166

Pierre-Bénite, Rhône, 69310, France
Local Institution - 0167

Nice, Alpes-Maritimes, 06189, France
Local Institution - 0169

Strasbourg, 67098, France
Local Institution - 0177

Vandœuvre-lès-Nancy, Lorraine, 54519, France
Local Institution - 0179

Villejuif, Val-de-Marne, 94800, France
Local Institution - 0180

Guangzhou, Guangdong, 510180, China
Local Institution - 0185

Bytom, Silesian Voivodeship, 41-902, Poland
Local Institution - 0186

Gdansk, Pomeranian Voivodeship, 80-219, Poland
Local Institution - 0187

Warsaw, Masovian Voivodeship, 02-507, Poland
Local Institution - 0189

Bydgoszcz, 85796, Poland
Local Institution - 0190

Opole, Opole Voivodeship, 45-061, Poland
Local Institution - 0191

Jinan, Shandong, 250117, China
Local Institution - 0192

Beijing, Beijing Municipality, 100034, China
Local Institution - 0193

Toronto, Ontario, M4N 3M5, Canada
Local Institution - 0196

Hangzhou, Zhejiang, 310014, China
Local Institution - 0197

Buffalo, New York, 14263, United States
Local Institution - 0213

Xiamen, Fujian, 361003, China
Local Institution - 0214

Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0218

Ürümqi, Xinjiang, 830000, China
Local Institution - 0219

Nanchang, Jiangxi, 330209, China
Local Institution - 0220

Houston, Texas, 77030, United States
Local Institution - 0221

Yantai, Shandong, 264099, China
Local Institution - 0224

Los Alamitos, California, 90720, United States
Local Institution - 0225

Syracuse, New York, 13210, United States
Local Institution - 0226

Guangzhou, Guangdong, 510060, China
Local Institution - 0229

Nanjing, Jiangsu, 210009, China
Local Institution - 0231

Le Mans, Sarthe, 72000, France
Local Institution - 0232

Hefei, Anhui, 230000, China
Local Institution - 0233

Nanjing, Jiangsu, 210000, China
Local Institution - 0234

Orbassano, Piedmont, 10043, Italy
Local Institution - 0235

Córdoba, Córdoba Province, X5004BAL, Argentina
Local Institution - 0236

Valdivia, Los Ríos Region, 5112129, Chile
Local Institution - 0238

Aurora, Colorado, 80045, United States
Local Institution - 0240

Chengdu, Sichuan, 610041, China
Local Institution - 0243

Copenhagen, Capital Region, 2730, Denmark
Local Institution - 0248

Manchester, M20 4BX, United Kingdom
Local Institution - 0249

Fuzhou, Fujian, 350001, China
Local Institution - 0266

London, London, City of, EC1A 7BE, United Kingdom
Local Institution - 0271

Cork, T12 DC4A, Ireland
Local Institution - 0272

Dublin, D24 NR0A, Ireland
Local Institution - 0273

Dublin, D9, Ireland
Local Institution - 0278

Chengdu, Sichuan, 610041, China
Local Institution - 0281

Linhai, Zhejiang, 317000, China
Local Institution - 0283

Chengdu, Sichuan, 610072, China
Local Institution - 0293

Vancouver, Washington, 98684, United States
Local Institution - 0294

Denver, Colorado, 80218, United States
Local Institution - 0304

Kelowna, British Columbia, V1Y 5L3, Canada
Local Institution - 0305

Montreal, Quebec, H4A 3J1, Canada
Local Institution - 0307

Toulouse, Haute-Garonne, 31059, France
Local Institution - 0309

Madrid, 28040, Spain
Local Institution - 0310

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0311

Sabadell, Barcelona [Barcelona], 08208, Spain
Local Institution - 0312

Córdoba, Andalusia, 14004, Spain
Local Institution - 0313

Seville, 41013, Spain
Local Institution - 0314

Santander, Cantabria, 39008, Spain
Local Institution - 0315

Barcelona, Catalunya [Cataluña], 08041, Spain
Local Institution - 0316

Madrid, Madrid, Comunidad de, 28034, Spain
Local Institution - 0317

Madrid, Madrid, Comunidad de, 28041, Spain
Local Institution - 0318

Granada, 18008, Spain
Local Institution - 0319

Lugo, Lugo [Lugo], 27003, Spain
Local Institution - 0320

Badajoz, 06006, Spain
Local Institution - 0321

Madrid, Madrid, Comunidad de, 28009, Spain
Local Institution - 0322

Seville, 41009, Spain
Local Institution - 0323

Madrid, Madrid, Comunidad de, 28046, Spain
Local Institution - 0324

Valencia, 46026, Spain
Local Institution - 0325

Barakaldo, Bizkaia, 48903, Spain
Local Institution - 0326

Majadahonda, Madrid, Comunidad de, 28222, Spain
Local Institution - 0327

Málaga, 29016, Spain
Local Institution - 0328

Burgos, 09006, Spain
Local Institution - 0329

Gilbert, Arizona, 85234, United States
Local Institution - 0330

Birmingham, Alabama, 35209, United States
Local Institution - 0331

Westwood, Kansas, 66205, United States
Local Institution - 0334

Albuquerque, New Mexico, 87109, United States
Local Institution - 0335

Nashville, Tennessee, 37203, United States
Local Institution - 0336

Katowice, 40-519, Poland
Local Institution - 0344

Frederick, Maryland, 21702, United States
Local Institution - 0345

Philadelphia, Pennsylvania, 19104, United States
Local Institution - 0346

Wroclaw, Lower Silesian Voivodeship, 53-329, Poland
Local Institution - 0347

Greenslopes, Queensland, 4120, Australia
Local Institution - 0348

Melbourne, Victoria, 3000, Australia
Local Institution - 0349

Willow Grove, Pennsylvania, 19090, United States
Local Institution - 0351

Southport, Queensland, 4215, Australia
Local Institution - 0352

Kurralta Park, South Australia, 5037, Australia
Local Institution - 0353

Malvern, Victoria, 3144, Australia
Local Institution - 0354

Hobart, Tasmania, 7000, Australia
Local Institution - 0355

Wahroonga, New South Wales, 2076, Australia
Local Institution - 0356

Macquarie University, New South Wales, 2109, Australia
Local Institution - 0357

Murdoch, Western Australia, 6150, Australia
Local Institution - 0358

Elizabeth Vale, South Australia, 5112, Australia
Local Institution - 0359

Darlinghurst, New South Wales, 2010, Australia
Local Institution - 0360

Port Macquarie, New South Wales, 2444, Australia
Local Institution - 0361

Melbourne, Victoria, 3004, Australia
Local Institution - 0362

Adelaide, South Australia, 5000, Australia
Local Institution - 0363

Heidelberg, Victoria, 3084, Australia
Local Institution - 0365

Poznan, Greater Poland Voivodeship, 60-192, Poland
Local Institution - 0366

Campbelltown, New South Wales, 2560, Australia
Local Institution - 0367

Salzburg, 5020, Austria
Local Institution - 0368

Vienna, 1090, Austria
Local Institution - 0369

Krems, Lower Austria, 3500, Austria
Local Institution - 0370

Anaheim, California, 92801, United States
Local Institution - 0371

Lübeck, Schleswig-Holstein, 23538, Germany
Local Institution - 0372

Würzburg, 97080, Germany
Local Institution - 0373

Linz, Upper Austria, 4020, Austria
Local Institution - 0374

München, Bavaria, 81675, Germany
Local Institution - 0375

Essen, 45122, Germany
Local Institution - 0376

Tübingen, 72076, Germany
Local Institution - 0377

Herne, 44625, Germany
Local Institution - 0378

Hamburg, 20246, Germany
Local Institution - 0379

Heidelberg, D-69120, Germany
Local Institution - 0380

Jena, Thuringia, 07747, Germany
Local Institution - 0381

Prešov, Presov, 080 01, Slovakia
Local Institution - 0382

Bonn, 53127, Germany
Local Institution - 0383

Northwood, Hillingdon, HA6 2RN, United Kingdom
Local Institution - 0384

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0385

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Local Institution - 0386

Seongnam, Kyǒnggi-do, 13620, South Korea
Local Institution - 0387

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Local Institution - 0388

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Local Institution - 0389

Goyang-si, Kyǒnggi-do, 10408, South Korea
Local Institution - 0391

London, Sutton, SM2 5PT, United Kingdom
Local Institution - 0393

Glasgow, Glasgow City, G12 0YN, United Kingdom
Local Institution - 0395

São Paulo, São Paulo, 01308-060, Brazil
Local Institution - 0396

Aarhus, Central Jutland, 8200, Denmark
Local Institution - 0397

Taipei, 11217, Taiwan
Local Institution - 0398

Taichung, 404332, Taiwan
Local Institution - 0399

Taipei, 10002, Taiwan
Local Institution - 0406

Pamplona, Navarre, 31009, Spain
Local Institution - 0407

Ourense, Ourense [Orense], 32005, Spain
Local Institution - 0408

Solna, Stockholms Län [se-01], 171 64, Sweden
Local Institution - 0409

Foggia, 71100, Italy
Local Institution - 0411

San Francisco, California, 94121, United States
Local Institution - 0412

Mineola, New York, 11501, United States
Local Institution - 0413

Washington D.C., District of Columbia, 20016, United States
Local Institution - 0414

Philadelphia, Pennsylvania, 19107, United States
Local Institution - 0415

Huizhou, Guangdong, 516001, China
Local Institution - 0416

Portland, Oregon, 97225, United States
Local Institution - 0417

Changzhou, Jiangsu, 213003, China
Local Institution - 0419

Lakewood, Colorado, 80228, United States
Local Institution - 0420

Taoyuan, 333, Taiwan
Local Institution - 0421

Nürtingen, Baden-Wurttemberg, 72622, Germany
Local Institution - 0426

Lakeland, Florida, 33805, United States
Local Institution - 0429

Sewell, New Jersey, 08080, United States
Local Institution - 0430

Córdoba, 5016, Argentina
Local Institution - 0432

Dijon, Côte-d'Or, 21079, France

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