AzTrials
AzTrials

Metastatic Castration-resistant Prostate CancerPhase 3rechARgeNCT06764485

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

A Phase 3 study testing BMS-986365, Enzalutamide and Abiraterone in people with Metastatic Castration-resistant Prostate Cancer, run by Celgene at 227 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
BMS-986365, Enzalutamide and Abiraterone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
227 sitesin 26 countries
Study dates
13 Mar 2025to 19 Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

227 sites in 26 countries.

227 sites in 26 countries

United States48 sites

  • Local Institution - 0081

    Albuquerque, New Mexico, 87106

  • Local Institution - 0334

    Albuquerque, New Mexico, 87109

  • Local Institution - 0370

    Anaheim, California, 92801

  • Local Institution - 0077

    Athens, Georgia, 30607

  • Local Institution - 0238

    Aurora, Colorado, 80045

  • Local Institution - 0018

    Austin, Texas, 78705

  • Local Institution - 0114

    Austin, Texas, 78745

  • Local Institution - 0054

    Baltimore, Maryland, 21204

  • Local Institution - 0019

    Baltimore, Maryland, 21287

  • Local Institution - 0330

    Birmingham, Alabama, 35209

  • Local Institution - 0197

    Buffalo, New York, 14263

  • Local Institution - 0055

    Charleston, South Carolina, 29425

  • Local Institution - 0050

    Charlottesville, Virginia, 22903

  • Local Institution - 0048

    Chicago, Illinois, 60611

  • Local Institution - 0056

    Columbus, Ohio, 43210

  • Local Institution - 0294

    Denver, Colorado, 80218

  • Local Institution - 0344

    Frederick, Maryland, 21702

  • Local Institution - 0329

    Gilbert, Arizona, 85234

  • Local Institution - 0042

    Houston, Texas, 77030

  • Local Institution - 0220

    Houston, Texas, 77030

  • Local Institution - 0015

    La Jolla, California, 92093

  • Local Institution - 0426

    Lakeland, Florida, 33805

  • Local Institution - 0419

    Lakewood, Colorado, 80228

  • Local Institution - 0224

    Los Alamitos, California, 90720

  • Local Institution - 0112

    Milwaukee, Wisconsin, 53226

  • Local Institution - 0412

    Mineola, New York, 11501

  • Local Institution - 0109

    Murray, Utah, 84107

  • Local Institution - 0079

    Myrtle Beach, South Carolina, 29572

  • Local Institution - 0335

    Nashville, Tennessee, 37203

  • Local Institution - 0069

    New York, New York, 10016

  • Local Institution - 0076

    New York, New York, 10029

  • Local Institution - 0085

    New York, New York, 10032

  • Local Institution - 0071

    New York, New York, 10065

  • Local Institution - 0345

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0414

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 0057

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 0067

    Portland, Oregon, 97213

  • Local Institution - 0416

    Portland, Oregon, 97225

  • Local Institution - 0016

    San Francisco, California, 94115

  • Local Institution - 0411

    San Francisco, California, 94121

  • Local Institution - 0078

    Seattle, Washington, 98109

  • Local Institution - 0429

    Sewell, New Jersey, 08080

  • Local Institution - 0225

    Syracuse, New York, 13210

  • Local Institution - 0293

    Vancouver, Washington, 98684

  • Local Institution - 0413

    Washington D.C., District of Columbia, 20016

  • Local Institution - 0331

    Westwood, Kansas, 66205

  • Local Institution - 0060

    Wichita, Kansas, 67226

  • Local Institution - 0349

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Spain22 sites

  • Local Institution - 0320

    Badajoz, 06006

  • Local Institution - 0325

    Barakaldo, Bizkaia, 48903

  • Local Institution - 0310

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0315

    Barcelona, Catalunya [Cataluña], 08041

  • Local Institution - 0328

    Burgos, 09006

  • Local Institution - 0312

    Córdoba, Andalusia, 14004

  • Local Institution - 0318

    Granada, 18008

  • Local Institution - 0319

    Lugo, Lugo [Lugo], 27003

  • Local Institution - 0321

    Madrid, Madrid, Comunidad de, 28009

  • Local Institution - 0316

    Madrid, Madrid, Comunidad de, 28034

  • Local Institution - 0317

    Madrid, Madrid, Comunidad de, 28041

  • Local Institution - 0323

    Madrid, Madrid, Comunidad de, 28046

  • Local Institution - 0309

    Madrid, 28040

  • Local Institution - 0326

    Majadahonda, Madrid, Comunidad de, 28222

  • Local Institution - 0327

    Málaga, 29016

  • Local Institution - 0407

    Ourense, Ourense [Orense], 32005

  • Local Institution - 0406

    Pamplona, Navarre, 31009

  • Local Institution - 0311

    Sabadell, Barcelona [Barcelona], 08208

  • Local Institution - 0314

    Santander, Cantabria, 39008

  • Local Institution - 0322

    Seville, 41009

  • Local Institution - 0313

    Seville, 41013

  • Local Institution - 0324

    Valencia, 46026

Other trials in Spain

China20 sites

  • Local Institution - 0192

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0417

    Changzhou, Jiangsu, 213003

  • Local Institution - 0240

    Chengdu, Sichuan, 610041

  • Local Institution - 0278

    Chengdu, Sichuan, 610041

  • Local Institution - 0283

    Chengdu, Sichuan, 610072

  • Local Institution - 0249

    Fuzhou, Fujian, 350001

  • Local Institution - 0226

    Guangzhou, Guangdong, 510060

  • Local Institution - 0180

    Guangzhou, Guangdong, 510180

  • Local Institution - 0196

    Hangzhou, Zhejiang, 310014

  • Local Institution - 0232

    Hefei, Anhui, 230000

  • Local Institution - 0415

    Huizhou, Guangdong, 516001

  • Local Institution - 0191

    Jinan, Shandong, 250117

  • Local Institution - 0281

    Linhai, Zhejiang, 317000

  • Local Institution - 0219

    Nanchang, Jiangxi, 330209

  • Local Institution - 0233

    Nanjing, Jiangsu, 210000

  • Local Institution - 0229

    Nanjing, Jiangsu, 210009

  • Local Institution - 0214

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0218

    Ürümqi, Xinjiang, 830000

  • Local Institution - 0213

    Xiamen, Fujian, 361003

  • Local Institution - 0221

    Yantai, Shandong, 264099

Other trials in China

Australia16 sites

  • Local Institution - 0362

    Adelaide, South Australia, 5000

  • Local Institution - 0366

    Campbelltown, New South Wales, 2560

  • Local Institution - 0359

    Darlinghurst, New South Wales, 2010

  • Local Institution - 0358

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0347

    Greenslopes, Queensland, 4120

  • Local Institution - 0363

    Heidelberg, Victoria, 3084

  • Local Institution - 0354

    Hobart, Tasmania, 7000

  • Local Institution - 0352

    Kurralta Park, South Australia, 5037

  • Local Institution - 0356

    Macquarie University, New South Wales, 2109

  • Local Institution - 0353

    Malvern, Victoria, 3144

  • Local Institution - 0348

    Melbourne, Victoria, 3000

  • Local Institution - 0361

    Melbourne, Victoria, 3004

  • Local Institution - 0357

    Murdoch, Western Australia, 6150

  • Local Institution - 0360

    Port Macquarie, New South Wales, 2444

  • Local Institution - 0351

    Southport, Queensland, 4215

  • Local Institution - 0355

    Wahroonga, New South Wales, 2076

Other trials in Australia

Germany11 sites

  • Local Institution - 0382

    Bonn, 53127

  • Local Institution - 0375

    Essen, 45122

  • Local Institution - 0378

    Hamburg, 20246

  • Local Institution - 0379

    Heidelberg, D-69120

  • Local Institution - 0377

    Herne, 44625

  • Local Institution - 0380

    Jena, Thuringia, 07747

  • Local Institution - 0371

    Lübeck, Schleswig-Holstein, 23538

  • Local Institution - 0374

    München, Bavaria, 81675

  • Local Institution - 0421

    Nürtingen, Baden-Wurttemberg, 72622

  • Local Institution - 0376

    Tübingen, 72076

  • Local Institution - 0372

    Würzburg, 97080

Other trials in Germany

Canada9 sites

  • Local Institution - 0093

    Chicoutimi, Quebec, G7H 5H6

  • Local Institution - 0151

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution - 0304

    Kelowna, British Columbia, V1Y 5L3

  • Local Institution - 0149

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0305

    Montreal, Quebec, H4A 3J1

  • Local Institution - 0150

    Québec, Quebec, G1J 1Z4

  • Local Institution - 0164

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0193

    Toronto, Ontario, M4N 3M5

  • Local Institution - 0152

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

France9 sites

  • Local Institution - 0165

    Clermont-Ferrand, 63011

  • Local Institution - 0432

    Dijon, Côte-d'Or, 21079

  • Local Institution - 0231

    Le Mans, Sarthe, 72000

  • Local Institution - 0167

    Nice, Alpes-Maritimes, 06189

  • Local Institution - 0166

    Pierre-Bénite, Rhône, 69310

  • Local Institution - 0169

    Strasbourg, 67098

  • Local Institution - 0307

    Toulouse, Haute-Garonne, 31059

  • Local Institution - 0177

    Vandœuvre-lès-Nancy, Lorraine, 54519

  • Local Institution - 0179

    Villejuif, Val-de-Marne, 94800

Other trials in France

Italy9 sites

  • Local Institution - 0156

    Arezzo, 52100

  • Local Institution - 0409

    Foggia, 71100

  • Local Institution - 0157

    Milan, Lombardy, 20133

  • Local Institution - 0160

    Naples, 80131

  • Local Institution - 0234

    Orbassano, Piedmont, 10043

  • Local Institution - 0153

    Padova, Veneto, 35128

  • Local Institution - 0155

    Rome, Roma, 00144

  • Local Institution - 0159

    Terni, 05100

  • Local Institution - 0158

    Trento, 38122

Other trials in Italy

Argentina8 sites

  • Local Institution - 0128

    ABB, Buenos Aires F.D., C1199ABB

  • Local Institution - 0129

    Buenos Aires, C1419AHN

  • Local Institution - 0125

    CABA, Buenos Aires, CP1280AEB

  • Local Institution - 0124

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Local Institution - 0235

    Córdoba, Córdoba Province, X5004BAL

  • Local Institution - 0430

    Córdoba, 5016

  • Local Institution - 0130

    Río Cuarto, Córdoba Province, X5800AEV

  • Local Institution - 0136

    Viedma, R, R8500ACE

Other trials in Argentina

Poland8 sites

  • Local Institution - 0189

    Bydgoszcz, 85796

  • Local Institution - 0185

    Bytom, Silesian Voivodeship, 41-902

  • Local Institution - 0186

    Gdansk, Pomeranian Voivodeship, 80-219

  • Local Institution - 0336

    Katowice, 40-519

  • Local Institution - 0190

    Opole, Opole Voivodeship, 45-061

  • Local Institution - 0365

    Poznan, Greater Poland Voivodeship, 60-192

  • Local Institution - 0187

    Warsaw, Masovian Voivodeship, 02-507

  • Local Institution - 0346

    Wroclaw, Lower Silesian Voivodeship, 53-329

Other trials in Poland

Czechia6 sites

  • Local Institution - 0008

    Brno, Brno-město, 656 53

  • Local Institution - 0005

    Hradec Králové, Hradec Králové, 500 05

  • Local Institution - 0010

    Olomouc, Olomouc Region, 779 00

  • Local Institution - 0009

    Prague, Praha 2, 120 00

  • Local Institution - 0004

    Prague, Praha 5, 150 06

  • Local Institution - 0006

    Prague, 128 08

Other trials in Czechia

Mexico6 sites

  • Local Institution - 0122

    Chihuahua City, 31203

  • Local Institution - 0120

    Guadalajara, Jalisco, 44280

  • Local Institution - 0001

    Guadalajara, Jalisco, 44670

  • Local Institution - 0121

    Mexico City, DIF, 14080

  • Local Institution - 0002

    Monterrey, Nuevo León, 64460

  • Local Institution - 0119

    Puebla City, 72424

Other trials in Mexico

South Korea6 sites

  • Local Institution - 0389

    Goyang-si, Kyǒnggi-do, 10408

  • Local Institution - 0386

    Seongnam, Kyǒnggi-do, 13620

  • Local Institution - 0385

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Local Institution - 0387

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

  • Local Institution - 0388

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Local Institution - 0384

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

Other trials in South Korea

Brazil5 sites

  • Local Institution - 0025

    Belo Horizonte, Minas Gerais, 30110-022

  • Local Institution - 0035

    Natal, Rio Grande do Norte, 59075-740

  • Local Institution - 0026

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Local Institution - 0395

    São Paulo, São Paulo, 01308-060

  • Local Institution - 0031

    São Paulo, São Paulo, 01509-010

Other trials in Brazil

Israel5 sites

  • Local Institution - 0209

    Haifa, Northern District, 3109601

  • Local Institution - 0206

    Kfar Saba, Central District, 4428164

  • Local Institution - 0208

    Petah Tikva, Central District, 4941492

  • Local Institution - 0207

    Ramat Gan, Central District, 5265601

  • Local Institution - 0210

    Tsrifin, Central District, 70300

Other trials in Israel

Romania5 sites

  • Local Institution - 0144

    Cluj-Napoca, 400015

  • Local Institution - 0145

    Cluj-Napoca, 400015

  • Local Institution - 0139

    Craiova, Dolj, 200542

  • Local Institution - 0141

    Iași, 700483

  • Local Institution - 0142

    Ploieşti, 100337

Other trials in Romania

United Kingdom5 sites

  • Local Institution - 0393

    Glasgow, Glasgow City, G12 0YN

  • Local Institution - 0266

    London, London, City of, EC1A 7BE

  • Local Institution - 0391

    London, Sutton, SM2 5PT

  • Local Institution - 0248

    Manchester, M20 4BX

  • Local Institution - 0383

    Northwood, Hillingdon, HA6 2RN

Other trials in United Kingdom

Austria4 sites

  • Local Institution - 0369

    Krems, Lower Austria, 3500

  • Local Institution - 0373

    Linz, Upper Austria, 4020

  • Local Institution - 0367

    Salzburg, 5020

  • Local Institution - 0368

    Vienna, 1090

Other trials in Austria

Chile4 sites

  • Local Institution - 0135

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 0132

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0236

    Valdivia, Los Ríos Region, 5112129

  • Local Institution - 0127

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Denmark4 sites

  • Local Institution - 0100

    Aalborg, North Denmark, 9000

  • Local Institution - 0396

    Aarhus, Central Jutland, 8200

  • Local Institution - 0243

    Copenhagen, Capital Region, 2730

  • Local Institution - 0098

    Copenhagen, Capital Region, DK-2100

Other trials in Denmark

Finland4 sites

  • Local Institution - 0096

    Kuopio, Northern Savonia, 70210

  • Local Institution - 0101

    Oulu, 90220

  • Local Institution - 0285

    Tampere, Pirkanmaa, 33520

  • Local Institution - 0242

    Turku, Southwest Finland, 20521

Other trials in Finland

Sweden4 sites

  • Local Institution - 0095

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

  • Local Institution - 0099

    Lund, Skåne Län [se-12], 22185

  • Local Institution - 0408

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

  • Local Institution - 0097

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

Other trials in Sweden

Taiwan4 sites

  • Local Institution - 0398

    Taichung, 404332

  • Local Institution - 0399

    Taipei, 10002

  • Local Institution - 0397

    Taipei, 11217

  • Local Institution - 0420

    Taoyuan, 333

Other trials in Taiwan

Ireland3 sites

  • Local Institution - 0271

    Cork, T12 DC4A

  • Local Institution - 0272

    Dublin, D24 NR0A

  • Local Institution - 0273

    Dublin, D9

Other trials in Ireland

Puerto Rico1 site

  • Local Institution - 0117

    Yauco, 00698

Other trials in Puerto Rico

Slovakia1 site

  • Local Institution - 0381

    Prešov, Presov, 080 01

Other trials in Slovakia

About this study

Official title: A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

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.

Read the 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).

Being tested
BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
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
Medical subject headings
Prostatic Neoplasms, Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986365Drug

    Specified dose on specified days

  • EnzalutamideDrug

    Specified dose on specified days

  • AbirateroneDrug

    Specified dose on specified days

  • DocetaxelDrug

    Specified dose on specified days

  • Predinsone/PrednisoloneDrug

    Specified dose on specified days

Study groups in NCT06764485
Study groupRoleWhat they receive
Part 1: Dose 1ExperimentalNot described
Receives: Drug: BMS-986365
Part 1: Dose 2ExperimentalNot described
Receives: Drug: BMS-986365
Part 1: Comparator 1Active comparatorEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Receives: Drug: Enzalutamide; Drug: Abiraterone; Drug: Predinsone/Prednisolone
Part 1: Comparator 2Active comparatorNot described
Receives: Drug: Docetaxel; Drug: Predinsone/Prednisolone
Part 2: Dose SelectedExperimentalNot described
Receives: Drug: BMS-986365
Part 2: Comparator 1Active comparatorEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Receives: Drug: Enzalutamide; Drug: Abiraterone; Drug: Predinsone/Prednisolone
Part 2: Comparator 2Active comparatorNot described
Receives: Drug: Docetaxel; Drug: Predinsone/Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 4 years

Secondary outcomes (19)

  1. Overall Survival (OS)

    Measured: Up to 4 years

  2. Recommended dose of BMS-986365 for Part 2

    Measured: Up to approximately 1.5 years

  3. Progression-free survival (PFS)

    Measured: Up to 4 years

  4. Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria

    Measured: Up to 4 years

  5. Time to pain progression (TTPP)

    Measured: Up to 4 years

  6. Time to symptomatic progression (TTSP)

    Measured: Up to 4 years

  7. Time to initiation of the first subsequent systemic therapy (TFST)

    Measured: Up to 4 years

  8. Prostate-specific antigen (PSA) response rate

    Measured: Up to 4 years

  9. Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores

    Measured: Up to 4 years

  10. Change from baseline in Prostate Cancer Subscale (PCS) scores

    Measured: Up to 4 years

  11. Change from baseline in trial outcome index (TOI)

    Measured: Up to 4 years

  12. Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity

    Measured: Up to 4 years

  13. Incidence of adverse events (AEs)

    Measured: Up to 4 years

  14. Incidence of serious adverse events (SAEs)

    Measured: Up to 4 years

  15. Incidence of AEs leading to dose modifications

    Measured: Up to 4 years

  16. Incidence of AEs leading to interruptions

    Measured: Up to 4 years

  17. Incidence of AEs leading to discontinuation

    Measured: Up to 4 years

  18. Electrocardiogram (ECG) findings

    ECG Findings defined as :

    • Number of Postbaseline Abnormal Corrected QT (QTc) Values
    • Number of abnormal Beats Per Minute (BPM)

    Measured: Up to 4 years

  19. Incidence of laboratory abnormalities

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start13 Mar 2025
  3. Primary completion12 Sep 2027 (estimated)
  4. Study completion19 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764485
Sponsor's protocol ID
CA071-1000
Other IDs
2024-517422-25, U1111-1311-0532
Acronym
rechARge
Status last verified
Sep 2026
First submitted
17 Dec 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 39293515

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-986365, Enzalutamide and Abiraterone in people with Metastatic Castration-resistant Prostate Cancer, run by Celgene at 227 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Spain, China, Australia, Germany and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06764485, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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