RecruitingPhase 3NCT06764485

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, 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

Sponsor

Celgene

Enrollment

960 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a new drug called BMS-986365 against the doctor's choice of standard therapy in men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to hormone therapy). **You may be eligible if...** - You have prostate cancer confirmed by biopsy (specifically adenocarcinoma) - Your cancer has spread to bones or soft tissue and is visible on scans - You are asymptomatic or only mildly symptomatic from your cancer (pain score below 4) - You have already received treatment with a hormone pathway drug (such as abiraterone, enzalutamide, apalutamide, or darolutamide) **You may NOT be eligible if...** - Your cancer is the small cell or neuroendocrine subtype - You have significant heart problems or impaired cardiac function - You have not yet tried any androgen receptor pathway inhibitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986365

Specified dose on specified days

DRUGEnzalutamide

Specified dose on specified days

DRUGAbiraterone

Specified dose on specified days

DRUGDocetaxel

Specified dose on specified days

DRUGPredinsone/Prednisolone

Specified dose on specified days

Locations(279)

Central Alabama Research

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Los Angeles Cancer Network (LACN)

Anaheim, California, United States

Moores Cancer Center

La Jolla, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Local Institution - 0364

Los Angeles, California, United States

Pacific Hematology Oncology Associates

San Francisco, California, United States

San Francisco VA Health Care System

San Francisco, California, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Sibley Memorial Hospital

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

Lakeland Regional Cancer Center

Lakeland, Florida, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States

Wichita Urology Group

Wichita, Kansas, United States

Chesapeake Urology

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

James M Stockman Cancer Institute

Frederick, Maryland, United States

Local Institution - 0104

Minneapolis, Minnesota, United States

Local Institution - 0049

Las Vegas, Nevada, United States

Thomas Jefferson University, Kennedy Health Alliance

Sewell, New Jersey, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Local Institution - 0085

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Associated Medical Professionals - Urology

Syracuse, New York, United States

Local Institution - 0056

Columbus, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Local Institution - 0433

Allentown, Pennsylvania, United States

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Hollings Cancer Center

Charleston, South Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Tennessee Oncology

Nashville, Tennessee, United States

Urology Austin, PLLC

Austin, Texas, United States

Texas Oncology - Central/South Texas

Austin, Texas, United States

Local Institution - 0220

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Local Institution - 0023

Richmond, Virginia, United States

Local Institution - 0078

Seattle, Washington, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Hospital Británico de Buenos Aires

CABA, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Hospital Italiano de Córdoba

Córdoba, Córdoba Province, Argentina

Local Institution - 0130

Río Cuarto, Córdoba Province, Argentina

Clinica Viedma S. A

Viedma, R, Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Argentina

Hospital Privado Universitario de Córdoba

Córdoba, Argentina

GenesisCare - Campbelltown

Campbelltown, New South Wales, Australia

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Macquarie University

Macquarie University, New South Wales, Australia

Port Macquarie - Mid North Coast Cancer Institute

Port Macquarie, New South Wales, Australia

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Greenslopes Private Hospital - Gallipoli Medical Research Foundation

Greenslopes, Queensland, Australia

Tasman Oncology Research

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

ICON Cancer Centre - Kurralta Park

Kurralta Park, South Australia, Australia

Icon Cancer Centre Hobart

Hobart, Tasmania, Australia

Austin Health

Heidelberg, Victoria, Australia

Cabrini Hospital - Malvern

Malvern, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Universitätsklinikum Krems

Krems, Lower Austria, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Uniklinikum Salzburg

Salzburg, Austria

Medizinische Universität Wien

Vienna, Austria

Local Institution - 0039

Vitória, Espírito Santo, Brazil

Cetus Oncologia - Unidade Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sírio Libanês

São Paulo, São Paulo, Brazil

A. C. Camargo Cancer Center

São Paulo, São Paulo, Brazil

BC Cancer Kelowna

Kelowna, British Columbia, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski

Rimouski, Quebec, Canada

Oncocentro Valdivia

Valdivia, Los Ríos Region, Chile

Fundacion Arturo Lopez Perez (FALP)

Santiago, Santiago Metropolitan, Chile

Bradfordhill

Santiago, Santiago Metropolitan, Chile

Oncocentro Apys

Viña del Mar, Valparaiso, Chile

Second Affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Local Institution - 0168

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Local Institution - 0176

Beijing, Beijing Municipality, China

Local Institution - 0237

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Local Institution - 0415

Huizhou, Guangdong, China

Local Institution - 0222

Harbin, Heilongjiang, China

Local Institution - 0211

Zhengzhou, Henan, China

Local Institution - 0279

Zhengzhou, Henan, China

Local Institution - 0284

Wuhan, Hubei, China

Local Institution - 0216

Changsha, Hunan, China

Local Institution - 0217

Changsha, Hunan, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Local Institution - 0228

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The First affiliated hospital of Nanchang University (Xianghu campus)

Nanchang, Jiangxi, China

Local Institution - 0198

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Local Institution - 0300