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NCT07225946PHASE3Recruiting

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

Janssen Research & Development, LLC

Start Date

12/19/2025

Completion Date

7/20/2029

Summary

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Have histologically confirmed adenocarcinoma of the prostate * Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m\^Tc bone scan as determined by the investigator * Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening * Have progressed by PSA or CT/MRI or 99m\^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 Exclusion criteria: * Known history of either brain or leptomeningeal prostate cancer metastases * Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated * Prior or concurrent second malignancy (other than the disease under study) * Received cytotoxic chemotherapy for prostate cancer in any setting * Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Interventions

DRUG

Pasritamig

DRUG

Docetaxel

DRUG

Prednisone/Prednisolone

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Conditions

Prostatic Neoplasms, Castration-Resistant

Locations

Arizona Clinical Trials

Chandler, Arizona 85225

United States

Arkansas Urology

Little Rock, Arkansas 72211

United States

MemorialCare Orange Coast Medical Center

Fountain Valley, California 92708

United States

University Of California San Diego

La Jolla, California 92037

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Kaiser Permanente Southern California

Riverside, California 92505

United States

Sharp Center for Research

San Diego, California 92123

United States

Providence Saint John s Health Center

Santa Monica, California 90404

United States

Rocky Mountain Cancer Centers

Aurora, Colorado 80012

United States

Vail Health Shaw Cancer Center

Edwards, Colorado 81632

United States

Grand Valley Oncology

Grand Junction, Colorado 81505

United States

Colorado Clinical Research

Lakewood, Colorado 80228

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Winship Cancer Institute Emory University

Atlanta, Georgia 30322

United States

Duly Health and Care

Lisle, Illinois 60532

United States

Cancer Center of Kansas Heritage Plaza Medical Building

Wichita, Kansas 67214

United States

St Elizabeth Healthcare

Edgewood, Kentucky 41017

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

East Jefferson General Hospital

Metairie, Louisiana 70006

United States

University of Maryland

Baltimore, Maryland 21201

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Johns Hopkins Medical Institutions

Baltimore, Maryland 21287

United States

Chesapeake Urology Research Associates

Towson, Maryland 21204

United States

Profound Research LLC at Cancer and Leukemia Center

Sterling Heights, Michigan 48314

United States

HealthPartners Frauenshuh Cancer Center CRC West

Saint Louis Park, Minnesota 55426

United States

HealthPartners Cancer Center at Regions Hospital CRC East

Saint Paul, Minnesota 55101

United States

Washington University

St Louis, Missouri 63110

United States

NHO Revive Research Institute, LLC

Lincoln, Nebraska 68506

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York 11501

United States

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York 10016

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Oregon Urology Institute

Springfield, Oregon 97477

United States

Lehigh Valley Hospital

Allentown, Pennsylvania 18103

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

Avera Medical Group

Sioux Falls, South Dakota 57105

United States

Tennessee Cancer Specialists

Knoxville, Tennessee 37909

United States

Texas Oncology

Austin, Texas 78731

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Houston Metro Urology

Houston, Texas 77027

United States

Texas Oncology 1

Sugar Land, Texas 77479

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Fred Hutch Cancer Center Sloan Clinic 2

Seattle, Washington 98109

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

Warringal Private Hospital

Heidelberg, 3084

Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, 5037

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

Sydney Adventist Hospital

Wahroonga, 2076

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

AZORG campus Aalst Moorselbaan

Aalst, 9300

Belgium

ZAS Augustinus

Antwerp, 2610

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, 7100

Belgium

CHC MontLegia

Liège, 4000

Belgium

NAIC Nair Antunes Instituto do Cancer

Bauru, 17033-495

Brazil

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000

Brazil

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, 96835-100

Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, 09060 870

Brazil

ESHO Empresa De Servicos Hospitalares S A

São Paulo, 01232 010

Brazil

British Columbia Cancer Agency

Vancouver, British Columbia V5Z4E6

Canada

British Columbia Cancer Agency Vancouver Island Centre

Victoria, British Columbia V8R 6V5

Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario K1H 8L6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2C4

Canada

Centre de Recherche du CHUM

Montreal, Quebec H2X 0A9

Canada

CHU de Quebec Universite Laval

Québec, Quebec G1R 2J6

Canada

Beijing Cancer Hospital

Beijing, 100142

China

Beijing Luhe Hospital, Capital Medical University

Beijing, 101100

China

The Third People's Hospital of Chengdu

Chengdu, 610014

China

West China Hospital Sichuan University

Chengdu, 610041

China

Chongqing University Cancer Hospital

Chongqing, 400030

China

Sun Yat Sen University Cancer Center

Guangzhou, 510060

China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120

China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310009

China

Nanjing Drum Tower Hospital

Nanjing, 210009

China

Huashan Hospital Fudan University

Shanghai, 200031

China

Shanghai General Hospital

Shanghai, 200080

China

Xinhua hospital,Shanghai Jiaotong University

Shanghai, 200082

China

The Second Hospital Of Tianjin Medical University

Tianjin, 300211

China

The Central Hospital of Wuhan

Wuhan, 430014

China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061

China

Institut Bergonie

Bordeaux, 33076

France

Centre Jean Perrin

Clermont-Ferrand, 63011

France

Centre Oscar Lambret

Lille, 59000

France

Centre Leon Berard

Lyon, 69008

France

Groupe Hospitalo-Universitaire Carémeau

Nîmes, 30900

France

Hopital Europeen Georges-Pompidou

Paris, 75908

France

Centre Eugene Marquis

Rennes, 35062

France

Gustave Roussy

Villejuif, 94800

France

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Urologicum Duisburg

Duisburg, 47169

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

Hamburg, 20246

Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, 81675

Germany

Studienpraxis Urologie Drs. Feyerabend

Nürtingen, 72622

Germany

Azienda Ospedaliero Universitaria Careggi

Florence, 50134

Italy

ASL Napoli 2 Nord-SM delle Grazie Hospital

Localita La Schiana Pozzuoli, 80078

Italy

IRCCS Ospedale San Raffaele

Milan, 20132

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

Istituto Nazionale Tumori Regina Elena

Roma, 00144

Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

Juntendo University Hospital

Bunkyō City, 113 8431

Japan

Kansai Medical University Hospital

Hirakata, 573-1191

Japan

Kanazawa University Hospital

Kanazawa, 920 8641

Japan

Kobe University Hospital

Kobe, 650 0017

Japan

Kitasato University Hospital

Sagamihara, 252-0375

Japan

Shizuoka Cancer Center

Sunto Gun, 411 8777

Japan

Yokohama City University Medical Center

Yokohama, 232 0024

Japan

Hospital Wanita dan Kanak-Kanak Sabah

Kota Kinabalu, 88996

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

Pantai Hospital Kuala Lumpur

Kuala Lumpur, 59100

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Hospital Umum Sarawak

Kuching, 93586

Malaysia

Pan American Center for Oncology Trials LLC

San Juan, 935

Puerto Rico

National Cancer Center

Goyang-si, 10408

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591

South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, 30008

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Hosp. Gral. Univ. Valencia

Valencia, 46014

Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009

Spain

China Medical University Hospital

Taichung, 404

Taiwan

Taichung Veterans General Hospital

Taichung, 407219

Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, 435

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Adana City Hospital

Adana, 01170

Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, 06010

Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, 06100

Turkey (Türkiye)

Istanbul University Cerrahpasa tip Fakultesi

Istanbul, 34096

Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, 34147

Turkey (Türkiye)

Medicana International Izmir

Izmir, 35170

Turkey (Türkiye)

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

Beatson West Of Scotland Cancer Centre

Glasgow, G12 0YN

United Kingdom

St Bartholomews Hospital

London, EC1A 7BE

United Kingdom

The Royal Marsden NHS Trust

London, SW3 6JJ

United Kingdom

The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

Newcastle upon Tyne, NE7 7DN

United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

Preston, PR2 9HT

United Kingdom

Royal Marsden Hospital

Sutton, SM2 5PT

United Kingdom