RecruitingPhase 3NCT07225946

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

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

800 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

Prostatic Neoplasms, Castration-Resistant

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) 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new combination treatment (pasritamig plus docetaxel, a chemotherapy) against chemotherapy alone (docetaxel) in men with advanced prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy. **You may be eligible if...** - You have been confirmed to have prostate cancer that has spread (metastatic) - Your cancer no longer responds to hormone therapy (castration-resistant), with testosterone levels very low - You have already tried at least one but no more than two newer hormone-blocking medications (ARPIs) - You have good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to the brain or the lining of the brain - You have a BRCA1/2 gene mutation and have not yet tried a PARP inhibitor drug - You have another active cancer - You have received chemotherapy for prostate cancer before - You have received prior KLK-2 targeted therapy 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

DRUGPasritamig

Pasritamig will be administered.

DRUGDocetaxel

Docetaxel will be administered.

DRUGPrednisone

Prednisone will be administered.

Locations(97)

Arizona Clinical Trials

Chandler, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

University Of California San Diego

La Jolla, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Kaiser Permanente Southern California

Riverside, California, United States

Providence Saint John s Health Center

Santa Monica, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Duly Health and Care

Lisle, Illinois, United States

Cancer Center of Kansas Heritage Plaza Medical Building

Wichita, Kansas, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Profound Research LLC at Cancer and Leukemia Center

Sterling Heights, Michigan, United States

HealthPartners Frauenshuh Cancer Center CRC West

Saint Louis Park, Minnesota, United States

HealthPartners Cancer Center at Regions Hospital CRC East

Saint Paul, Minnesota, United States

NHO Revive Research Institute, LLC

Lincoln, Nebraska, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Oregon Urology Institute

Springfield, Oregon, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Avera Medical Group

Sioux Falls, South Dakota, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Houston Metro Urology

Houston, Texas, United States

Texas Oncology 1

Sugar Land, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Fred Hutch Cancer Center Sloan Clinic 2

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Icon Cancer Centre Kurralta Park

Kurralta Park, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Sydney Adventist Hospital

Wahroonga, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

ZAS Augustinus

Antwerp, Belgium

AZ Maria Middelares

Ghent, Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, Belgium

CHC MontLegia

Liège, Belgium

NAIC Nair Antunes Instituto do Cancer

Bauru, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil

ESHO Empresa De Servicos Hospitalares S A

São Paulo, Brazil

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre de Recherche du CHUM

Montreal, Quebec, Canada

CHU de Quebec Universite Laval

Québec, Quebec, Canada

Beijing Luhe Hospital, Capital Medical University

Beijing, China

The Third People's Hospital of Chengdu

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

Sun Yat Sen University Cancer Center

Guangzhou, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

Nanjing Drum Tower Hospital

Nanjing, China

The Second Hospital Of Tianjin Medical University

Tianjin, China

The Central Hospital of Wuhan

Wuhan, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Centre Oscar Lambret

Lille, France

Groupe Hospitalo-Universitaire Carémeau

Nîmes, France

Hopital Europeen Georges-Pompidou

Paris, France

Gustave Roussy

Villejuif, France

Kanazawa University Hospital

Kanazawa, Japan

Kitasato University Hospital

Sagamihara, Japan

Yokohama City University Medical Center

Yokohama, Japan

Hospital Wanita dan Kanak-Kanak Sabah

Kota Kinabalu, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Pan American Center for Oncology Trials LLC

San Juan, Puerto Rico

National Cancer Center

Goyang-si, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp. Univ. 12 de Octubre

Madrid, Spain

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

Murcia, Spain

Hosp. Virgen Macarena

Seville, Spain

Hosp. Gral. Univ. Valencia

Valencia, Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, Spain

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Istanbul University Cerrahpasa tip Fakultesi

Istanbul, Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, Turkey (Türkiye)

Medicana International Izmir

Izmir, Turkey (Türkiye)

Velindre Cancer Centre

Cardiff, United Kingdom

Beatson West Of Scotland Cancer Centre

Glasgow, United Kingdom

St Bartholomews Hospital

London, United Kingdom

The Royal Marsden NHS Trust

London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

Newcastle upon Tyne, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

Preston, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07225946

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