RecruitingPhase 3NCT07164443

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

1,203 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostatic Neoplasms

Summary

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called pasritamig can extend the lives of men with metastatic castration-resistant prostate cancer (mCRPC) — prostate cancer that has spread and continues to grow despite hormone-blocking treatments. It compares pasritamig against placebo in patients who have already tried multiple lines of therapy. **You may be eligible if...** - You have confirmed prostate cancer that has spread to bone or lymph nodes and is no longer responding to hormone therapy - Your PSA level is at least 2 ng/mL - You have already tried multiple approved therapies for prostate cancer (including androgen receptor blockers and other standard treatments) - In your doctor's opinion, the best next option for you is a clinical trial **You may NOT be eligible if...** - Your cancer has spread to visceral organs (liver, lungs) - You have not had the required prior treatments - You have serious other health conditions that would prevent safe participation 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

BIOLOGICALPasritamig

Pasritamig will be administrated through IV infusion.

OTHERPlacebo

Placebo will be administrated through IV infusion.

DRUGBest Supportive Care (BSC)

BSC will be administered at the discretion of the treating physician.

BIOLOGICALJNJ-87189401

JNJ-87189401 will be administered.

Locations(173)

University of California at San Diego

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

San Francisco VA Medical Center

San Francisco, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

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

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Mission Cancer Blood

Waukee, Iowa, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Henry Ford Cancer Detroit

Detroit, Michigan, United States

University Of Minnesota Medical Center

Minneapolis, Minnesota, United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States

NYU Langone Hospitals

Brooklyn, New York, United States

NYU Langone Hospital Long Island

Mineola, New York, United States

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Compass Oncology

Portland, Oregon, United States

VA Portland Health Care System

Portland, Oregon, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Penn Medicine Abramson Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Ralph H Johnson Veterans Hospital

Charleston, South Carolina, United States

Gibbs Cancer Center and Research Institute Pelham

Greer, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Gibbs Cancer Center

Spartanburg, South Carolina, United States

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, United States

Tennessee Oncology Nashville

Nashville, Tennessee, United States

Urology Clinics of North Texas

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Texas Oncology West Texas

Wichita Falls, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

VA Puget Sound Healthcare System

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Warringal Private Hospital

Heidelberg, Australia

ICON Cancer Care

Kurralta Park, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

AZ Sint-Jan

Bruges, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

AZ Maria Middelares

Ghent, Belgium

Ghent University Hospital

Ghent, Belgium

Az Groeninge

Kortrijk, Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, Belgium

CHC MontLegia

Liège, Belgium

Clinique Saint Pierre

Ottignies, Belgium

ZAS Augustinus

Wilrijk, Belgium

Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

Florianópolis, Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Lakeridge Health

Oshawa, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

CHU de Quebec Universite Laval

Québec, Quebec, Canada

Peking University First Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

The Third People's Hospital of Chengdu

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Sun Yat Sen University Cancer Center

Guangzhou, China

Nanjing Drum Tower Hospital

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Nantong Tumor Hospital

Nantong, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Fudan University Shanghai Cancer Center

Shanghai, China

The Second Hospital Of Tianjin Medical University

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Zhongnan Hospital Wu Han University

Wuhan, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Institut Bergonie

Bordeaux, France

CHRU Brest - Hopital Morvan

Brest, France

Centre Georges Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Hopital Saint Joseph

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

I.C.O. Rene Gauducheau

Saint-Herblain, France

Hopitaux universitaires de Strasbourg

Strasbourg, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

Staedtisches Klinikum Braunschweig

Braunschweig, Germany

Urologicum Duisburg

Duisburg, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Universitaetsklinikum Essen

Essen, Germany

Krankenhaus NorthWest

Frankfurt am Main, Germany

Martini-Klinik am UKE GmbH

Hamburg, Germany

Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen

Heidelberg, Germany

Klinikum rechts der Isar der TU Muenchen

München, Germany

Universitaetsklinikum Muenster

Münster, Germany

Klinikum Nuernberg Nord

Nuremberg, Germany

Studienpraxis Urologie Nurtingen

Nürtingen, Germany

Ospedali Riuniti Foggia

Foggia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

IOV IRCCS Padova

Padova, Italy

Azienda Di Rilievo Nazionale E Di Alta Specializzazione

Palermo, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Torino, Italy

Institute of Science Tokyo Hospital

Bunkyō City, Japan

Kyushu University Hospital

Fukuoka, Japan

Saitama Medical University International Medical Center

Hidaka, Japan

Kanazawa University Hospital

Kanazawa, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Kobe University Hospital

Kobe, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

National Hospital Organization Tokyo Medical Center

Meguro Ku, Japan

Toho University Sakura Medical Center

Sakura, Japan

Yokohama City University Medical Center

Yokohama, Japan

Yokohama City University Hospital

Yokohama, Japan

Yokosuka Kyosai Hospital

Yokosuka, Japan

Reinier de Graaf Gasthuis

Delft, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Tergooi

Hilversum, Netherlands

Spaarne Gasthuis

Hoofddorp, Netherlands

Maastricht UMC

Maastricht, Netherlands

Canisius-Wilhelmina ZH

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Isala Kliniek

Zwolle, Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

IN VIVO Sp. z o.o

Bydgoszcz, Poland

Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

Koszalin, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

Warsaw, Poland

Pan American Center for Oncology Trials LLC

Rio Piedras, Puerto Rico

Puerto Rico Medical Research Center

San Juan, Puerto Rico

Chungnam National University Hospital

Daejeon, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Hwasungun, 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 Vall D Hebron

Barcelona, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

University College London Hospitals

London, United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07164443