Back to Trials
NCT07164443PHASE3Recruiting

A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Janssen Research & Development, LLC

Start Date

9/2/2025

Completion Date

8/18/2028

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 combination with best supportive care (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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Histologically confirmed adenocarcinoma of the prostate * Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\^Tc bone scan * PSA greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL) at screening * In the opinion of the investigator, the next best treatment option is a clinical trial * Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: 1. Cabazitaxel is not available 2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Participants who cannot continue taxane therapy because of a documented Grade\>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment Radioligand therapy: Should have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: 1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. 2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available * Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \[agonist or antagonist\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Participants are eligible if they have the following values: A) eGFR \>= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (\<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin \<= 3 times ULN D) Absolute neutrophil count (ANC) \>= 1.0x10\^9/per liter (L) E) Hemoglobin \>= 8.0 grams per deciliter (g/dL) F) Platelet count \>= 75x10\^9/L Exclusion Criteria * Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade \<= 2) deep vein thrombosis is not exclusionary * Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus) * Participants with Grade 1 or higher fever (\>=38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (\<38ºC) at the time of study treatment dosing unless approved by medical monitor * Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation * Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Any of the following within 6 months prior to first dose of study treatment: A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident \- Prior treatment with any CD3-directed therapy

Interventions

BIOLOGICAL

Pasritamig

OTHER

Placebo

DRUG

Best Supportive Care (BSC)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Metastatic Castration-resistant Prostate Neoplasms

Locations

University of California at San Diego

La Jolla, California 92093

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

Rocky Mountain Cancer Centers

Aurora, Colorado 80012

United States

University of Colorado Cancer Center

Aurora, Colorado 80045

United States

Colorado Clinical Research

Lakewood, Colorado 80228

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Washington D.C., District of Columbia 20016

United States

Bay Pines VA Healthcare System

Bay Pines, Florida 33744

United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida 33901

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States

Mission Cancer Blood

Waukee, Iowa 50263

United States

East Jefferson General Hospital

Metairie, Louisiana 70006

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02115

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

Henry Ford Cancer Detroit

Detroit, Michigan 48202

United States

University Of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska 68130

United States

NYU Langone Hospitals

Brooklyn, New York 11220

United States

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

Columbia University Medical Center

New York, New York 10032

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

University Hospital of Cleveland

Cleveland, Ohio 44106

United States

Compass Oncology

Portland, Oregon 97227

United States

VA Portland Health Care System

Portland, Oregon 97239

United States

Oregon Urology Institute

Springfield, Oregon 97477

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

Keystone Urology Specialists

Lancaster, Pennsylvania 17601

United States

Penn Medicine Abramson Cancer Center

Philadelphia, Pennsylvania 19104

United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania 15232

United States

Ralph H Johnson Veterans Hospital

Charleston, South Carolina 29401

United States

Gibbs Cancer Center and Research Institute Pelham

Greer, South Carolina 29650

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

Gibbs Cancer Center

Spartanburg, South Carolina 29303

United States

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee 37404

United States

Tennessee Oncology Nashville

Nashville, Tennessee 37203

United States

Urology Clinics of North Texas

Dallas, Texas 75231

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Michael E DeBakey VA Medical Center

Houston, Texas 77030

United States

Texas Oncology West Texas

Wichita Falls, Texas 76310

United States

Utah Cancer Specialists

Salt Lake City, Utah 84106

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Blue Ridge Cancer Care

Roanoke, Virginia 24014

United States

VA Puget Sound Healthcare System

Seattle, Washington 98108

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

University of Washington

Seattle, Washington 98195

United States

Warringal Private Hospital

Heidelberg, 3084

Australia

ICON Cancer Care

Kurralta Park, 5037

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

Fiona Stanley Hospital

Murdoch, 6150

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

AZ Sint-Jan

Bruges, 8000

Belgium

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Az Groeninge

Kortrijk, 8500

Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, 7100

Belgium

CHC MontLegia

Liège, 4000

Belgium

Clinique Saint Pierre

Ottignies, 1340

Belgium

ZAS Augustinus

Wilrijk, 2610

Belgium

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, 88034 000

Brazil

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

Joinville, 89201 260

Brazil

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000

Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90560032

Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900

Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

BC Cancer Vancouver

Vancouver, British Columbia V5Z 4E6

Canada

Lakeridge Health

Oshawa, Ontario L1G2B9

Canada

Sunnybrook Health Sciences Center

Toronto, Ontario M4N 3M5

Canada

Princess Margaret Hospital

Toronto, Ontario M5G 2C1

Canada

CHU de Quebec Universite Laval

Québec, Quebec G1J 1Z4

Canada

Peking University First Hospital

Beijing, 100034

China

The First Bethune Hospital of Jilin University

Changchun, 130021

China

The Third People's Hospital of Chengdu

Chengdu, 500643

China

West China Hospital of Sichuan University

Chengdu, 610041

China

Chongqing University Cancer Hospital

Chongqing, 400030

China

Sun Yat Sen University Cancer Center

Guangzhou, 510060

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

The First Affiliated Hospital of Guangxi Medical University

Nanning, 530021

China

Nantong Tumor Hospital

Nantong, 226300

China

The First Affiliated Hospital of Ningbo University

Ningbo, 315010

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

The Second Hospital Of Tianjin Medical University

Tianjin, 300211

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Zhongnan Hospital Wu Han University

Wuhan, 430071

China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061

China

Institut Bergonie

Bordeaux, 33000

France

CHRU Brest - Hopital Morvan

Brest, 29200

France

Centre Georges Francois Leclerc

Dijon, 21000

France

Centre Oscar Lambret

Lille, 59000

France

Centre Leon Berard

Lyon, 69008

France

Hopital Saint Joseph

Paris, 75014

France

CHU Lyon Sud

Pierre-Bénite, 69495

France

I.C.O. Rene Gauducheau

Saint-Herblain, 44805

France

Hopitaux universitaires de Strasbourg

Strasbourg, 672098

France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519

France

Gustave Roussy

Villejuif, 94800

France

Staedtisches Klinikum Braunschweig

Braunschweig, 38126 DE

Germany

Urologicum Duisburg

Duisburg, 47169

Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Krankenhaus NorthWest

Frankfurt am Main, 60488

Germany

Martini-Klinik am UKE GmbH

Hamburg, 20246

Germany

Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen

Heidelberg, 69120

Germany

Klinikum rechts der Isar der TU Muenchen

München, 81675

Germany

Universitaetsklinikum Muenster

Münster, 48149

Germany

Klinikum Nuernberg Nord

Nuremberg, 90419

Germany

Studienpraxis Urologie Nurtingen

Nürtingen, 72622

Germany

Ospedali Riuniti Foggia

Foggia, 71122

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

Azienda Ospedaliera Universitaria Federico II

Naples, 80131

Italy

IOV IRCCS Padova

Padova, 35128

Italy

Azienda Di Rilievo Nazionale E Di Alta Specializzazione

Palermo, 90127

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

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

Torino, 10126

Italy

Institute of Science Tokyo Hospital

Bunkyō City, 113 8519

Japan

Kyushu University Hospital

Fukuoka, 812 8582

Japan

Saitama Medical University International Medical Center

Hidaka, 350 1298

Japan

Kanazawa University Hospital

Kanazawa, 920 8641

Japan

National Cancer Center Hospital East

Kashiwa, 277 8577

Japan

Kobe University Hospital

Kobe, 650 0017

Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, 791-0280

Japan

National Hospital Organization Tokyo Medical Center

Meguro Ku, 152 8902

Japan

Toho University Sakura Medical Center

Sakura, 285-8741

Japan

Yokohama City University Medical Center

Yokohama, 232 0024

Japan

Yokohama City University Hospital

Yokohama, 236 0004

Japan

Yokosuka Kyosai Hospital

Yokosuka, 238 8558

Japan

Reinier de Graaf Gasthuis

Delft, 2625 AD

Netherlands

Martini Ziekenhuis

Groningen, 9728NT

Netherlands

Tergooi

Hilversum, 1212 VG

Netherlands

Spaarne Gasthuis

Hoofddorp, 2134 TM

Netherlands

Maastricht UMC

Maastricht, 6229 HX

Netherlands

Canisius-Wilhelmina ZH

Nijmegen, 6532 SZ

Netherlands

Erasmus MC

Rotterdam, 3015 GD

Netherlands

Isala Kliniek

Zwolle, 8025 AB

Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15 276

Poland

IN VIVO Sp. z o.o

Bydgoszcz, 85 048

Poland

Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

Koszalin, 75-581

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02 781

Poland

Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

Warsaw, 04 073

Poland

Pan American Center for Oncology Trials LLC

Rio Piedras, 00935

Puerto Rico

Puerto Rico Medical Research Center

San Juan, 00917

Puerto Rico

Chungnam National University Hospital

Daejeon, 35015

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Chonnam National University Hwasun Hospital

Hwasungun, 58128

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 Vall D Hebron

Barcelona, 08035

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Virgen de La Victoria

Málaga, 29010

Spain

Chang Gung Memorial Hospital

Kaohsiung City, 833

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, 435

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH

United Kingdom

University College London Hospitals

London, WC1E 6BT

United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX

United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT

United Kingdom