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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07164443

Registry updated: 2026-09-25
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Description

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).

Interventions

  • Pasritamig (Biological)
    Pasritamig will be administrated through IV infusion.
  • Placebo (Other)
    Placebo will be administrated through IV infusion.
  • Best Supportive Care (BSC) (Drug)
    BSC will be administered at the discretion of the treating physician.
  • JNJ-87189401 (Biological)
    JNJ-87189401 will be administered.

Eligibility criteria

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. Visceral disease is not allowed * 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 are required to 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: Required to 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 Radioligand therapy: Required to 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): Required to 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 ≥ 40 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the Upper Limit of Normal (ULN) C) Total bilirubin \<1.5 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

Conditions

Metastatic Castration-resistant Prostatic Neoplasms

Locations

  • 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
  • Gifu University Hospital — Gifu, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record