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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07225946

Registry updated: 2026-09-25
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Description

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).

Interventions

  • Pasritamig (Drug)
    Pasritamig will be administered.
  • Docetaxel (Drug)
    Docetaxel will be administered.
  • Prednisone/Prednisolone (Drug)
    Prednisone/Prednisolone will be administered.

Eligibility criteria

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

Conditions

Prostatic Neoplasms, Castration-Resistant

Locations

  • Arizona Clinical Trials — Chandler, Arizona, United States
  • Arkansas Urology — Little Rock, Arkansas, United States
  • MemorialCare Orange Coast Medical Center — Fountain Valley, California, United States
  • University Of California San Diego — La Jolla, California, United States
  • Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
  • USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • Valkyrie Clinical Trials — Los Angeles, California, United States
  • Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
  • Kaiser Permanente Southern California — Riverside, California, United States
  • Sharp Center for Research — San Diego, California, United States
  • Providence Saint John s Health Center — Santa Monica, California, United States
  • Rocky Mountain Cancer Centers — Aurora, Colorado, United States
  • AdventHealth Porter Oncology Research — Denver, Colorado, United States
  • Vail Health Shaw Cancer Center — Edwards, Colorado, United States
  • Grand Valley Oncology — Grand Junction, Colorado, United States
  • Colorado Clinical Research — Lakewood, Colorado, United States
  • AdventHealth Orlando — Orlando, Florida, United States
  • Florida Cancer Specialists — Sarasota, Florida, United States
  • Winship Cancer Institute Emory University — Atlanta, Georgia, United States
  • Duly Health and Care — Lisle, Illinois, United States
  • Cancer Center of Kansas Heritage Plaza Medical Building — Wichita, Kansas, United States
  • St Elizabeth Healthcare — Edgewood, Kentucky, United States
  • Norton Cancer Institute — Louisville, Kentucky, United States
  • East Jefferson General Hospital — Metairie, Louisiana, United States
  • University of Maryland — Baltimore, Maryland, United States
  • Johns Hopkins Hospital — Baltimore, Maryland, United States
  • Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
  • Chesapeake Urology Research Associates — Towson, Maryland, United States
  • Massachusetts General — Boston, Massachusetts, 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
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • Washington University — St Louis, Missouri, United States
  • NHO Revive Research Institute, LLC — Lincoln, Nebraska, United States
  • Astera Cancer Care — East Brunswick, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • Laura & Isaac Perlmutter Cancer Center at 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
  • Montefiore Medical Center — The Bronx, New York, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • University of Cincinnati — Cincinnati, Ohio, 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
  • Prairie Lakes Health Care System — Watertown, South Dakota, United States
  • Tennessee Cancer Specialists — Knoxville, Tennessee, United States
  • Texas Oncology — Austin, Texas, United States
  • UT Southwestern Medical Center — Dallas, Texas, United States
  • Houston Metro Urology — Houston, Texas, United States
  • Texas Oncology 1 — Sugar Land, Texas, United States
  • Renovatio Clinical — The Woodlands, 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
  • Warringal Private Hospital — Heidelberg, Australia
  • Icon Cancer Centre Kurralta Park — Kurralta Park, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Australia
  • Sydney Adventist Hospital — Wahroonga, Australia
  • Princess Alexandra Hospital — Woolloongabba, Australia
  • AZORG campus Aalst Moorselbaan — Aalst, Belgium
  • 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
  • Hospital Samaritano de Sao Paulo — São Paulo, Brazil
  • British Columbia Cancer Agency — Vancouver, British Columbia, Canada
  • British Columbia Cancer Agency Vancouver Island Centre — Victoria, British Columbia, Canada
  • 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 Cancer Hospital — Beijing, China
  • Beijing Luhe Hospital, Capital Medical University — Beijing, China
  • The Third People's Hospital of Chengdu — Chengdu, China
  • West China Hospital Sichuan University — Chengdu, China
  • Chongqing University Cancer Hospital — Chongqing, China
  • Sun Yat Sen University Cancer Center — Guangzhou, China
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China
  • Nanjing Drum Tower Hospital — Nanjing, China
  • Huashan Hospital Fudan University — Shanghai, China
  • Shanghai General Hospital — Shanghai, China
  • Xinhua hospital,Shanghai Jiaotong University — Shanghai, 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
  • Institut Bergonie — Bordeaux, France
  • Centre Jean Perrin — Clermont-Ferrand, France
  • Centre Oscar Lambret — Lille, France
  • Centre Leon Berard — Lyon, France
  • Groupe Hospitalo-Universitaire Carémeau — Nîmes, France
  • Hopital Europeen Georges-Pompidou — Paris, France
  • Centre Eugene Marquis — Rennes, France
  • Gustave Roussy — Villejuif, France
  • Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
  • Urologicum Duisburg — Duisburg, Germany
  • Universitaetsklinikum Essen — Essen, Germany
  • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie — Hamburg, Germany
  • Klinikum rechts der Isar an der Technischen Universitat Munchen — München, Germany
  • Studienpraxis Urologie Drs. Feyerabend — Nürtingen, Germany
  • Azienda Ospedaliero Universitaria Careggi — Florence, Italy
  • ASL Napoli 2 Nord-SM delle Grazie Hospital — Localita La Schiana Pozzuoli, Italy
  • IRCCS Ospedale San Raffaele — Milan, Italy
  • Istituto Europeo di Oncologia — Milan, Italy
  • Istituto Nazionale Tumori Regina Elena — Roma, Italy
  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino — Torino, Italy
  • Juntendo University Hospital — Bunkyō City, Japan
  • Kansai Medical University Hospital — Hirakata, Japan
  • Kanazawa University Hospital — Kanazawa, Japan
  • Kobe University Hospital — Kobe, Japan
  • Kitasato University Hospital — Sagamihara, Japan
  • Shizuoka Cancer Center — Sunto Gun, Japan
  • Yokohama City University Medical Center — Yokohama, Japan
  • Hospital Wanita dan Kanak-Kanak Sabah — Kota Kinabalu, Malaysia
  • Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
  • Pantai 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. Germans Trias I Pujol — Badalona, Spain
  • Hosp. Univ. Ramon Y Cajal — Madrid, Spain
  • 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
  • Adana City Hospital — Adana, Turkey (Türkiye)
  • 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
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Official Source

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

View Official Record