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

Last updated: March 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Pasritamig

Docetaxel

Prednisone

Clinical Study ID

NCT07225946
78278343PCR3003
2025-522713-29-00
78278343PCR3003
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion criteria:

  • Have histologically confirmed adenocarcinoma of the prostate

  • Have disease that is metastatic at the time of the screening as determined by theinvestigator

  • Participants must receive ongoing androgen deprivation therapy (ADT) with agonadotropin releasing hormone (GnRH) analog throughout the treatment or have hadprior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per milliliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) atscreening

  • Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) butreceived no more than 2 different ARPI for any stage of disease. Must havediscontinued ARPI before randomization into the study

  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion

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 orsomatic) 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) becausethe natural history or treatment could interfere with study endpoints

  • Received cytotoxic chemotherapy for prostate cancer in any setting

  • Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Study Design

Total Participants: 800
Treatment Group(s): 3
Primary Treatment: Pasritamig
Phase: 3
Study Start date:
December 19, 2025
Estimated Completion Date:
July 20, 2029

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  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037
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  • Icon Cancer Centre Kurralta Park

    Kurralta Park 8348005, 5037
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    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, 3000
    Australia

    Site Not Available

  • Sydney Adventist Hospital

    Wahroonga, 2076
    Australia

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  • NAIC Nair Antunes Instituto do Cancer

    Bauru, 17033-495
    Brazil

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  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000
    Brazil

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  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 870
    Brazil

    Active - Recruiting

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André 3449701, 09060 870
    Brazil

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Site Not Available

  • Centre de Recherche du CHUM

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • CHU de Quebec Universite Laval

    Québec, Quebec G1R 2J6
    Canada

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  • CHU de Quebec Universite Laval

    Québec 6325494, Quebec 6115047 G1R 2J6
    Canada

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa, 920 8641
    Japan

    Active - Recruiting

  • Kitasato University Hospital

    Sagamihara, 252-0375
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024
    Japan

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  • Yokohama City University Medical Center

    Yokohama 1848354, 232 0024
    Japan

    Site Not Available

  • Hospital Wanita dan Kanak-Kanak Sabah

    Kota Kinabalu, 88996
    Malaysia

    Active - Recruiting

  • Hospital Wanita dan Kanak-Kanak Sabah

    Kota Kinabalu 1733432, 88996
    Malaysia

    Site Not Available

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    Kuala Lumpur, 50586
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    Kuala Lumpur, 59100
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    Kuala Lumpur 1735161, 50586
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  • University Malaya Medical Centre

    Kuala Lumpur 1735161, 59100
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  • Hospital Umum Sarawak

    Kuching, 93586
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  • Hospital Umum Sarawak

    Kuching 1735634, 93586
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    San Juan, 935
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    San Juan 4568127, 935
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  • Samsung Medical Center

    Seoul, 06351
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  • China Medical University Hospital

    Taichung, 404
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    Taichung, 407219
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  • China Medical University Hospital

    Taichung 1668399, 404
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    Taoyuan District, 333
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  • Linkou Chang Gung Memorial Hospital

    Taoyuan District 1667905, 333
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    Ankara, 06100
    Turkey (Türkiye)

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    Ankara, 06010
    Turkey (Türkiye)

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  • Istanbul University Cerrahpasa tip Fakultesi

    Istanbul, 34096
    Turkey (Türkiye)

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  • Koc Universitesi Hastanesi

    Istanbul, 34147
    Turkey (Türkiye)

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  • Medicana International Izmir

    Izmir, 35170
    Turkey (Türkiye)

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  • Beatson West Of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

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  • Beatson West Of Scotland Cancer Centre

    Glasgow 2648579, G12 0YN
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    Site Not Available

  • St Bartholomews Hospital

    London, EC1A 7BE
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  • The Royal Marsden NHS Trust

    London, SW3 6JJ
    United Kingdom

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  • St Bartholomews Hospital

    London 2643743, EC1A 7BE
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    Site Not Available

  • The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

    Newcastle upon Tyne, NE7 7DN
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  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

    Preston, PR2 9HT
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  • Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    Sutton 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • Arkansas Urology

    Little Rock, Arkansas 72211
    United States

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  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

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  • Kaiser Permanente Southern California

    Riverside, California 92505
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles 5368361, California 5332921 90067
    United States

    Site Not Available

  • Kaiser Permanente Southern California

    Riverside 5387877, California 5332921 92505
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    Site Not Available

  • Grand Valley Oncology

    Grand Junction, Colorado 81505
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  • Colorado Clinical Research

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Duly Health and Care

    Lisle, Illinois 60532
    United States

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  • Cancer Center of Kansas Heritage Plaza Medical Building

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Cancer Center of Kansas Heritage Plaza Medical Building

    Wichita 4281730, Kansas 4273857 67214
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    Site Not Available

  • East Jefferson General Hospital

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • East Jefferson General Hospital

    Metairie 4333177, Louisiana 4331987 70006
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  • Profound Research LLC at Cancer and Leukemia Center

    Sterling Heights, Michigan 48314
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  • Profound Research LLC at Cancer and Leukemia Center

    Sterling Heights 5011148, Michigan 5001836 48314
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    Site Not Available

  • HealthPartners Frauenshuh Cancer Center CRC West

    Saint Louis Park, Minnesota 55426
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  • HealthPartners Cancer Center at Regions Hospital CRC East

    Saint Paul, Minnesota 55101
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  • HealthPartners Frauenshuh Cancer Center CRC West

    Saint Louis Park 5045021, Minnesota 5037779 55426
    United States

    Site Not Available

  • HealthPartners Cancer Center at Regions Hospital CRC East

    Saint Paul 5045360, Minnesota 5037779 55101
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  • NHO Revive Research Institute, LLC

    Lincoln, Nebraska 68506
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  • NHO Revive Research Institute, LLC

    Lincoln 5072006, Nebraska 5073708 68506
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    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
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  • Oregon Urology Institute

    Springfield, Oregon 97477
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  • Oregon Urology Institute

    Springfield 5754005, Oregon 5744337 97477
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  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania 19004
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  • MidLantic Urology

    Bala-Cynwyd 5178892, Pennsylvania 6254927 19004
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  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
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  • Carolina Urologic Research Center

    Myrtle Beach 4588718, South Carolina 4597040 29572
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  • Avera Medical Group

    Sioux Falls, South Dakota 57105
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  • Avera Medical Group

    Sioux Falls 5231851, South Dakota 5769223 57105
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  • Houston Metro Urology

    Houston, Texas 77027
    United States

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  • Houston Metro Urology

    Houston 4699066, Texas 4736286 77027
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  • Fred Hutch Cancer Center Sloan Clinic 2

    Seattle, Washington 98109
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  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

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  • Fred Hutchinson Cancer Research Center

    Seattle 5809844, Washington 5815135 98109
    United States

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