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NCT07225946From ClinicalTrials.govRecruiting

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

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

  • Prostatic Neoplasms, Castration-Resistant

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
800
Started
19 December 2025
Main results due
19 November 2027
Study sites
158
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(158)

  • Arizona Clinical Trials

    Chandler, Arizona, United States

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, United States

    Recruiting

  • MemorialCare Orange Coast Medical Center

    Fountain Valley, California, United States

    Recruiting

  • University Of California San Diego

    La Jolla, California, United States

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, United States

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, United States

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, United States

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, United States

    Recruiting

  • Kaiser Permanente Southern California

    Riverside, California, United States

    Recruiting

  • Sharp Center for Research

    San Diego, California, United States

    Recruiting

  • Providence Saint John s Health Center

    Santa Monica, California, United States

    Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, United States

    Recruiting

  • AdventHealth Porter Oncology Research

    Denver, Colorado, United States

    Recruiting

  • Vail Health Shaw Cancer Center

    Edwards, Colorado, United States

    Recruiting

  • Grand Valley Oncology

    Grand Junction, Colorado, United States

    Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado, United States

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, United States

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, United States

    Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, United States

    Recruiting

  • Duly Health and Care

    Lisle, Illinois, United States

    Recruiting

  • Cancer Center of Kansas Heritage Plaza Medical Building

    Wichita, Kansas, United States

    Recruiting

  • St Elizabeth Healthcare

    Edgewood, Kentucky, United States

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, United States

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, United States

    Recruiting

  • University of Maryland

    Baltimore, Maryland, United States

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

    Recruiting

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, United States

    Recruiting

  • Chesapeake Urology Research Associates

    Towson, Maryland, United States

    Recruiting

  • Massachusetts General

    Boston, Massachusetts, United States

    Recruiting

  • Profound Research LLC at Cancer and Leukemia Center

    Sterling Heights, Michigan, United States

    Recruiting

  • HealthPartners Frauenshuh Cancer Center CRC West

    Saint Louis Park, Minnesota, United States

    Recruiting

  • HealthPartners Cancer Center at Regions Hospital CRC East

    Saint Paul, Minnesota, United States

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, United States

    Recruiting

  • Washington University

    St Louis, Missouri, United States

    Recruiting

  • NHO Revive Research Institute, LLC

    Lincoln, Nebraska, United States

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, United States

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, United States

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, United States

    Recruiting

  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center

    New York, New York, United States

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, United States

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, United States

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, United States

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, United States

    Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, United States

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, United States

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, United States

    Recruiting

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, United States

    Recruiting

  • Avera Medical Group

    Sioux Falls, South Dakota, United States

    Recruiting

  • Prairie Lakes Health Care System

    Watertown, South Dakota, United States

    Recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, United States

    Recruiting

  • Texas Oncology

    Austin, Texas, United States

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, United States

    Recruiting

  • Houston Metro Urology

    Houston, Texas, United States

    Recruiting

  • Texas Oncology 1

    Sugar Land, Texas, United States

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texas, United States

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, United States

    Recruiting

  • Fred Hutch Cancer Center Sloan Clinic 2

    Seattle, Washington, United States

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States

    Recruiting

  • Warringal Private Hospital

    Heidelberg, Australia

    Recruiting

Showing 60 of 158 sites — filter to narrow it down. 158 of the 158 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07225946. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Pro | Trialion