Clinical trial Recruiting at 171 sites Phase 3 Interventional Ages 18 and up Men only

Pasritamig versus placebo for late-line metastatic castration-resistant prostate cancer

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer

Run by Janssen Research & Development, LLC · NCT07164443 · Data updated 2026-11-12

This will test whether pasritamig plus best supportive care helps people with late-line metastatic castration-resistant prostate cancer live longer than placebo plus supportive care.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment1203 (estimated)
SponsorJanssen Research & Development, LLC
Industry-sponsored
Drugs / interventionsmethotrexate
Locations176 sites (La Jolla, California and 175 other locations)
StatusRecruiting
StartedSeptember 2, 2025
Main results expectedAugust 18, 2028
Study endsAugust 18, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT07164443 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with histologically confirmed prostate adenocarcinoma and metastatic castration-resistant disease (PSA ≥2 ng/mL) who have progressed on prior androgen-receptor pathway inhibitors and have received all available life-prolonging therapies and for whom a clinical trial is the next best option.

Probably not a fit

Patients with non-adenocarcinoma prostate cancers, those who have not yet received appropriate prior life-prolonging therapies, or those unable to travel to or tolerate investigational treatments are unlikely to benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 3 trial compares pasritamig (JNJ-78278343) plus best supportive care to placebo plus best supportive care in people with metastatic castration-resistant prostate cancer who have progressed after standard therapies. The primary endpoint is overall survival, with participants randomized to receive pasritamig or placebo alongside supportive measures. Eligible participants must have histologically confirmed prostate adenocarcinoma, metastatic disease on conventional imaging, PSA ≥2 ng/mL, and have received all life‑prolonging therapies for which they are eligible. The study is sponsored by Janssen and is being conducted at multiple U.S. cancer centers.

Why it matters

Potential benefit: If effective, pasritamig could extend overall survival for patients with late-line mCRPC.

How similar studies have gone: Some other late-line therapies for mCRPC have shown modest survival benefits, but pasritamig is a novel agent and this Phase 3 trial aims to confirm signals seen in earlier studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of California at San Diego
    La Jolla, California, United States
    Recruiting
  • Cedars Sinai Medical Center
    Los Angeles, California, United States
    Recruiting
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, United States
    Recruiting
  • San Francisco VA Medical Center
    San Francisco, California, United States
    Recruiting
  • Rocky Mountain Cancer Centers
    Aurora, Colorado, United States
    Recruiting
  • University of Colorado Cancer Center
    Aurora, Colorado, United States
    Recruiting
Show 44 more locations
  • Colorado Clinical Research
    Lakewood, Colorado, United States
    Recruiting
  • Hartford Hospital
    Hartford, Connecticut, United States
    Recruiting
  • Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • Bay Pines VA Healthcare System
    Bay Pines, Florida, United States
    Recruiting
  • Florida Cancer Specialists & Research Institute
    Fort Myers, Florida, United States
    Recruiting
  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting
  • University of Iowa Hospital and Clinics
    Iowa City, Iowa, United States
    Recruiting
  • Mission Cancer Blood
    Waukee, Iowa, United States
    Recruiting
  • East Jefferson General Hospital
    Metairie, Louisiana, United States
    Recruiting
  • Johns Hopkins University
    Baltimore, Maryland, United States
    Recruiting
  • Dana Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • University of Michigan Health System
    Ann Arbor, Michigan, United States
    Recruiting
  • Henry Ford Cancer Detroit
    Detroit, Michigan, United States
    Recruiting
  • University Of Minnesota Medical Center
    Minneapolis, Minnesota, United States
    Recruiting
  • NYU Langone Hospitals
    Brooklyn, New York, United States
    Recruiting
  • 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
  • Columbia University Medical Center
    New York, New York, United States
    Recruiting
  • Levine Cancer Institute
    Charlotte, North Carolina, United States
    Recruiting
  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
    Winston-Salem, North Carolina, United States
    Recruiting
  • University of Cincinnati
    Cincinnati, Ohio, United States
    Recruiting
  • University Hospital of Cleveland
    Cleveland, Ohio, United States
    Recruiting
  • Oregon Health And Science University
    Portland, Oregon, United States
    Recruiting
  • VA Portland Health Care System
    Portland, Oregon, United States
    Recruiting
  • Oregon Urology Institute
    Springfield, Oregon, United States
    Recruiting
  • MidLantic Urology
    Bala-Cynwyd, Pennsylvania, United States
    Recruiting
  • Keystone Urology Specialists
    Lancaster, Pennsylvania, United States
    Recruiting
  • Penn Medicine Abramson Cancer Center
    Philadelphia, Pennsylvania, United States
    Recruiting
  • UPMC Cancer Centers
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Ralph H Johnson Veterans Hospital
    Charleston, South Carolina, United States
    Recruiting
  • Gibbs Cancer Center and Research Institute Pelham
    Greer, South Carolina, United States
    Recruiting
  • Carolina Urologic Research Center
    Myrtle Beach, South Carolina, United States
    Recruiting
  • Gibbs Cancer Center
    Spartanburg, South Carolina, United States
    Recruiting
  • Tennessee Oncology - Chattanooga
    Chattanooga, Tennessee, United States
    Recruiting
  • Tennessee Oncology Nashville
    Nashville, Tennessee, United States
    Recruiting
  • UT Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • Michael E DeBakey VA Medical Center
    Houston, Texas, United States
    Recruiting
  • Texas Oncology West Texas
    Wichita Falls, Texas, United States
    Recruiting
  • Utah Cancer Specialists
    Salt Lake City, Utah, United States
    Recruiting
  • Virginia Cancer Specialists
    Fairfax, Virginia, United States
    Recruiting
  • Virginia Oncology Associates
    Norfolk, Virginia, United States
    Recruiting
  • Blue Ridge Cancer Care
    Roanoke, Virginia, United States
    Recruiting
  • VA Puget Sound Healthcare System
    Seattle, Washington, United States
    Recruiting

+126 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.