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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1203 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 176 sites (La Jolla, California and 175 other locations) |
| Status | Recruiting |
| Started | September 2, 2025 |
| Main results expected | August 18, 2028 |
| Study ends | August 18, 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07164443 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
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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
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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
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.