NCT07164443From ClinicalTrials.govRecruiting

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

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

Metastatic Castration-resistant Prostatic Neoplasms

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 1,203
Started: 2 September 2025
Main results due: 18 August 2028
Study sites: 174
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Men only.
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

* 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

What this study is about

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

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Study sites(174)

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
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
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 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
Compass Oncology
Portland, Oregon, United States
Completed
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
Urology Clinics of North Texas
Dallas, Texas, United States
Completed
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
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Recruiting
University of Washington
Seattle, Washington, United States
Recruiting
Warringal Private Hospital
Heidelberg, Australia
Recruiting
ICON Cancer Care
Kurralta Park, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Australia
Recruiting
Fiona Stanley Hospital
Murdoch, Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba, Australia
Recruiting
AZ Sint-Jan
Bruges, Belgium
Recruiting

Showing 60 of 174 sites — filter to narrow it down. 171 of the 174 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 NCT07164443. 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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