A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Metastatic Castration-resistant Prostate Neoplasms

In brief

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 combination with best supportive care (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).

Key facts

Study ID

NCT07164443

Run by

Janssen Research & Development, LLC

People needed

1203

Starts

2025-09-02

Expected to finish

2028-08-18

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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 should 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: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:
• Cabazitaxel is not available
• 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. Participants who cannot continue taxane therapy because of a documented Grade>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment
• Radioligand therapy: Should 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:
• PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
• The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.
• Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should 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 >= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin <= 3 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

You may not qualify if…

• 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 is running

• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Colorado Clinical Research — Lakewood, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States (enrolling)
• Florida Cancer Specialists & Research Institute — Fort Myers, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (enrolling)
• Mission Cancer Blood — Waukee, Iowa, United States (enrolling)
• East Jefferson General Hospital — Metairie, Louisiana, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Cancer Detroit — Detroit, Michigan, United States (enrolling)
• University Of Minnesota Medical Center — Minneapolis, Minnesota, United States (enrolling)
• XCancer Omaha / Urology Cancer Center — Omaha, Nebraska, United States (enrolling)
• NYU Langone Hospitals — Brooklyn, New York, United States (enrolling)
• NYU Langone Hospital Long Island — Mineola, New York, United States (enrolling)
• NYU Langone Health Laura and Isaac Perlmutter Cancer Center — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• University of California at San Diego — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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