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

Recruiting now · Phase 3

Conditions studied: Prostatic Neoplasms, Castration-Resistant

In brief

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).

Key facts

Study ID

NCT07225946

Run by

Janssen Research & Development, LLC

People needed

800

Starts

2025-12-19

Expected to finish

2029-07-20

Last updated by the study team

2026-07-30

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
• MemorialCare Orange Coast Medical Center — Fountain Valley, California, United States (enrolling)
• University Of California San Diego — La Jolla, California, United States (enrolling)
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Kaiser Permanente Southern California — Riverside, California, United States (enrolling)
• Sharp Center for Research — San Diego, California, United States (enrolling)
• Providence Saint John s Health Center — Santa Monica, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States (enrolling)
• Vail Health Shaw Cancer Center — Edwards, Colorado, United States (enrolling)
• Grand Valley Oncology — Grand Junction, Colorado, United States (enrolling)
• Colorado Clinical Research — Lakewood, Colorado, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States (enrolling)
• Duly Health and Care — Lisle, Illinois, United States (enrolling)
• Cancer Center of Kansas Heritage Plaza Medical Building — Wichita, Kansas, United States (enrolling)
• St Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
• Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
• East Jefferson General Hospital — Metairie, Louisiana, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States (enrolling)
• Chesapeake Urology Research Associates — Towson, Maryland, United States (enrolling)
• Arizona Clinical Trials — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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