Pasritamig plus docetaxel versus docetaxel for metastatic castration‑resistant prostate cancer

Is this trial a fit for you?

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 plus docetaxel (with prednisone as indicated) versus docetaxel alone in men with metastatic castration-resistant prostate cancer (mCRPC). Participants must be on continuous androgen deprivation therapy or post-orchiectomy, have testosterone ≤50 ng/dL, have progressed on at least one novel androgen receptor pathway inhibitor, and have ECOG performance status 0–1. The primary endpoint is radiographic progression-free survival (rPFS), defined as time from treatment start until disease worsening on scans, with key secondary endpoints likely including overall survival and safety. The trial is sponsored by Janssen and enrolling at sites in Arizona, Arkansas, and California.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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

Exclusion criteria:

* 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's running

• Arizona Clinical Trials
  Chandler, Arizona, United States Recruiting
• Arkansas Urology
  Little Rock, Arkansas, United States Recruiting
• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• MemorialCare Orange Coast Medical Center
  Fountain Valley, California, United States Recruiting
• University Of California San Diego
  La Jolla, California, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting

+115 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

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.