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

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

Phase 3 Interventional Janssen Research & Development, LLC · NCT07225946

This trial tests whether adding pasritamig to standard docetaxel chemotherapy helps men with metastatic castration-resistant prostate cancer stay progression-free on scans longer than docetaxel alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionschemotherapy
Locations117 sites (Chandler, Arizona and 116 other locations)
Trial IDNCT07225946 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men with metastatic castration-resistant prostate cancer who have progressed after at least one androgen receptor pathway inhibitor, are receiving androgen deprivation therapy or have had bilateral orchiectomy with testosterone ≤50 ng/dL, and have ECOG performance status 0–1 are the intended participants.

Not a fit: Patients with known brain or leptomeningeal metastases, those with known BRCA1/2 mutations, poor performance status, or who do not meet the prior ARPI progression criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, adding pasritamig could prolong the time before cancer progression on scans and delay the need for further therapies.

How similar studies have performed: Combining novel targeted agents with docetaxel has produced mixed results in prostate cancer, and pasritamig is a novel agent with limited large-phase published data to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* Have histologically confirmed adenocarcinoma of the prostate
* Have disease that is metastatic at the time of the screening 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 milliliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening
* Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received 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) because the natural history or treatment could interfere with study endpoints
* Received cytotoxic chemotherapy for prostate cancer in any setting
* Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Where this trial is running

Chandler, Arizona and 116 other locations

+67 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostatic Neoplasms, Castration-Resistant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.