A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With 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
Janssen Research & Development, LLC
800 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
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) 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).
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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
Interventions
Pasritamig will be administered.
Docetaxel will be administered.
Prednisone will be administered.
Locations(53)
View Full Details on ClinicalTrials.gov
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NCT07225946