NCT07225946

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostatic Neoplasms, Castration-Resistant

Interventions

Type	Name	Description
DRUG	Pasritamig	Pasritamig will be administered.
DRUG	Docetaxel	Docetaxel will be administered.
DRUG	Prednisone	Prednisone will be administered.

Timeline

• Start date: 2025-12-19
• Primary completion: 2027-11-19
• Completion: 2029-07-20
• First posted: 2025-11-10
• Last updated: 2026-04-14

Locations

97 sites across 15 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Japan, Malaysia, Puerto Rico, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study