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

Study acronym: KLK2-PASenger
StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 152 → 158 locations
    • Study completion pushed from Jul 20, 2029 to Jun 7, 2030
    • Interventions: Docetaxel (Drug), Pasritamig (Drug), Prednisone/Prednisolone (Drug) to Docetaxel (Drug), Pasritamig (Drug), Prednisone/Prednisolone (Drug)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 12 of 20 entries
  2. Study sites: 150 to 152v11
  3. Primary endpoint(s) modifiedv10 Show 4 more changesShow less
    • Trial sites expanded: 136 → 150 locations
    • Interventions: Docetaxel (Drug), Pasritamig (Drug), Prednisone (Drug) to Docetaxel (Drug), Pasritamig (Drug), Prednisone/Prednisolone (Drug)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 7 of 20 entries
  4. Trial sites expanded: 117 → 136 locationsv9
  5. Trial sites expanded: 97 → 117 locations
    • Secondary endpoints: details revised at 1 of 20 entries
    v8
  6. Trial sites expanded: 53 → 97 locations
    • Secondary endpoints revised (20)
    v7
  7. Study sites: 30 to 53
    • Study completion date: Jun 20, 2029 to Jul 20, 2029
    v6
  8. Study sites: 13 to 30v5
  9. Study sites: 4 to 13
    • Start date changed from estimate of Jan 7, 2026 to Dec 19, 2025
    v4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    v3
  11. Study completion date: Jun 20, 2030 to Jun 20, 2029
    • Start date: Jan 15, 2026 to Jan 7, 2026
    • Secondary endpoints: details revised at 1 of 20 entries
    v2
  12. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07225946
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Prostatic Neoplasms, Castration-Resistant
Related terms Prostatic Neoplasms, Castration-Resistant
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov