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A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 30 → 33 locations Interventions: BNT324 (Drug), Docetaxel (Drug), Prednisone/prednisolone (Drug) to BNT324 (Drug), Docetaxel (Drug), Prednisone/prednisolone (Drug) · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 8 of 10 entries · 1 more Show 4 more changesShow less
    • Interventions: BNT324 (Drug), Docetaxel (Drug), Prednisone/prednisolone (Drug) to BNT324 (Drug), Docetaxel (Drug), Prednisone/prednisolone (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 8 of 10 entries
    • Study description revised
  2. Trial sites expanded: 15 → 30 locationsv5
  3. Trial sites expanded: 9 → 15 locationsv4
  4. Trial sites expanded: 5 → 9 locationsv3
  5. Recruitment opened Trial sites expanded: 0 → 5 locations · Start date changed from estimate of Mar 2026 to Apr 22, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of Mar 2026 to Apr 22, 2026
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
BioNTech SE
49 trials monitored
See 3 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC. The main goals of this study are: * To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \[rPFS\]). * To find out if BNT324 helps participants live longer overall (overall survival \[OS\]).
Trial Details
NCT Number NCT07365995
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd., DualityBio Inc.
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 736 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov