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

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 (radiographi

Trial Details

NCT ID
NCT07365995
Phase
PHASE3
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • BNT324
  • Docetaxel
  • Prednisone/prednisolone
Locations (sample)
  • Santa Barbara, California, United States|34.42083,-119.69819
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Fort Myers, Florida, United States|26.62168,-81.84059
  • St. Petersburg, Florida, United States|27.77086,-82.67927
  • West Palm Beach, Florida, United States|26.71534,-80.05337

Key Eligibility Criteria

  • Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
  • Must have documented progressive prostate cancer based on at least one of the following criteria:
  • Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured seque…
  • Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

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