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

Part of paid clinical trials in Rockville, Maryland.

Sponsor
BioNTech SE
Study ID
NCT07365995
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT324 — DRUG
    Intravenous infusion
  • Docetaxel — DRUG
    Intravenous infusion
  • Prednisone/prednisolone — DRUG
    Oral

Study Details

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 \[OS\]).

Key Dates

Start date
Apr 22, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
736 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BNT324
  • Active Comparator: Docetaxel plus prednisone/ prednisolone

Primary Outcome Measure

rPFS assessed by BICR [ Time Frame: From randomization to end of study, i.e., up to 58 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Maryland Oncology HematologyRockvilleMaryland20850-
SCRI Oncology PartnersNashvilleTennessee37203-
Texas Oncology South AustinAustinTexas78731-
Texas Oncology Gulf CoastHoustonTexas77024-
Texas Oncology, P.A. - TylerTylerTexas75702-

Find similar trials in Rockville, MD

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Prostate cancer
By specialty
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By research site
Maryland Oncology Hematology· Rockville, MDSCRI Oncology Partners· Nashville, TNTexas Oncology South Austin· Austin, TXTexas Oncology Gulf Coast· Houston, TXTexas Oncology, P.A. - Tyler· Tyler, TX

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