A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
← catalyst calendarNCT07365995 · readout ≤ 1,654 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With BioNTech (Shanghai) Pharmaceuticals Co., Ltd., DualityBio Inc..
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
736estimated
Sites
15
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-22 | actual | When the study began enrolling |
| Primary completion | Feb 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Castration-resistant Prostate Cancer
Interventions
- Drug: BNT324 — also filed as DB-1311
- Drug: Docetaxel
- Drug: Prednisone/prednisolone
Primary outcomes
what the primary-completion date above is the date OFrPFS assessed by BICR
measured From randomization to end of study, i.e., up to 58 months
OS
measured From randomization to end of study, i.e., up to 58 months
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