Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07365995 | A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer | PHASE3 | RECRUITING | 736 | — | — | Apr 22, 2026 | Feb 1, 2031 | May 5, 2026 | 5 | United States |
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
By arm. OS is defined as time from randomization to death from any cause.
| Arm | Type | Description |
|---|---|---|
| BNT324 | EXPERIMENTAL | - |
| Docetaxel plus prednisone/ prednisolone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BNT324 | DRUG | Intravenous infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Prednisone/prednisolone | DRUG | Oral |
Key Inclusion 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 progressio...