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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07550517 | PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT | PHASE2 | NOT YET_RECRUITING | 60 | — | — | Apr 1, 2026 | Apr 1, 2033 | Apr 24, 2026 | 1 | United States |
The rate of testosterone recovery (TR) will be determined by the percentage of patients who recover normal T levels within 3 years after randomization.
| Arm | Type | Description |
|---|---|---|
| Arm A (EBRT + 6 mo ADT + 177Lu-PSMA-617) | EXPERIMENTAL | Participants will receive EBRT + 6 mo ADT + 177Lu-PSMA-617 |
| Arm B (EBRT + 24 mo ADT) | ACTIVE_COMPARATOR | Participants will receive EBRT + 24 mo ADT |
| Name | Type | Description |
|---|---|---|
| EBRT + 6 mo ADT + 177Lu-PSMA-617 | DRUG | In Arm A, 177Lu-PSMA-617 will be given as intravenous infusion every 6 weeks, up to 4 cycles. Cycle 1 Day 1 (C1D1) of 177Lu-PSMA-617 will start at least 2 weeks after ADT, and EBRT will start at least 2 weeks after C1D1. |
| EBRT + 24 mo ADT | RADIATION | In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT. |
Inclusion Criteria: * Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \> 20 ng/mL. * Histologic confirmation of adenocarcinoma of the prostate. * Patient must have localized HRPC defined by conventional imagi...