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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04689828 | 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 469 | — | — | Jun 15, 2021 | Sep 30, 2026 | Mar 23, 2026 | 72 | United States, Austria +12 |
| NCT04720157 | An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) | PHASE3 | ACTIVE NOT_RECRUITING | 1,140 | — | — | Jun 9, 2021 | Feb 11, 2027 | Jun 8, 2026 | 167 | United States, Austria +17 |
rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
| Arm | Type | Description |
|---|---|---|
| 177Lu-PSMA-617 | EXPERIMENTAL | Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used. |
| Androgen receptor-directed therapy (ARDT) | ACTIVE_COMPARATOR | For participants randomized to the ARDT arm, abiraterone or enzalutamide was administered per the physician's orders. Best supportive care, including Androgen deprivation therapy (ADT) could be used. |
| Standard of Care | ACTIVE_COMPARATOR | For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order |
| Name | Type | Description |
|---|---|---|
| 177Lu-PSMA-617 | DRUG | administered intravenously once every 6 weeks (1 cycle) for 6 cycles |
| 68Ga-PSMA-11 | DRUG | single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi). |
| ARDT | DRUG | administered orally on a continuous basis, as per package insert and guidelines |
| ADT | DRUG | ADT are administered as per physician order |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participants must be adults \>= 18 years of age. * Participants must have an ECOG performance status of 0 to 1. * Participants must have histological pathological, and/or cytological confirmation o...