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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06520345 | The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) | PHASE3 | RECRUITING | 520 | — | — | Jul 26, 2024 | Dec 1, 2030 | May 27, 2026 | 31 | United States, Australia +4 |
time from randomization to disease progression confirmed by central independent radiology review according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (which incorporates Response Evaluation Criteria in Solid Tumors, RECIST 1.1, for soft tissue lesions), or death (whichever occurs first)
| Arm | Type | Description |
|---|---|---|
| 177Lu-TLX591 + Enzalutamide or Abiraterone or Docetaxel | EXPERIMENTAL | Lutetium (177Lu) rosopatamab tetraxetan (177Lu-TLX591) 76 mCi (±10%) given approximately 14 days apart, plus SOC. SOC is either: Concurrent enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent. or Concurrent abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (5 mg once daily for the standard formulation), methylprednisolone (4 mg twice daily for the fine particle formulation) or dexamethasone (1 mg once daily) or Sequential Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone (5mg twice a day) or equivalent for up to 10 cycles. |
| Control Arm (Enzalutamide or Abiraterone or Docetaxel) | ACTIVE_COMPARATOR | SOC is either: Enzalutamide (starting dose 160 mg daily). or Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg once daily for the standard formulation) or Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone 5mg twice a day (or equivalent) for up to 10 cycles |
| Name | Type | Description |
|---|---|---|
| 177Lu-TLX591 | DRUG | Participants randomized to Group A will receive two 76 mCi (±10%) doses of 177Lu-TLX591 14 days apart |
| Enzalutamide | DRUG | Enzalutamide (starting dose 160 mg daily) |
| Abiraterone | DRUG | Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg per day for the standard formulation) |
| Docetaxel | DRUG | Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone 5mg twice a day (or equivalent) for up to 10 cycles |
Inclusion Criteria: * Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological / pathological confirmation. * Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months from Day 1. * Have metastatic disease (defined as...