Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
177Lu-TLX591 · 1 trial · 1 indication
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...
177Lu-TLX591 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in combination with standard of care therapy versus standard of care alone in patients with mCRPC.
177Lu-TLX591 targets PSMA, or prostate-specific membrane antigen, a protein highly expressed on prostate cancer cells. By binding to PSMA, the drug is designed to deliver a radioactive payload, lutetium-177, directly to the tumor cells. This targeted approach aims to damage cancer cells while sparing normal tissues.
177Lu-TLX591 is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. Telix is conducting a Phase 3 clinical trial of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer.
177Lu-TLX591 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The ongoing Phase 3 trial is actively recruiting participants to evaluate the drug's efficacy and safety in patients with metastatic castration-resistant prostate cancer.
177Lu-TLX591 is being studied in the ProstACT Global trial, registered as NCT06520345. This Phase 3, randomized, active-controlled study is recruiting 520 male patients aged 18 years and older with metastatic castration-resistant prostate cancer. The trial is being conducted in the United States, Australia, Canada, New Zealand, Turkey, and the United Kingdom.
177Lu-TLX591 is the lutetium-177 radiolabeled form of the investigational compound TLX591. The drug is being developed by Telix Pharmaceuticals for the treatment of metastatic castration-resistant prostate cancer. It is currently in Phase 3 clinical trials and has not been approved for commercial use.