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Also known as Lutetium (177Lu) rosopatamab tetraxetan, 177Lu-DOTA-rosopatamb
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 being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer that has spread beyond the prostate and no longer responds to androgen deprivation therapy. It is an investigational therapy and is being studied in combination with standard of care.
177Lu-TLX591 targets PSMA, or prostate-specific membrane antigen, a protein highly expressed on prostate cancer cells. The agent combines a PSMA-targeting small molecule with the radioisotope lutetium-177, delivering radiation to PSMA-expressing tumor cells. The trial enrolls biomarker-selected patients.
177Lu-TLX591 is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. Telix is the sponsor of the ongoing Phase 3 ProstACT Global study evaluating the agent in metastatic castration-resistant prostate cancer.
177Lu-TLX591 is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 ProstACT Global trial is currently recruiting participants and is designed to compare 177Lu-TLX591 plus standard of care versus standard of care alone.
177Lu-TLX591 is being evaluated in the Phase 3 ProstACT Global trial, registered as NCT06520345. The study is recruiting 520 male participants aged 18 years and older with metastatic castration-resistant prostate cancer across the United States, Australia, Canada, New Zealand, Turkey, and the United Kingdom.
Yes. The Phase 3 ProstACT Global trial of 177Lu-TLX591 is randomized and actively controlled, comparing 177Lu-TLX591 plus standard of care against standard of care alone. It is not double-blind. The study plans to enroll 520 patients with metastatic castration-resistant prostate cancer.