At a glance
ClinicalIndex Comparison Record- ✓Male, at least 18 years old with histologically confirmed prostate adenocarcinoma
- ✓ECOG performance status 0, 1, or 2 with estimated life expectancy ≥6 months
- ✓Metastatic disease with ≥1 metastatic lesion on baseline imaging
- ✓Castration-resistant prostate cancer with castrate testosterone <50 ng/dL or <1.7 nmol/L at screening
- ✕Prostate cancer with pathology other than adenocarcinoma, except minor (<20%) neuroendocrine elements allowed
- ✕History of other malignancies that could impact life expectancy or disease assessment, with exceptions
- ✕Prior treatment with monoclonal antibody J591, HuJ591, or any other PSMA-targeted therapy
- ✕Prior chemotherapy in mCRPC or nmCRPC settings
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment
In Brief
A Phase 3 clinical trial evaluating 177Lu-TLX591, Enzalutamide, and 2 other interventions for Metastatic Castration-resistant Prostate Cancer. Currently recruiting, targeting 520 participants across 31 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment
Study Details
Timeline
Interventions
Participants randomized to Group A will receive two 76 mCi (±10%) doses of 177Lu-TLX591 14 days apart
Enzalutamide (starting dose 160 mg daily)
Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg per day for the standard formulation)
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