Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer.
A Multi-center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.
The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone or enzalutamide) respectively.
Inclusions/Exclusions: PD of measurable disease or at least 2 new bone lesions. Previous TX with AR-therapy. HIV, HBV, HCV allowed. ECOG 0-1. Stable brain metastasis allowed. No prior chemotherapy.