177Lu-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.

Inclusion Criteria: 1. Male 18 years or older able to understand and provide signed written informed consent. 2. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component. 3. Progressive disease by one or more of the following criteria: 1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of \>2 ng/mL. 2. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria). 4. Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). 1. Must have received no more than one previous AR-directed therapy. 2. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting. 3. Must have progressed while on ARAT. 5. PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader. 6. Effective castration with serum testosterone level of \