Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

Exclusion criteria

• . Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
• . Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to day of randomization.
• . Any investigational agents within 28 days prior to day of randomization.
• . Known hypersensitivity to the components of the study therapy or its analogs.
• . Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
• . Transfusion for the sole purpose of making a subject eligible for study inclusion.
• . Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
• . A superscan as seen in the baseline bone scan.