VISION: An International Prospective Open Label Multicenter Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed. The study is open-label and patients will be monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events. A long-term follow-up period will include the collection of survival and treatment updates, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (?1 month) via phone, email, or letter for 24 months or until the the overall censoring rate for survival reduces to a level identified in the SAP. An End of Treatment visit should occur once a patient is to enter the long term follow up. This visit should occur approximately 30 days from the last dose of 177Lu-PSMA-617 or best supportive/best standard of care, but before the initiation of subsequent anti-cancer treatment, outside of what is allowed on study. The planned enrollment for this study is 750 patients.

Participants will not be paid for their participation.

Participants will not be paid for their participation.