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

Summary

Participation Requirements

Description

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 bu...

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 rPFS survival and information about new treatments, responses to new treatments, 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 508 deaths have occurred. An End of Treatment visit should occur once a patient discontinues the treatment part of the study for any reason (patient or investigator decision, going on to long term follow up, etc.). This visit should occur approximately 30 days from the last dose of 177Lu-PSMA-617 or the date of the best supportive/best standard of care end of treatment decision (whichever occurs later), but before the initiation of subsequent anti-cancer treatment, outside of what is allowed on study. The planned enrollment for this study is 814 patients. A dosimetry, PK and ECG sub-study will be conducted in a non-randomized cohort (177Lu-PSMA-617 plus best supportive/best standard of care) of approximately 30 patients at sites in Germany to provide a more complete assessment of the safety aspects of 177Lu-PSMA-617. In order to not bias the results obtained from randomized patients in the main study, the data of the sub-study patients will be analyzed descriptively and not considered in the primary and secondary analysis of the main study.

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