Safety Analyses of the Phase 3 VISION Trial of [¹⁷⁷Lu]Lu-PSMA-617 in Patients with Metastatic Castration-resistant Prostate Cancer.

ABSTRACT:

Background and objective

[¹⁷⁷Lu]Lu-PSMA-617 (¹⁷⁷Lu-PSMA-617) plus the standard of care (SoC) significantly improved overall survival and radiographic progression-free survival versus SoC alone in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer in the VISION trial. We evaluated the safety of additional cycles of ¹⁷⁷Lu-PSMA-617 and the impact of longer observation time for patients receiving ¹⁷⁷Lu-PSMA-617 plus SoC.

Methods

VISION was an international, open-label study. Patients were randomised 2:1 to receive ¹⁷⁷Lu-PSMA-617 plus SoC or SoC alone. The incidence of treatment-emergent adverse events (TEAEs) was assessed in prespecified subgroups of patients who

SUBMITTER: Chi KN 

PROVIDER: S-EPMC11859717 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature