Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study

Background: Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, demonstrated testosterone suppression to castrate levels in men with advanced prostate cancer (PCa) in the HERO study. Since advanced PCa and its treatments can impact patients' daily life, it is imperative to understand the impact of systemic therapy on patient health-related quality of life (HRQOL). Objective: To report the HRQOL for patients on relugolix compared with those on leupro-lide in on-treatment and testosterone recovery periods of the HERO study. Design, setting, and participants: A phase 3 randomized controlled study was conducted in 934 patients with advanced PCa.Intervention: Patients underwent 2:1 randomization and received relugolix 120 mg orally once daily or leuprolide 3-mo injections for 48 wk. Testosterone recovery was evaluated in a patient subset. Outcome measurements and statistical analysis: HRQOL evaluations were based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) and the Prostate Cancer Module (EORTC QLQ-PR25) during treatment and testosterone recovery phases. In a post hoc analysis, predictors of HRQOL deterioration were evaluated. Results and limitations: No statistically significant differences between the two groups were found in changes from baseline to the end of treatment in either the EORTC QLQ-C30 or the EORTC QLQ-PR25 instrument. During the testosterone recovery phase, hormonal treatment-related symptoms scores were lower for relugolix than for leupro-lide, suggesting a lower burden of hormone-related symptoms associated with a treat-ment that has more rapid testosterone recovery after treatment cessation. Limitations include low patient numbers in the testosterone recovery group.