Optyx study: Clinical characteristics and preferences for initiating relugolix in a cohort of US patients in real-world care settings.

Abstract

67 Background: Relugolix is the only oral androgen deprivation therapy indicated for advanced prostate cancer (PC). The OPTYX study is the first prospective study to collect evidence on the long-term safety, effectiveness, treatment patterns, disease course, and patient outcomes with relugolix in real-world care. Enrollment is completed and this analysis assessed key baseline variables, reasons for starting relugolix, and treatment patterns. Methods: The multi-center observational OPTYX study enrolled men with PC starting relugolix across various disease stages and treatment regimens (e.g., mono or combination therapy). Enrollment occurred in diverse clinical settings including urology, oncology, and radiation oncology. Eligibility required intent to treat with relugolix for more than 4 months. Data collected included baseline demographics, clinical characteristics, reasons for initiating treatment, treatment patterns, and quality of life (FACT-P) questionnaires from Oct 2022 to Sept 2024. Results: By September 2024, 999 men were enrolled and received relugolix with a median treatment duration of 242 days. The median age was 71 years; 77.4% self-identified as White, 16.4% as Black. Over 80% submitted FACT-P questionnaires at baseline. Disease states included localized (42.0%), locally advanced (16.7%), biochemical recurrence (11.2%), metastatic castration sensitive PC (18.7%), non-metastatic (1.5%), metastatic castration resistant PC (4.8%), and unknown (5.0%). Of these, 476 men (47.7%) received relugolix in combination with other PC therapies including radiation and systemic therapies. Prior ADT was reported in 21.0% of patients. Mean (SD) baseline testosterone and PSA were 293.1 (227.8) ng/dL and 61.3 (342.4) ng/mL, respectively. The top reasons physicians prescribed relugolix were preference for oral over injection administration (41.5%), rapid testosterone suppression (34.6%), and safety (29.0%), while patients reported physician recommendation (72.3%), oral over injection (36.4%), and rapid testosterone recovery (10.2%). Conclusions: The OPTYX study enrolled 999 patients to assess real-world experience with relugolix. Nearly half started relugolix with other therapies. Many patients and physicians preferred the oral formulation, and other top reasons for initiation included safety and rapid testosterone suppression and recovery. Clinical trial information: NCT05467176 . Relugolix Initiation Preference n (%) By Physician By Patient Oral Instead of Injection 415 (41.5) 364 (36.4) Rapid Testosterone Suppression 346 (34.6) 98 (9.8) Safety Profile 290 (29.0) 95 (9.5) Efficacy Data 255 (25.5) 66 (6.6) Rapid Testosterone Recovery 209 (20.9) 102 (10.2) Tolerability 119 (11.9) 55 (5.5) Co-morbid Disease 76 (7.6) 17 (1.7) Physician Recommended 60 (6.0) 722 (72.3) Other/Unknown 45 (4.5) 22 (2.2)