Dr McKay on the Design and Baseline Characteristics of the OPTYX Trial in Prostate Cancer

“The data that were presented at ASCO GU focused on QOL, which was assessed through FACT-P, as well as adherence. Patients completed these questionnaires monthly. We also assessed safety through SAE reporting, treatment discontinuation, and deaths.”

Rana R. McKay, MD, a professor in the Department of Medicine and the Department of Urology at the University of California San Diego School of Medicine, discussed the study design and baseline patient characteristics of the phase 4 OPTYX trial (NCT05467176), a real-world study evaluating relugolix (Orgovyx) use in patients with advanced prostate cancer.

McKay explained that findings from OPTYX that were shared in a poster presentation during the 2026 Genitourinary Cancers Symposium; this presentation focused on patient quality of life, which was assessed through the Functional Assessment of Cancer Therapy–Prostate (FACT-P) scale. FACT-P and treatment adherence questionnaires were completed by patients monthly, she added. Safety was also assessed by the rate of serious adverse effects, treatment discontinuation, and deaths, she noted.

OPTYX enrolled 999 patients, 575 of whom remained on treatment at the March 7, 2025, data cutoff, McKay said. At baseline, 844 patients received relugolix monotherapy, and 155 patients were treated with the agent as a combination component, she explained. Patient baseline characteristics were consistent with real-world populations of patients with advanced prostate cancer, she added. The mean age in the overall population was 70.7 years (SD, 8.4); most patients were White (77.3%) and had localized, locally advanced, or biochemically recurrent disease (70.4%).

Disclosures: McKay holds consulting or advisory roles with Ambrx, Arcus Biosciences, Astellas Medivation, AstraZeneca, AVEO, Bayer, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo, Dendreon, Esiai, Exelixis, Janssen, Lilly, Merck, Myovant Sciences, NeoMorph, Novartis, Pfizer, Precede Bio, Sanofi, Seagen, Sorrento Therapeutics, Sumitomo Pharma Oncology, Telix Pharmaceuticals, Tempus, and Vividion Therapeutics. She also received research funding from Artera (Inst), AstraZeneca (Inst), Bayer (Inst), Bristol Myers Squibb (Inst), Exelixis (Inst), Oncternal Therapeutics (Inst), and Tempus (Inst).