The OPTYX study has unveiled compelling real-world evidence supporting the use of oral androgen deprivation therapy (ADT) relugolix (Orgovyx) in advanced prostate cancer treatment, with both physicians and patients showing strong preference for oral administration over traditional injectable options.
Patient and Physician Preferences
The comprehensive study, involving 999 patients, revealed that 52.2% received relugolix in combination with other prostate cancer therapies. Notably, 41.5% of physicians and 36.4% of patients specifically chose relugolix over injectable alternatives. Key factors influencing treatment selection included rapid testosterone suppression (34.6% physician, 9.8% patient), safety profile (29.0% physician, 9.5% patient), and the potential for rapid testosterone recovery (21.0% physician, 10.2% patient).
"OPTYX is the first prospective study to collect long-term, real-world data on relugolix for advanced prostate cancer," stated Dr. Daniel E. Spratt, chairman and professor at University Hospitals Seidman Cancer Center. "This study aims to provide evidence on safety, effectiveness, treatment patterns, disease course, and patient outcomes."
Clinical Characteristics and Treatment Patterns
The study population demonstrated diverse disease states, with patients presenting local, locally advanced, and metastatic disease. Among evaluable patients, those receiving relugolix monotherapy (n=477) or combination therapy (n=522) showed distinct characteristics:
- Mean age: 71.7 years for monotherapy vs 69.9 years for combination therapy
- Predominantly White population (73.8% monotherapy, 80.5% combination)
- Majority without distant metastasis at enrollment (62.9% monotherapy, 64.8% combination)
- Varied Gleason scores, with significant proportions in the 7-10 range
Treatment Outcomes and Monitoring
Baseline measurements revealed a median testosterone concentration of 271.5 ng/dL, with 19.3% of patients showing levels below 50 ng/dL. The median PSA concentration at baseline was 7.1 ng/mL. Dr. Spratt emphasized the importance of considering patient history when initiating relugolix treatment, noting significant differences in baseline testosterone and PSA levels between ADT-naive patients and those with prior ADT exposure.
The study reported a median treatment duration of 243.8 days, with a 28.2% discontinuation rate between October 2022 and September 2024. Treatment completion (15.9%) and adverse events (5.0%) were the primary reasons for discontinuation.
Future Implications
The OPTYX study continues to collect data, with patients being followed for up to 5 years. This ongoing research promises to provide valuable insights into the long-term effectiveness and real-world application of relugolix in advanced prostate cancer treatment. As Dr. Spratt concluded, "As more data is collected, the results will help inform clinical decision making for prostate cancer patients."
