Dr Dorff on a Real-World Study of Relugolix in Advanced Prostate Cancer

"Although it is a non-interventional registry study, patients are being asked to complete certain questionnaires, which will be important when discussing treatment expectations. Understanding how other patients felt and what their quality of life was like will be very helpful."

Tanya B. Dorff, MD, section chief of the Genitourinary Disease Program and professor in the Department of Medical Oncology and Therapeutics Research at City of Hope, discussed early insights into the clinical characteristics and treatment preferences for initiating relugolix (Orgovyx) in patients with advanced prostate cancer in the ongoing, real-world OPTYX study (NCT05467176).

The OPTYX study is a prospective, non-interventional registry designed to evaluate real-world use of relugolix across a range of United States–based clinical settings, including both urology and medical oncology practices, and in academic and community environments. The goal is to understand how relugolix—the only oral androgen deprivation therapy (ADT) indicated for advanced prostate cancer—is being used in routine practice outside the confines of clinical trials, Dorff explained.

Initial findings from the enrolled popilation (n = 999) suggested that relugolix is most frequently initiated in patients with localized prostate cancer (42.1%), those with locally advanced disease (16.6%), or those with biochemical recurrence (11.3%). However, a notable proportion of patients with metastatic disease are also receiving the agent, particularly in contexts requiring prolonged ADT. Importantly, more than half of the patients enrolled in the registry to date (52.2%) have received relugolix in combination with other systemic therapies, such as androgen receptor pathway inhibitors—highlighting evolving treatment strategies not previously reflected in earlier clinical trials, Dorff noted.

She emphasized that OPTYX will offer important data on how relugolix performs in these combination settings, including insights into treatment-related toxicities and real-world cancer control outcomes. The registry has also incorporated patient-reported outcomes focused on quality of life and testosterone recovery, providing a patient-centered understanding of treatment effects over time.