(UroToday.com) The 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between February 13th and 15th 2025, was host to the Poster Session A: Prostate Cancer. Dr. Daniel Spratt presented Abstract 67: Optyx study: Clinical characteristics and preferences for initiating relugolix in a cohort of US patients in real-world care settings.
Relugolix is a luteinizing hormone-releasing hormone (LHRH) antagonist and the only oral androgen deprivation therapy (ADT) approved for advanced prostate cancer, based on the results of the HERO trial.(1) The OPTYX multicenter observational study (NCT05467176), presented by Dr. Spratt, is the first prospective study to evaluate the long-term safety, effectiveness, treatment patterns, disease course, and patient outcomes of relugolix in a real-world setting. As of this presentation, enrollment has been completed.
OPTYX was a multicenter observational study that enrolled men with prostate cancer initiating relugolix across various disease stages and treatment regimens, including monotherapy and combination therapy. Enrollment occurred in diverse clinical settings, including urology, oncology, and radiation oncology clinics. Eligibility required an intent to treat with relugolix for more than four months. Data collected included baseline demographics, clinical characteristics, reasons for initiating treatment, treatment patterns, and quality of life assessments using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. The data collection period spanned from October 2022 to September 2024.
As of September 2024, a total of 999 men had been enrolled and received relugolix, with a median treatment duration of 243.8 days. Baseline characteristics are summarized below. Briefly, the median age was 71 years; 77.4% self-identified as White, and 16.4% as Black.
Median Baseline testosterone levels were 294.0 ng/dL for those without prior ADT, and 14 ng/dL for those with prior ADT.
Moreover, Median PSA baseline levels were 1.6 ng/mL for those with prior ADT and 7.3 ng/mL for those without prior ADT.
Disease state at baseline in patients initiating relugolix included: localized prostate cancer (42%), locally advanced disease (16.6%), biochemical recurrence (11.3%), metastatic castration-sensitive prostate cancer (18.7%), non-metastatic castration-resistant prostate cancer (1.4%), and metastatic castration-resistant prostate cancer (4.8%). Of the 999 men who received relugolix, 52% received it in combination with other prostate cancer therapies, including radiation and systemic treatments.
Among the top reasons for prescribing relugolix, physicians cited:
- Preference for oral over injection administration (41.5%)
- Rapid testosterone suppression (34.6%)
- Safety (29%).
Patients, on the other hand, reported as key factors influencing their decision:
- Physician recommendation (72.2%)
- Preference for oral over injection (36.5%)
- Rapid testosterone recovery (10.2%)
Dr. Spratt concluded his presentation with the following key takeaways:
- The OPTYX study enrolled 999 patients to assess real-world experience with relugolix.
- Over half (52%) of patients started relugolix in combination with other therapies.
- Both patients and physicians preferred the oral formulation, with other top reasons for initiation including safety, rapid testosterone suppression, and rapid testosterone recovery.
Presented by: Daniel Spratt, MD, Radiation Oncologist at University Hospitals Seidman Cancer Center, Beachwood, OH, United States of America
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.
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