Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol
Our partnered journal Future Oncology recently published a Clinical Trial Protocol exploring the OPTYX study. This study seeks to generate evidence on the safety and effectiveness of ORGOVYX® (relugolix) for prostate cancer patients in routine care, including treatment course and post-treatment clinical outcomes.
Abstract
OPTYX is a multi-center, prospective, observational study designed to further understand the actual experience of patients with advanced prostate cancer treated with relugolix (ORGOVYX®), an oral androgen deprivation therapy (ADT), by collecting clinical and patient-reported outcomes from routine care settings.
The study aims to enroll 1000 consented patients with advanced prostate cancer from community, academic and government operated clinical practices across the USA. At planned timepoints, real-world data analysis on treatment patterns, adherence and safety as well as health outcomes and health-related quality-of-life (HRQOL) after treatment discontinuation will be published in scientific peer-reviewed journals and presented at relevant conferences.
This study will provide real-world data for practitioners and researchers in their understanding of the safety and effectiveness of relugolix.