Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol.
Daniel E SprattTanya Barauskas DorffRana R McKayBenjamin H LowentrittMark FallickSergio C GatoulisScott C FlandersAshley E RossPublished in: Future oncology (London, England) (2024)
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. Clinical Trial Registration: NCT05467176 (ClinicalTrials.gov).
Keyphrases
- prostate cancer
- healthcare
- data analysis
- clinical trial
- radical prostatectomy
- study protocol
- randomized controlled trial
- patient reported
- primary care
- palliative care
- quality improvement
- mental health
- stem cells
- systematic review
- type diabetes
- open label
- adipose tissue
- insulin resistance
- combination therapy
- replacement therapy
- double blind
- bone marrow
- general practice