Phase II Study of Relugolix With Androgen Receptor Pathway Inhibitors for Men With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Levels

What this Trial Is About

Researchers are evaluating intermittent relugolix combined with an androgen receptor pathway inhibitor ARPI in men with metastatic hormone-sensitive prostate cancer who have achieved an optimal PSA response. The study aims to compare continuous treatment versus intermittent treatment approaches to understand their effects on fatigue, progression-free survival, and other health outcomes. This is a Phase II randomized trial led by the University of Utah focusing on treatment de-escalation based on PSA levels. Participants initially receive continuous treatment with relugolix plus an ARPI for 6 to 12 months. Those whose PSA levels drop to 0.2 ngmL or below may be randomized into one of two groups one continuing standard continuous treatment with relugolix or androgen deprivation therapy plus ARPI, and the other receiving intermittent treatment with relugolix plus ARPI. Another cohort includes participants already achieving low PSA levels who receive intermittent treatment. During the study, participants will be closely monitored with assessments including fatigue scores at 6 months, progression-free survival at 12 months, and quality of life measurements up to 13 months. Other evaluations include sexual function, hot flash severity, cognitive function, testosterone recovery, and overall survival tracked for up to 3 years. Participants use smartphones to access study applications, and their health status and treatment effects are regularly evaluated throughout the trial duration.

Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer