Phase II Trial of Neoadjuvant Enzalutamide and Relacorilant Plus Hormone Therapy Versus Placebo for Men With High-risk Localized Prostate Cancer

What this Trial Is About

Researchers are studying the safety and effectiveness of combining two drugs, relacorilant and enzalutamide, with hormone therapy androgen deprivation therapy in men with advanced, high-risk prostate cancer that has not responded to standard treatments. The goal is to see if this combination is safe and if it can improve surgery outcomes and delay cancer spread. This is a randomized, phase II trial sponsored by the University of Chicago. Participants receive either relacorilant plus enzalutamide with hormone therapy or a placebo plus enzalutamide with hormone therapy before surgery. All participants have androgen deprivation therapy injections every 1 to 3 months before undergoing a radical prostatectomy, which is surgery to remove the prostate and surrounding tissue. Surgery occurs up to 4 weeks after the pre-surgery treatments. The study compares these two groups to evaluate the added effect of relacorilant. During the approximately 3 years and 9 months of participation, participants will be monitored for response to treatment at 24 weeks and followed for up to nearly 4 years to check cancer recurrence and spread. Assessments include imaging scans, blood tests, and evaluations of biochemical and radiographic responses. Safety and effectiveness are carefully tracked throughout the study period.

A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer