Testing Bipolar Androgen Therapy with Darolutamide to Delay Metastasis in Men with Non-Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the use of cyclical testosterone and darolutamide in adults with non-metastatic castration-resistant prostate cancer nmCRPC. The study aims to see if this combination can delay the time it takes for the cancer to spread to other parts of the body or lead to death. This research involves patients who have rising prostate-specific antigen PSA levels despite treatment with darolutamide but show no metastatic disease on conventional imaging. Participants will continue to receive androgen deprivation therapy using LHRH agonists or antagonists. They will also receive intramuscular injections of testosterone enanthate on day 1 of each 56-day cycle, with darolutamide taken orally at 600 mg twice daily from days 29 to 56 of each cycle. These treatments will continue until disease progression, unacceptable side effects, death, withdrawal, or study termination. Standard care medications like LHRH agonistsantagonists and darolutamide are provided through usual healthcare channels. Throughout the study, participants will undergo blood tests, scans including whole body bone scans and CT scans, and complete quality of life questionnaires. The main outcome measured is metastasis-free survival, tracked every 8 weeks for approximately four years. Safety and tolerability, PSA response, quality of life, hormone levels, and bone health markers will also be monitored regularly during the study, which may last around two years for some assessments.

Working Out M0 Bipolar Androgen Therapy