Phase III Study of Darolutamide with or without Stereotactic Body Radiation Therapy for Men with Castration-Resistant Prostate Cancer and Limited Metastases Detected by Advanced Imaging

What this Trial Is About

Researchers are investigating treatments for castration-resistant prostate cancer CRPC that has spread to a limited number of sites, called oligometastatic CRPC. This trial compares the effectiveness of combining stereotactic body radiation therapy SBRT with the hormone therapy drug darolutamide against darolutamide alone. The study aims to see if this combination can better control cancer growth in men whose cancer continues despite hormone therapy and is detected using advanced PET scans. Participants will be randomly assigned to one of two groups one receiving darolutamide plus SBRT, and the other receiving darolutamide alone. Both groups will continue with androgen deprivation therapy ADT throughout the study. Darolutamide is taken orally twice daily for up to five years, while SBRT is given as a precise radiation treatment over one week. The study is international, open-label, and will last up to 60 months, including treatment and follow-up. During the trial, participants will have regular hospital visits for medical exams and tests to monitor their health and treatment effects. These include tumor assessments, blood tests, and questionnaires about pain and quality of life. The main outcome measured is radiographic progression-free survival, tracking the time until cancer progression or death. Secondary measures include overall survival, treatment safety, biochemical response, and quality of life assessments over the five-year period.

Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging