Darolutamide with or without Stereotactic Body Radiation Therapy for Castration-Resistant Prostate Cancer with Limited Metastases An International Phase III Randomized Trial Evaluating Combination Therapy

What this Trial Is About

Researchers are investigating treatment options for men with castration-resistant prostate cancer (CRPC) that has spread to a limited number of sites, called oligometastatic CRPC. This form of prostate cancer continues to grow despite hormone therapy to lower male sexual hormones. The trial aims to evaluate whether adding stereotactic body radiotherapy (SBRT), a precise radiation treatment, to darolutamide, a new generation hormone therapy, improves outcomes compared to darolutamide alone. This phase III trial focuses on patients with metastases detected by advanced functional imaging techniques such as PET scans. Participants will be randomly assigned to receive either darolutamide with SBRT or darolutamide alone. Darolutamide is given orally at a dose of 1200 mg per day (two 300 mg tablets twice daily) for up to five years from randomization. SBRT is delivered over one week in three sessions of 10 Gy each, totaling 30 Gy. All patients continue androgen deprivation therapy (ADT) during the study. The study includes a pre-inclusion period for eligibility assessment followed by treatment and monitoring for up to 60 months after randomization. During the study, patients will visit the hospital regularly for medical exams to evaluate their health and treatment tolerance. Researchers will track disease progression and survival using radiographic imaging and other evaluations. The main outcome measured is radiographic progression-free survival from randomization until disease progression or death, for up to five years. The study also includes clinical and biological assessments, tumor evaluations, and safety monitoring throughout the trial period.

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