Search Bar & Filters
Found 1 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating treatments for low and intermediate risk prostate cancer, focusing on erectile dysfunction. This multicenter study compares two radiation therapies: brachytherapy with Iodine 125 and stereotactic body radiotherapy (SBRT). The study aims to analyze the cost and quality of life differences between these treatments over three years, with additional evaluations up to five years including erectile dysfunction, urinary and gastrointestinal side effects, and overall quality of life. Participants are randomly assigned to one of two groups. One group receives brachytherapy delivering a total of 144 Gy to the prostate using Iodine 125. The other group receives SBRT, which delivers 7.25 Gy in five sessions for a total dose of 36.25 Gy, with small markers implanted in the prostate to guide treatment. About 240 patients will be enrolled over two years from approximately twenty centers. During the study, participants will be monitored for erectile dysfunction, treatment side effects, and quality of life for up to five years after treatment. Researchers will perform cost-utility and cost-effectiveness analyses, including measuring quality adjusted life years and erectile dysfunction avoided. Safety and long-term effects will also be assessed to provide comprehensive information for healthcare decision makers.