Comparing Erectile Dysfunction After Brachytherapy Versus Stereotactic Body Radiotherapy in Low and Intermediate Risk Prostate Cancer A Phase III Medico-Economic Study

What this Trial Is About

The TEMPOS-GEniToUrinary Group GETUG study is a multicenter, medico-economic trial comparing two radiation treatmentsbrachytherapy and stereotactic body radiotherapy SBRTin men with low and intermediate risk prostate cancer. The study particularly focuses on erectile dysfunction as a key outcome. Researchers aim to evaluate the cost-utility of SBRT compared to standard Iodine 125 brachytherapy over a period of three years after treatment, including secondary analyses on cost-effectiveness and quality of life up to five years. Participants are assigned to one of two treatment groups. The experimental group receives SBRT delivering 7.25 Gy per fraction, given in five doses for a total of 36.25 Gy to the prostate. Fiducials are implanted in the prostate to help guide treatment using Cyberknife or a conventional linear accelerator with tracking systems. The control group receives brachytherapy with Iodine 125, delivering a total dose of 144 Gy to the prostate. The study includes long-term follow-up to assess erectile dysfunction, genito-urinary and gastro-intestinal toxicities, and quality of life up to five years after treatment. Participants will undergo monitoring and assessments throughout the study period, including evaluations of erectile dysfunction and other side effects. The main outcome measured is the incremental cost-utility ratio comparing SBRT to brachytherapy at three years, with further health economic evaluations at five years. The trial plans to recruit about 240 men across multiple centers over two years, with ongoing data collection on treatment impact, side effects, and quality of life to inform future treatment recommendations and health insurance budgeting.

Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy