Phase 1-2 Study Comparing Ultra-Hypofractionated to Moderate-Hypofractionated Radiation Therapy with HDR Brachytherapy Boost for Prostate Cancer

What this Trial Is About

Researchers are evaluating two types of radiation therapy for men with localized prostate adenocarcinoma ultra-hypofractionated UH therapy and moderately hypofractionated MH therapy, combined with image-guided high-dose-rate HDR prostate brachytherapy. The study aims to compare the side effects and tolerability of these radiation approaches and assess if UH therapy is not worse than MH therapy in terms of toxicity. The study also involves outlining MRI-visible dominant intra-prostatic lesions and examining variability between radiation oncologists and radiologists. Secondary goals include monitoring biochemical and clinical failure-free survival at 5 and 10 years. The trial includes two treatment groups one receiving UH radiation therapy delivering 25 Gy in 5 fractions over 7 days, targeting the prostate and the first centimeter of the seminal vesicle the other receiving MH radiation therapy delivering 37.5 Gy in 15 fractions or 36 Gy in 12 fractions over several weeks. All participants receive HDR brachytherapy with a single 15 Gy fraction under anesthesia, involving catheter and marker placement for precise treatment delivery. Imaging such as TRUS, CT scans, and multiparametric MRI are used for planning and monitoring. Treatment techniques include IMRT, VMAT, or SBRT, with dosimetric optimization and live dose monitoring in some patients. Participants undergo regular evaluations including toxicity assessments using CTCAE version 5, urinary symptom scoring IPSS, sexual function questionnaires SHIM, and quality of life surveys EPIC-26 starting before treatment and continuing up to 5 years post-therapy. Clinical outcomes and biochemical failure rates are also tracked at 5 and 10 years. Safety and side effects are monitored carefully at multiple time points, with imaging and laboratory data collected before and after treatment. The study lasts several years to capture both acute and late effects of the therapies.

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.