Personalized Prostate-only Radiotherapy with Shortened Androgen Deprivation for High-risk Localized Prostate Cancer Using AI Classification

What this Trial Is About

Researchers are evaluating a new personalized treatment approach for men with high-risk localized prostate cancer using artificial intelligence classification. This prospective, single-arm phase II trial aims to individualize the duration of radiotherapy and androgen deprivation therapy ADT based on patient risk. The study focuses on improving treatment efficiency by shortening ADT duration while maintaining disease control compared to current guidelines. Participants will receive a combination of treatments including a high-dose-rate HDR brachytherapy boost to the prostate, followed by stereotactic body radiation therapy SBRT consisting of five daily fractions. Additionally, all patients will undergo twelve months of androgen deprivation therapy given concurrently and as adjuvant treatment. The treatment schedule includes one HDR brachytherapy fraction with fiducial placement, a 14-day gap, and then five consecutive days of SBRT. During the study, participants will be closely monitored through multiple assessments including disease-free survival measured five years after treatment, local and metastatic progression, overall and prostate cancer-specific survival, biochemical failure, and quality of life evaluations. Toxicity related to genitourinary and gastrointestinal systems will be tracked during and after radiotherapy. Testosterone recovery and other safety parameters will be assessed periodically up to five years. The total follow-up period extends to five years after treatment completion.

Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)