Personalized Radiotherapy with High-Dose Brachytherapy and Androgen Deprivation Therapy for High-Risk Localized Prostate Cancer in Men

What this Trial Is About

Researchers are evaluating a new approach to personalize radiation therapy for men with high-risk localized prostate cancer using multimodal artificial intelligence MMAI. This phase II, single-arm study aims to improve treatment by combining current standard therapies, including high-dose radiation and hormone therapy, while monitoring safety and cancer control outcomes. The study addresses ongoing debates about the best radiation doses and techniques for this patient group and includes research to identify biomarkers predicting treatment success. Participants will receive a combination of treatments a high-dose radiation boost to the prostate via HDR brachytherapy, followed by ultra-hypofractionated whole-pelvis radiation therapy delivered in five fractions. In addition, all patients will undergo two years of androgen deprivation therapy ADT using drugs like Goserelin. The treatment period lasts about three weeks for radiation, with hormone therapy continuing for 24 months. After treatment, patients will be followed for at least five years to monitor outcomes and safety. Throughout the study, participants will undergo regular assessments including toxicity monitoring, quality of life evaluations, and tests of testosterone levels at multiple time points up to five years after radiation. Researchers will also track cancer relapse, metastasis, and survival rates. The study includes frequent visits during treatment and long-term follow-up to fully assess the effects of this personalized therapy approach for high-risk prostate cancer.

Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)