Study Comparing Safety of Two Types of Post-prostatectomy Radiotherapy for Localized Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety outcomes of two types of post-prostatectomy radiotherapy for patients with localized prostate cancer. The study compares Hypofractionated postprostatectomy radiotherapy HYPORT with Conventionally fractionated postprostatectomy radiotherapy COPORT to determine which approach may work better. This clinical trial is prospective, open-label, and randomized, aiming to address the optimal radiation dose per fraction for this condition. Participants are randomly assigned to one of two groups. One group receives COPORT, which consists of 66-74 Gy delivered in 33-37 daily fractions of 2 Gy over 7 weeks. The other group receives HYPORT, which involves 57.5-65 Gy in 23-26 daily fractions of 2.5 Gy over 5 weeks. Both radiation therapies are given to the prostate bed without disease progression or unacceptable toxicity. After treatment, patients are followed monthly for 3 months, then every 3 months, for a total of 5 years. During the study, participants will undergo assessments of toxicities, quality of life, progression-free survival, overall survival, and prostate cancer-specific survival. Researchers will track physical activity and medical expenses related to treatment. Safety monitoring focuses on gastrointestinal and urogenital adverse events over 5 years. This long-term follow-up helps evaluate both safety and treatment outcomes to guide future care for localized prostate cancer.

Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer