Adaptive Stereotactic Body Radiotherapy for Intermediate to High-Risk Localized Prostate Cancer with Urinary Symptoms or Enlarged Prostate

What this Trial Is About

Researchers are evaluating the safety, feasibility, and effectiveness of CT or MRI-adaptive stereotactic body radiotherapy SBRT given in five weekly treatments for patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms or enlarged prostate prostatic hyperplasia. This phase II international multicenter study focuses on patients with intermediate to very high-risk localized prostate cancer, especially those with prostate volume over 60 mL or an International Prostate Symptom Score IPSS greater than 12. SBRT offers the benefit of shorter treatment durations compared to conventional radiotherapy but may not suit all patients with certain urinary symptoms or prostate enlargement. The study involves delivering definitive CT or MRI online adaptive SBRT to the prostate and nearby areas in five weekly fractions. The total radiation dose follows protocols similar to the PACE trial, with specific doses to the prostate, seminal vesicle, and planning target volumes based on risk classification. Patients receive this treatment under standard care conditions tailored to their prostate cancer risk and urinary symptoms. The study includes two cohorts a pilot study and a validation cohort, each designed to evaluate urogenital toxicity within three months after treatment and treatment discontinuation rates. Participants will be monitored for acute urogenital toxicity grade 3 or higher within three months after finishing radiotherapy, as well as for gastrointestinal toxicity, mortality, biochemical progression, hormonal therapy-free survival, overall survival, and quality of life for up to five years after treatment. Optional assessments include uroflowmetry before treatment. The research team will collect questionnaires and monitor long-term urinary and gastrointestinal side effects to evaluate safety and effectiveness. The total study duration extends up to 2031, with primary outcome assessments completed by 2026.

Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer