A phase 1/2 clinical trial has reported positive outcomes for single-fraction stereotactic body radiotherapy (SBRT) in men with localized prostate cancer. This multicenter prospective study examined a 19-Gy dose of prostate SBRT, aiming for effective disease control while ensuring safety and quality of life.
Participants included men with low- to intermediate-risk prostate cancer, with a median age of 72. Out of 45 enrolled, 43 adhered to treatment protocols and were followed for a median of 55.3 months.
The study demonstrated a 92.9% biochemical relapse-free survival (bRFS) rate at three years, surpassing the predefined threshold, indicating favorable efficacy. Adverse events remained low; grade 2 genitourinary (GU) issues were observed in 9.8% of patients, and grade 2 gastrointestinal (GI) events affected 4.9%. Sexual function showed some decline, with erectile dysfunction rising from 21.4% to 38.4% over the three years.
Quality-of-life metrics reflected limited deterioration, suggesting that 19-Gy urethra-sparing SBRT is a feasible option for carefully selected individuals. Nonetheless, researchers stress the need for extended follow-up to assess long-term cancer control. If corroborated by larger trials, single-session SBRT could enhance prostate cancer radiotherapy by minimizing treatment burden while ensuring effective outcomes.