Long-term outcome of a moderately hypofractionated, intensity-modulated radiotherapy approach using an endorectal balloon for patients with localized prostate cancer

BACKGROUND: Technical advances in radiotherapy delivery have simultaneously enabled dose escalation and enhanced bladder and rectal sparing. However, the optimal radiation fractionation regimen for localized prostate cancer is unclear. Laboratory and clinical evidence suggest that hypofractionation may improve the therapeutic ratio of radiotherapy. We report our institutional outcomes using moderately hypofractionated, intensity-modulated radiotherapy (IMRT), and an endorectal balloon, with emphasis on long-term biochemical control and treatment-related adverse events in patients with localized prostate cancer. METHODS: Between January 1997 and April 2004, 596 patients with cT1–T3 prostate cancer underwent IMRT using a moderate hypofractionation regimen (76.70 Gy at 2.19 Gy/fraction) with an endorectal balloon. Using D’Amico classification, 226 (37.9%), 264 (44.3%), and 106 (17.8%) patients had low-, intermediate-, or high-risk disease, respectively. The majority of intermediate- and high-risk patients received androgen deprivation therapy. Biochemical relapse-free survival (bRFS) was evaluated using 2005 Phoenix criteria and estimated using the Kaplan–Meier method. RESULTS: The median follow-up was 62 months. Overall 5- and 10-year bRFS rates were 92.7% and 87.7%. For low-, intermediate-, and high-risk patients, the 5-year bRFS rates were 96.9%, 93.3%, and 82.0%, respectively; the 10-year bRFS rates were 91.4%, 89.3%, and 76.2%, respectively. Prostate-specific antigen, Gleason score, and T stage were significant predictors of bRFS (all P < 0.01). The 5-year rates of severe (≥ Grade 3) adverse events were very low: 1.2% for gastrointestinal events and 1.1% for genitourinary events. CONCLUSIONS: Long-term outcomes after moderately hypofractionated IMRT are encouraging. Moderate hypofractionation represents a safe, efficacious, alternative regimen in the treatment of localized prostate cancer.