A multi-center phase 2 study enrolled seventy-three patients between September 2004 and June 2006. After insertion of fiducial gold markers, they were treated with image-guidance (IGRT) using conformal techniques with intensity-modulation, if necessary, and then followed every 6 months for toxicity rating and PSA. Patient reported outcomes were collected yearly. Median follow up was 4.6 years.
At 4 years post-radiotherapy, the cumulative incidence of combined urinary and bowel grade 3 toxicity was 7%(95%CI 3-16%) and grade 2+ was 33%(95%CI 24-46%). All except two patients recovered from their grade 3 events. Patient-reported reduction of function was most pronounced at year two for urinary function (mean 鈭?, SD 16), and at year one for bowel function (mean 鈭?, SD 21). The cumulative incidence of biochemical (PSA nadir + 2) or biopsy-proven relapse at 4 years was 9%(95%CI 4-18%).
Hypofractionated radiotherapy is clinically feasible and more convenient than conventional schedules for patients with localized prostate cancer. Phase 3 multicenter studies are on-going ().