Treatment schema and statistical analysis
toxicity, prostate module, occurring>90, prostate, Cancer
PROSTATE, CANCER
The radiation dose to the whole prostate was 36.25 Gy in 5 fractions of 7.25 Gy. For the Phase I part of the study, dose escalation to the DIN was performed using the traditional 3 + 3 design.A Simon optimal two-stage designClick here for additional data file.Secondary endpoints were late toxicity (occurring>90 days from first fraction), PSA kinetics, and patient-reported outcome. European Organization for Research and Treatment of Cancer QoL Form PR25 (prostate module) together with the IPSS score were collected at baseline and 1, 3, and 6, months after treatment. After 6 months QofL evaluation was not mandated by the trial but collected whenever possible. Health-related QoL outcomes were scored using the European Organization for Research and Treatment of Cancer guidelines