Analysis of secondary endpoints:
DM, death, TTP, regional failure, prostate cancer
REGRESSION, TTP, PROSTATE CANCER

Secondary safety endpoints: Between treatment arms differences in each safety endpoints measured as change in domain specific EPIC scores at a specific time points (Secondary efficacy endpoints: For competing-risk endpoints such as PCSM, local failure (LF), regional failure (RF), TTP, and DM, Gray’s cumulative incidence method will be used with death as a competing risk for LF, RF and DM and death not due to prostate cancer for PCSM and TTP. OS and FFBF will be estimated by the Kaplan–Meier method and compared between arms with the log-rank test. Cox regression will be used to obtain hazard ratios (HRs) for OS and TTP. Fine and Gray’s regression will be used for the endpoints with competing risks. Adjusted HRs and the respective 95% confidence interval will be computed. Baseline PSA, stratification variables (baseline EPIC score and ADT status), age, race, and other covariates (Gleason, T-stage), will be adjusted for as appropriate in this analysis.