LAUSR

OBJECTIVE To investigate the functional and quality of life (QoL) outcomes of treatments for localised prostate cancer and inform treatment decision-making. MATERIALS AND METHODS Men aged 50-69 years diagnosed with localised prostate cancer by prostate specific antigen testing and biopsies at 9 UK centres in the ProtecT (Prostate testing for cancer and Treatment) trial were randomised to, or chose one of, three treatments. Of 2565 participants, 1135 men received active monitoring (AM), 750 a radical prostatectomy (RP), 603 external-beam radiotherapy (EBRT) with concurrent androgen-deprivation therapy (ADT) and 77 low-dose-rate brachytherapy (BT, not a randomised treatment). Patient-reported outcomes (PROs) completed annually for 6 years were analysed by initial treatment and censored for subsequent treatments. Mixed effects models were adjusted for baseline characteristics using propensity scores. RESULTS Treatment-received analyses revealed different impacts of treatments over six years. Men remaining on AM experienced gradual declines in sexual and urinary function with age (e.g. increases in erectile dysfunction from 35% of men at baseline to 53% at six years and nocturia similarly 20% to 38%). Radical treatment impacts were immediate and continued over six years. After RP, 95% of men reported erectile dysfunction persisting for 85% at six years, and after EBRT this was reported by 69% and 74% respectively (p<0.001 compared with AM). After RP, 36% of men reported urinary leakage requiring at least 1 pad/day, persisting for 20% at six years, compared with no change in men receiving EBRT or AM (p<0.001). Worse bowel function and bother (e.g. bloody stools 6 % at 6 years and faecal incontinence 10%) was experienced by men after EBRT than after RP or AM (p<0.001) with lesser effects after BT. No treatment affected mental or physical QoL. CONCLUSION Treatment decision-making for localised prostate cancer can be informed by these six-year functional and QoL outcomes.