Patient-reported outcomes in the ProtecT randomised trial of clinically localised prostate cancer treatments: study design and baseline urinary, bowel and sexual function and quality of life

Objectives
To present the baseline patient-reported outcome measures (PROMs) in the ProtecT (Prostate testing for cancer and Treatment) randomised trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localised prostate cancer and to compare results with other populations.

Materials and methods
1,643 randomised men aged 50-69 years in nine UK cities diagnosed with clinically localised disease identified by prostate-specific antigen (PSA) testing (1999-2009). Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific quality of life impacts (EPIC: 2005 onwards, ICIQ-UI: 2001 onwards, ICSmaleSF), anxiety and depression (HADS), generic mental and physical health (SF-12, EQ-5D-3L) were completed at prostate biopsy clinics before randomisation. Descriptive statistics presented by treatment allocation and by men's age and at biopsy and PSA testing time points for selected measures.

Results
1,438 participants completed biopsy questionnaires (88%) and between 77-88% were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms (LUTS) were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65-70 years), whilst urinary bother and physical health was somewhat worse than in younger men (49-54 years, all p<0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (p<0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments.

Conclusion
ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were comparable to populations screened for prostate cancer and non-cancer controls.