title: Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life.
abstract: OBJECTIVE
  To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.
  
  
  METHODS
  A total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures.
  
  
  RESULTS
  A total of 1438 participants completed biopsy questionnaires (88%) and 77-88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms 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 were 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.
  
  
  CONCLUSIONS
  The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.
authors.forename: Athene
authors.initials: A
authors.lastname: Lane
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Metcalfe
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.
authors.forename: Grace J
authors.initials: GJ
authors.lastname: Young
authors.affiliation: School of Clinical Sciences, University of Bristol, Bristol, UK.|Collaboration for Leadership in Applied Health Research and Care West, United Hospitals Bristol, Bristol, UK.
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Peters
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Kerry N L
authors.initials: KN
authors.lastname: Avery
authors.affiliation: Clinical Practice Research Datalink Group, Medicines and Healthcare Products Regulatory Agency, London, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dedman
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Liz
authors.initials: L
authors.lastname: Down
authors.affiliation: School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: Malcolm D
authors.initials: MD
authors.lastname: Mason
authors.affiliation: Nuffield Department of Surgery, University of Oxford, Oxford, UK.
authors.forename: David E
authors.initials: DE
authors.lastname: Neal
authors.affiliation: Nuffield Department of Surgery, University of Oxford, Oxford, UK.
authors.forename: Freddie C
authors.initials: FC
authors.lastname: Hamdy
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Collaboration for Leadership in Applied Health Research and Care West, United Hospitals Bristol, Bristol, UK.
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
mesh_terms: D000368:Aged; D004068:Digestive System Physiological Phenomena; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D011788:Quality of Life; D019529:Sexuality / Q000502:physiology; D016896:Treatment Outcome; D014554:Urination
keywords: ISRCTN 20141297; functional status; prostate cancer; protect trial; quality of life; treatment