Background Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. Methods We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. Results The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. Conclusions In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).
The New England journal of medicine. 2016 Sep 14 [Epub ahead of print]
Jenny L Donovan, Freddie C Hamdy, J Athene Lane, Malcolm Mason, Chris Metcalfe, Eleanor Walsh, Jane M Blazeby, Tim J Peters, Peter Holding, Susan Bonnington, Teresa Lennon, Lynne Bradshaw, Deborah Cooper, Phillipa Herbert, Joanne Howson, Amanda Jones, Norma Lyons, Elizabeth Salter, Pauline Thompson, Sarah Tidball, Jan Blaikie, Catherine Gray, Prasad Bollina, James Catto, Andrew Doble, Alan Doherty, David Gillatt, Roger Kockelbergh, Howard Kynaston, Alan Paul, Philip Powell, Stephen Prescott, Derek J Rosario, Edward Rowe, Michael Davis, Emma L Turner, Richard M Martin, David E Neal, ProtecT Study Group
From the School of Social and Community Medicine (J.L.D., J.A.L., C.M., E.W., J.M.B., M.D., E.L.T., R.M.M.), Bristol Randomised Trials Collaboration (J.A.L., C.M.), and the School of Clinical Sciences (T.J.P.), University of Bristol, National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust (J.L.D.), and Bristol Urological Institute, North Bristol NHS Trust (L.B., E.S., D.G., E.R.), Bristol, Nuffield Department of Surgical Sciences, University of Oxford, Oxford (F.C.H., P. Holding, D.E.N.), the School of Medicine, University of Cardiff (M.M.), and the Department of Urology, Cardiff and Vale University Health Board (A.J., S.T., H.K.), Cardiff, the Department of Urology, University Hospitals Leicester, Leicester (S.B., R.K.), the Department of Urology, Freeman Hospital, Newcastle-upon-Tyne (T.L., P.P.), the Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds (D.C., C.G., A.P., S.P.), the Department of Urology, Addenbrooke's Hospital (P. Herbert, A. Doble), and the Academic Urology Group, University of Cambridge (D.E.N.), Cambridge, the Academic Urology Unit, University of Sheffield, Sheffield (J.H., J.C., D.J.R.), the Department of Urology and Surgery, Western General Hospital, Edinburgh (N.L., J.B., P.B.), and the Department of Urology, Queen Elizabeth Hospital, Birmingham (P.T., A. Doherty) - all in the United Kingdom.