Patient-Reported Outcomes 12 Years after Localized Prostate Cancer

Background: Long-term patient-reported outcomes are needed to inform treatment decisions for localized prostate cancer.

Methods: Patient-reported outcomes of 1643 randomly assigned participants in the ProtecT (Prostate Testing for Cancer and Treatment) trial were evaluated to assess the functional and quality-of-life impacts of prostatectomy, radiotherapy with neoadjuvant androgen deprivation, and active monitoring. This article focuses on the outcomes of the randomly assigned participants from 7 to 12 years using mixed effects linear and logistic models.

Results: Response rates exceeded 80% for most measures. Among the randomized groups over 7 to 12 years, generic quality-of-life scores were similar. Among those in the prostatectomy group, urinary leakage requiring pads occurred in 18 to 24% of patients over 7 to 12 years, compared with 9 to 11% in the active monitoring group and 3 to 8% in the radiotherapy group. In the prostatectomy group, 18% reported erections sufficient for intercourse at 7 years, compared with 30% in the active monitoring and 27% in the radiotherapy groups; all converged to low levels of potency by year 12. Nocturia (voiding at least twice per night) occurred in 34% in the prostatectomy group compared with 48% in the radiotherapy group and 47% in the active monitoring group at 12 years. Fecal leakage affected 12% in the radiotherapy group compared with 6% in the other groups by year 12. The active monitoring group experienced gradual age-related declines in sexual and urinary function, avoiding radical treatment effects unless they changed management.

Conclusion: ProtecT provides robust evidence about the continued impacts of treatments in the long term. These data allow patients newly diagnosed with localized prostate cancer and their clinicians to assess the trade-offs between treatment harms and benefits and enable better informed and prudent treatment decisions. (Funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme projects 96/20/06 and 96/20/99; ISRCTN number, ISRCTN20141297; number, NCT02044172.)

Jenny L. Donovan, Ph.D., F.Med.Sci.1, Freddie C. Hamdy, F.R.C.S. (Urol.), F.Med.Sci.2, J. Athene Lane, Ph.D.1,3, Grace J. Young, M.Sc.1,3, Chris Metcalfe, Ph.D.1,3, Eleanor I. Walsh, M.Sc.1, Michael Davis, M.Sc.1, Thomas Steuart-Feilding, B.A.1, Jane M. Blazeby, F.R.C.S. (Gen. Surg.), F.Med.Sci.1, Kerry N. L. Avery, Ph.D.1, Richard M. Martin, B.M.B.S., Ph.D.1, Prasad Bollina, M.B.B.S., F.R.C.S. (Urol.)4, Andrew Doble, M.S., F.R.C.S. (Urol.)5, Alan Doherty, F.R.C.S. (Urol.)6, David Gillatt, M.S., F.R.C.S. (Urol.)7, Vincent Gnanapragasam, Ph.D., F.R.C.S. (Urol.)8, Owen Hughes9, Roger Kockelbergh, D.M., F.R.C.S. (Urol.)10, Howard Kynaston, M.D., F.R.C.S. (Urol.)9, Alan Paul, M.D., F.R.C.S. (Urol.)11, Edgar Paez, F.R.C.S. (Urol.)12, Phillip Powell, M.D., F.R.C.S.12, Derek J. Rosario, M.D., F.R.C.S. (Urol.)13, Edward Rowe, M.D., F.R.C.S. (Urol.)14, Malcolm Mason, M.D., F.R.C.R.15, James W. F. Catto, Ph.D., F.R.C.S. (Urol.)13,16, Tim J. Peters, Ph.D., F.Med.Sci.1, Julia Wade, Ph.D.1, Emma L. Turner, Ph.D.1, Naomi J. Williams, Ph.D.1, Jon Oxley, M.D., F.R.C.Path.17, John Staffurth, F.R.C.R., F.R.C.P.18, Richard J. Bryant, Ph.D., F.R.C.S. (Urol.)2, and David E. Neal, C.B.E., F.Med.Sci.2,8for the ProtecT study group*

  1. Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom
  2. Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom
  3. Bristol Trials Centre, Bristol Medical School, University of Bristol, United Kingdom
  4. Department of Urology and Surgery, Western General Hospital, University of Edinburgh, United Kingdom
  5. Department of Urology, Addenbrooke’s Hospital, Cambridge, United Kingdom
  6. Department of Urology, Queen Elizabeth Hospital, Birmingham, United Kingdom
  7. Department of Urological Oncology and Robotic Surgery, Macquarie University, Sydney
  8. Division of Urology, Department of Surgery and Cambridge Urology Translational Research and Clinical Trials Office, Cambridge, United Kingdom
  9. Department of Urology, Cardiff and Vale University Health Board, Cardiff, United Kingdom
  10. Department of Urology, University Hospitals of Leicester, Leicester, United Kingdom
  11. Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
  12. Department of Urology, Freeman Hospital, Newcastle upon Tyne, United Kingdom
  13. Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom
  14. Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, United Kingdom
  15. School of Medicine, Cardiff University, Cardiff, United Kingdom
  16. Academic Urology Unit, Medical School, University of Sheffield, Sheffield, United Kingdom
  17. Department of Cellular Pathology, North Bristol NHS Trust, Bristol, United Kingdom
  18. Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, United Kingdom
Source: Donovan JL., Hamdy FC., Lane JA. et al. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment. New England Journal of Medicine Evidence. 2023. DOI: 

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