Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

Between 1999 and 2009 in the United Kingdom, 82,429 men between 50 and 69 years of age received a prostate-specific antigen (PSA) test. Localized prostate cancer was diagnosed in 2664 men. Of these men, 1643 were enrolled in a trial to evaluate the effectiveness of treatments, with 545 randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy.

At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes).

Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P = 0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis.

After 15 years of follow-up, prostate cancer-specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer. (Funded by the National Institute for Health and Care Research; ProtecT Current Controlled Trials number, ISRCTN20141297; number, NCT02044172.).

The New England journal of medicine. 2023 Mar 11 [Epub ahead of print]

Freddie C Hamdy, Jenny L Donovan, J Athene Lane, Chris Metcalfe, Michael Davis, Emma L Turner, Richard M Martin, Grace J Young, Eleanor I Walsh, Richard J Bryant, Prasad Bollina, Andrew Doble, Alan Doherty, David Gillatt, Vincent Gnanapragasam, Owen Hughes, Roger Kockelbergh, Howard Kynaston, Alan Paul, Edgar Paez, Philip Powell, Derek J Rosario, Edward Rowe, Malcolm Mason, James W F Catto, Tim J Peters, Jon Oxley, Naomi J Williams, John Staffurth, David E Neal, ProtecT Study Group

From the Nuffield Department of Surgical Sciences, University of Oxford, Oxford (F.C.H., R.J.B., D.E.N.), Population Health Sciences (J.L.D., J.A.L., C.M., M.D., E.L.T., R.M.M., G.J.Y., E.I.W., T.J.P., N.J.W.) and Bristol Trials Centre (J.A.L., C.M., G.J.Y.), Bristol Medical School, University of Bristol, the Department of Urology, Southmead Hospital and Bristol Urological Institute (E.R.), and the Department of Cellular Pathology, North Bristol NHS Trust (J.O.), Bristol, the Department of Urology and Surgery, Western General Hospital, University of Edinburgh, Edinburgh (P.B.), the Department of Urology (A. Doble) and the Division of Urology, Department of Surgery and Cambridge Urology Translational Research and Clinical Trials Office, Cambridge Biomedical Campus (V.G., D.E.N.), Addenbrooke's Hospital, Cambridge, the Department of Urology, Queen Elizabeth Hospital, Birmingham (A. Doherty), the Department of Urology, Cardiff and Vale University Health Board (O.H., H.K.), and the School of Medicine (M.M.) and the Division of Cancer and Genetics (J.S.), Cardiff University, Cardiff, the Department of Urology, University Hospitals of Leicester, Leicester (R.K.), the Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds (A.P.), the Department of Urology, Freeman Hospital, Newcastle-upon-Tyne (E.P., P.P.), and the Department of Urology, Royal Hallamshire Hospital (D.J.R., J.W.F.C.), and the Academic Urology Unit, Medical School, University of Sheffield (J.W.F.C.), Sheffield - all in the United Kingdom; and the Department of Urological Oncology and Robotic Surgery, Macquarie University, Sydney (D.G.).