Methods: 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).
Results: 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.
Conclusion: 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. opens in new tab; ClinicalTrials.gov number, NCT02044172. opens in new tab.)
Authors: Freddie C. Hamdy, F.R.C.S.(Urol.), F.Med.Sci., Jenny L. Donovan, Ph.D., F.Med.Sci., J. Athene Lane, Ph.D., Chris Metcalfe, Ph.D., Michael Davis, M.Sc., Emma L. Turner, Ph.D., Richard M. Martin, B.M., B.S., Ph.D., Grace J. Young, M.Sc., Eleanor I. Walsh, M.Sc., Richard J. Bryant, Ph.D., F.R.C.S.(Urol.), Prasad Bollina, M.B., B.S., F.R.C.S.(Urol.), Andrew Doble, F.R.C.S.(Urol.), Alan Doherty, F.R.C.S.(Urol.), David Gillatt, F.R.C.S.(Urol.), Vincent Gnanapragasam, Ph.D., F.R.C.S.(Urol.), Owen Hughes, F.R.C.S.(Urol.), D.M., Roger Kockelbergh, D.M., F.R.C.S.(Urol.), Howard Kynaston, M.D., F.R.C.S.(Urol.), Alan Paul, M.D., F.R.C.S.(Urol.), Edgar Paez, F.R.C.S.(Urol.), Philip Powell, M.D., F.R.C.S., Derek J. Rosario, M.D., F.R.C.S.(Urol.), Edward Rowe, M.D., F.R.C.S.(Urol.), Malcolm Mason, M.D., F.R.C.R., James W.F. Catto, Ph.D., F.R.C.S.(Urol.), Tim J. Peters, Ph.D., F.Med.Sci., Jon Oxley, M.D., F.R.C.Path., Naomi J. Williams, Ph.D., John Staffurth, F.R.C.R., F.R.C.P., and David E. Neal, F.Med.Sci. for the ProtecT Study Group*
Source: Hamdy F, Donovan J, Lane A, et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. The New England Journal of Medicine;2023 DOI: 10.1056/NEJMoa2214122
EAU 2023: 15-year Update ProtecT Trial - Part I: Oncology
EAU 2023: 15-year Update ProtecT trial - Part II: Quality of Life
Patient-Reported Outcomes 12 Years after Localized Prostate Cancer
The ProtecT trial: analysis of the patient cohort, baseline risk stratification and disease progression.