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Randomised controlled trial
Similar prostate cancer and all-cause mortality in men with localised prostate cancer undergoing surgery or radiation therapy versus active monitoring at 10 years of follow-up
  1. Philipp Dahm1,2,
  2. Dragan Ilic3,
  3. Timothy Wilt4,5
  1. 1 Urology Section, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA
  2. 2 Department of Urology, University of Minnesota Twin Cities, Minneapolis, Minnesota, USA
  3. 3 Monash University, Melbourne, Victoria, Australia
  4. 4 Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA
  5. 5 Department of Medicine, University of Minnesota Twin Cities, Minneapolis, Minnesota, USA
  1. Correspondence to : Professor Philipp Dahm, Urology Section, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417-2309, USA; pdahm{at}

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Donovan JL, Hamdy FC, Lane JA, et al. Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016;375:1425–37.


Prostate cancer (PCA) remains a common and potentially fatal condition. Effective and safe treatment options are needed. However, few randomised trials have assessed the benefits and harms of radical prostatectomy (RPX), radiation therapy (XRT) and watchful waiting/observation to provide the evidence base for treating men with clinically localised PCA. The Scandinavian Prostate Cancer Group-4 (SPCG-4) trial randomised 695 men diagnosed in the pre-prostate-specific antigen (PSA) era, most had palpable disease, to surgery or observation.1 After a median follow-up of 13.4 years, surgery reduced PCA deaths by 44% (HR=0.56; 95% CI 0.41 to 0.77; absolute risk reduction=11 percentage points). All-cause mortality was reduced by 12.7 percentage points. Reductions were confined to men <65 years of age.

The Prostate Cancer Intervention Versus Observation Trial (PIVOT) randomised 731 men from the early PSA era to RPX or observation.2 After a 10-year median follow-up, surgery did not reduce disease-specific mortality (HR=0.63; 95% CI 0.36 to 1.09). There was also no significant reduction for all-cause mortality. Absolute differences were <3 percentage points for PCA and all-cause mortality. However, there was some evidence suggesting a subgroup effect favouring surgery in men with a PSA >10 ng/mL or intermediate risk disease (p for interaction=0.11 for PCA mortality in both subgroups). The Prostate Testing …

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  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.