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Commentary on: Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of prostatectomy versus observation for early prostate cancer. N Engl J Med 2017;377:132–42.
Screening, diagnosis and management of localised prostate cancer remains controversial.
Prostate Cancer Intervention Versus Observation Trial (PIVOT) was a randomised controlled trial that accrued 731 men with prostate cancer (PCa) between 1994 and 2002 from Veterans Affairs hospitals. Patients were randomised to radical prostatectomy (n=364) or observation (n=367). Inclusion criteria was clinical stage T1–T2 (organ confined), prostate-specific antigen (PSA) <50 ng/mL, age ≤75 years and estimated life expectancy >10 years. Primary and secondary outcomes were all-cause and prostate-cancer mortality.
Median age was 67 years, median PSA 7.8 ng/mL and 45% of patients were clinical stage T2 (palpable on exam). After 19.5 years follow-up (median 12.7 years), cumulative all-cause mortality was similar between surgery and observation (61.3% vs 66.8%; HR 0.84; 95% CI 0.70 …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.