Evidence from a long term follow-up published in the New England Journal of Medicine suggests that prostatectomy may not improve overall survival compared with observation only among patients diagnosed with low- or high-risk prostate cancer.1
The PIVOT study (ClinicalTrials.gov Identifier: NCT00007644) randomly assigned 731 men with localized prostate cancer to observation or to undergo radical prostatectomy and followed up for approximately 20 years (median, 12.7 years). The primary endpoint of the study was all-cause mortality, and the main secondary outcome was prostate cancer–specific mortality.
By the end of the follow-up, 61% of patients assigned to surgery and 67% to observation had died (absolute difference in risk, 5.5 percentage points; 95% CI, -1.5-12.4; hazard ratio [HR], 0.84; 95% CI, 0.70-1.01; P = .06).
Prostate cancer– or treatment-related mortality was observed in 7.4% of patients assigned to surgery and 11.4% of men assigned to observation (absolute difference in risk, 4.0 percentage points; 95% CI, -0.2-8.3; HR, 0.63; 95% CI, 0.39-1.02; P = 0.06).
Patients who received surgery saw improved all-cause mortality rates in intermediate-risk prostate cancer vs observation, but no benefit was observed in low-risk or high-risk disease. Patients who underwent surgery also needed fewer treatments for disease progression vs observation.
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Patients who received prostatectomy reported higher rates of urinary incontinence and erectile/sexual dysfunction.
The authors concluded that “radical prostatectomy was not associated with significantly lower all-cause or prostate-cancer mortality than observation through 20 years of follow-up among men with localized prostate cancer.”
- Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of prostatectomy versus observation for early prostate cancer. N Engl J Med. 2017 Jul 12. doi: 10.1056/NEJMoa1615869 [Epub ahead of print]