Radical Prostatectomy May Not Reduce Mortality in Most Men with Localized Prostate Cancer Compared to Watchful Waiting

DynaMed Weekly Update - Volume 7, Issue 31

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Prostate cancer is the most common cancer in men (not counting skin cancer) and the second most common cause of cancer deaths in men, but many aspects of the management of this disease are controversial. PSA screening has become common over the last 2 decades, and has contributed to increased detection rates of early stage low-risk disease (of note, the United States Preventive Services Task Force [USPSTF] recently issued a statement recommending against routine prostate-specific antigen [PSA] screening for all men, regardless of age [Ann Intern Med 2012 May 21 early online] [DynaMed Weekly Update Vol 7, issue 22]) The best treatment for men with low-risk prostate cancer remains unclear. At the extremes are radical prostatectomy and watchful waiting, but comparative efficacy studies have been inconclusive to date (Cochrane Database Syst Rev 2010 Nov 10;(11):CD006590).

The PIVOT trial compared radical prostatectomy to watchful waiting in 731 men with localized prostate cancer detected by PSA testing. Men ≤ 75 years old (mean age 67 years) were randomized to radical prostatectomy vs. watchful waiting from 1994 to 2002 and were followed for up to 15 years (median follow-up 10 years). At baseline, all men had PSA < 50 ng/mL and life expectancy of ≥ 10 years.

During the trial, 77.2% of the radical prostatectomy group and 79.6% of the watchful waiting group received their allocated treatment. There was no significant difference in all-cause mortality between the 2 groups (47% vs.49.9%) (level 2 [mid-level] evidence) in the overall intention-to-treat analysis, but prostatectomy was associated with a trend toward reduced prostate cancer-related mortality (5.8% vs. 8.4%, p = 0.09). In a subgroup analysis of 251 men with PSA > 10 ng/mL at baseline, however, prostatectomy was associated with significant reductions in both all-cause mortality (48.4% vs. 61.6%, p < 0.05, NNT 8) and prostate cancer-related mortality (5.6% vs. 12.8%, p < 0.05, NNT 14) (N Engl J Med 2012 Jul 19;367(3):203).

For more information, see the Prostate cancer topic in DynaMed.


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