For men with localized prostate cancer detected by prostate-specific antigen (PSA) level, treatment with radical prostatectomy did not significantly reduce mortality compared with observation, according to overall results of the large, randomized, controlled PIVOT trial (Wilt TJ, et al. N Engl J Med. 2012; 367:203-213). All-cause mortality and prostate-specific mortality were similar for the surgery and observation groups over a 12-year follow-up. Results suggest that surgery may be a better option than observation for men with intermediate- and high-risk localized prostate cancer, but low-risk localized prostate cancer can be safely managed with observation.
Overall, absolute differences in mortality favoring surgery were less than 3 percentage points, explained lead author Timothy J. Wilt, MD, Minneapolis Veterans Affairs Health Care System, Minnesota. “Surgery might reduce mortality for men with higher PSA values and possibly among men with higher-risk tumors, but not among men with PSA levels of ≤10 ng/mL or low-risk tumors,” Wilt wrote.
He noted that PIVOT was conducted in the early era of PSA testing, and that in the current era men suspected of having prostate cancer undergo repeated PSA testing and sometimes repeat biopsies, which detect more indolent cancers. These factors increase the likelihood of overdiagnosis and overtreatment. “Our findings support observation for men with localized prostate cancer, especially those who have low-risk disease,” he wrote.
PIVOT randomized 364 men to radical prostatectomy and 367 to observation alone. All participants were suspected of having prostate cancer based on PSA testing and had histologically confirmed localized prostate cancer diagnosed within the previous year. Mean age was 67 years, about one-third were black, and median PSA value was 7.8 ng/mL. About 40% of the men had low-risk prostate cancer, 34% intermediate-risk prostate cancer, and 21% high-risk prostate cancer.
At a median follow-up of 10 years, mortality was 47% in the surgery group versus 49.9% in the observation group, an absolute reduction of 2.9% for surgery. The rates of prostate-specific mortality were 5.8% for surgery versus 8.4% for observation, an absolute risk reduction of 2.6%. The effect of treatment on all-cause mortality was similar according to age, race, coexisting illness, performance status, or histologic tumor features.
Radical prostatectomy was associated with reduced all-cause mortality among men with PSA >10 ng/mL and for men with intermediate- or high-risk tumors.
Perioperative adverse events (occurring within 30 days of surgery) were reported in 21.4% of men. Rates of urinary incontinence and erectile dysfunction were significantly higher in the radical prostatectomy group (P <.001 for both comparisons vs observation).