The results of the 12-year Prostate Cancer Intervention vs Observation Trial (PIVOT) shows men with early-stage prostate cancer who had a radical prostatectomy did no better than those actively monitored without surgery. The results were published yesterday in the New England Journal of Medicine. The absolute differences in all-cause and prostate-cancer mortality were less than 3%.
“Men with early-stage prostate cancer treated with observation had a similar length of life and [similar rates of] prostate cancer deaths with fewer serious harms compared to men treated with surgery,” said Timothy J. Wilt, MD, MPH, of the University of Minnesota School of Medicine and lead author of the trial. “Our results demonstrate that observation is a wise treatment choice for men with early prostate cancer—especially men with prostate-specific antigen (PSA) values of 10 or less.”
The data suggest that men with higher PSA levels may benefit from radical prostatectomies. Those men with a PSA value greater than 10 ng/mL had lower all-cause mortality (P = .04). The data trended toward significance for men with intermediate- or high-risk tumors (P = .07).
The trial included 731 men with localized prostate cancer. The mean age was 67 years, and the median PSA value was 7.8 ng/mL. The patients were randomized to either surgery or observation. The participants were enrolled from 1994 until 2002 and followed every 6 months for at least 8 years, until January 2010. The median follow-up time was 10 years.
The absolute risk reduction of surgery compared to active surveillance was 2.9%. During the follow-up period, 47% of the men (171 of 364) who had undergone a radical prostatectomy died, compared to 49.9% (183 of 367) of the men who were followed by active surveillance (P = .22). Of the men assigned to surgery, 5.8% died from prostate cancer compared to 8.4% of those whose cancer was observed (P = .09), an absolute risk reduction of 2.6%. By the end of the study, 48.4% (354) of the men who participated in the trial had died.
Men assigned to the surgery group had a median survival of 13 years compared to 12.2 years for those undergoing observation. No difference in all-cause mortality and prostate cancer mortality was found with regard to age, race, histologic tumor features, or coexisting conditions.
The PIVOT trial results are in harmony with a study from 2010 that assessed active surveillance or treatment based on PSA screening among men with localized prostate cancer.
One death occurred in the surgery arm, and in the first 30 days following surgery, 21.4% of men had complications. More than 1 month following surgery, over 2% of men had urinary tract infections, surgical repair, bleeding that required transfusion, and urinary catheterization. Urinary incontinence was experienced by 17.3% of men in the radical prostatectomy arm compared to 6.3% of men in the observation group (P < .001). Similarly, erectile dysfunction occurred in 81.1% of those in the surgery group and 44.1% in the observation group (P < .001).
“Our findings support observation for men with localized prostate cancer, especially those who have a low PSA value and those who have low-risk disease,” said Dr. Wilt. “Up to two-thirds of men who have received a diagnosis of prostate cancer have a low PSA value or low-risk disease, but nearly 90% receive early intervention—typically surgery or radiotherapy.”