(ChemotherapyAdvisor) – Radical prostatectomy did not significantly reduce mortality compared with observation in men with localized cancer “detected during the early era of PSA testing,” long-term follow-up of a randomized study concluded in the July 19, 2012 issue of the New England Journal of Medicine.

A total of 731 men with localized prostate cancer diagnosed through PSA screening received either radical prostatectomy or observation between November 1994 and January 2002. Mean age was 67 years and median PSA value, 7.8 ng/mL. All were followed through January 2010, noted lead study author Timothy J. Wilt, MD, MPH, of the Center for Chronic Disease Outcomes, Research, Minneapolis Veterans Affairs (VA) Health Care System, and University of Minnesota School of Medicine, Minneapolis, MN.

Median follow-up was 10.0 years. The primary outcome was all-cause mortality; 47.0% of men (171 of 364) assigned to radical prostatectomy died, as did 49.9% (183 of 367) assigned to observation (HR 0.88; 95% CI 0.71–1.08; P=0.22), for an absolute risk reduction of 2.9 percentage points.

Continue Reading

The secondary outcome was prostate-cancer mortality; 31 men (8.4%) in the observation arm died, compared with 21 (5.8%) of those assigned to the radical prostatectomy arm, who died from prostate cancer or treatment (HR 0.63; 95% CI, 0.36–1.09; P=0.09; absolute risk reduction, 2.6 percentage points).

“The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor,” the investigators reported. Among men with a PSA value >10 ng/mL, radical prostatectomy was associated with reduced all-cause mortality (P=0.04 for interaction) “and possibly among those with intermediate-risk or high-risk tumors (P=0.07 for interaction).”

In the radical prostatectomy arm, 21.4% of men had adverse events within 30 days after surgery, including 1 death.

An accompanying editorial noted that the study was underpowered to detect mortality. “The U.S. demographic characteristics are sobering: an aging population will be at increasing risk for death from prostate cancer. What is a rational approach to control this disease? The most efficient solution will probably include biopsy only for men with lethal cancer, treatment focused on this type of cancer, and individualized treatment approaches,” the editorialists noted.


Clinicaltrials.gov Listing