Radical prostatectomy doesn't cut mortality versus observation

Timothy J. Wilt, M.D., M.P.H., from the University of Minnesota School of Medicine in Minneapolis, and colleagues randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median prostate-specific antigen [PSA] value, 7.8 ng/mL) to radical prostatectomy (364 men) or observation (367 men), from November 1994 through January 2002. Patients were followed for a median of 10.0 years, through January 2010.

The researchers found that 47 and 49.9 percent, respectively, of the men in the radical prostatectomy and observation groups died (hazard ratio, 0.88; P = 0.22). Death from prostate cancer or treatment occurred for 5.8 and 8.4 percent assigned to radical prostatectomy and observation, respectively (hazard ratio, 0.63; P = 0.09). Among men with a PSA value greater than 10 ng/mL, radical prostatectomy correlated with decreased all-cause mortality (P = 0.04), and a possible decrease was seen for those with intermediate- or high-risk tumors (P = 0.07). Within 30 days after surgery 21.4 percent of men experienced adverse events, including one death.

"In conclusion, our study showed that, as compared with observation, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality through at least 12 years among men with clinically localized prostate cancer that had been diagnosed in the era of PSA testing," the authors write.

Several authors disclosed financial ties to the pharmaceutical and medical device/technology industries; one author disclosed providing expert testimony for medical malpractice law suits.

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Journal reference: New England Journal of Medicine

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