Radical prostatectomy did not reduce all-cause or prostate-cancer mortality compared with observation among men with localized prostate cancer after 12 years of follow-up, according to a study published July 19 in the New England Journal of Medicine. The results boost support for observation, and may allow men to avoid unnecessary biopsies and interventions.

The risk of dying from prostate cancer is approximately 3 percent. Observation may provide an appropriate management strategy; yet, it has been infrequently used.

Timothy J. Wilts, MD, from the Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, and colleagues completed a randomized trial to compare radical prostatectomy with observation among men diagnosed with localized prostate cancer. The primary outcome was all-cause mortality, and the secondary outcome was prostate-cancer mortality.

The trial enrolled 731 men (mean age, 67 years) from November 1994 through January 2002 and assigned 364 to radical prostatectomy and 367 to observation. Forty percent of men had low-risk disease, 34 percent fell into the intermediate-risk category and 21 percent were classified as high-risk. Five percent of patients were missing these data.

Among men in the radical prostatectomy cohort, surgery was attempted in 287 men. A total of 311 received definitive therapy—prostatectomy, brachytherapy or radiation therapy. In the observation group, 37 men underwent an attempted radical prostatectomy and 75 received definitive therapy.

Wilts and colleagues reported median survival of 13 years in the radical prostatectomy cohort and 12.4 years in the observation group. At 12 years, 40.9 percent of men in the radical prostatectomy group had died, compared with 43.9 percent in the observation group. The absolute mortality reduction with radical prostatectomy was not significant and dropped over time, from 4.6 percentage points at four years to 2.9 percentage points at 12 years, according to the researchers.

Men in the surgery group reported fewer bone metastases but more morbidity. Bone metastases occurred in 17 men in the radical prostatectomy group and 39 men in the observation group. Perioperative complications during the first 30 days occurred in 21.4 percent of men in the radical prostatectomy group.

The findings suggest the effect of radical prostatectomy on mortality might vary according to prostate-specific antigen (PSA) value and possibly tumor risk.

The subgroup analyses showed that the effect of radical prostatectomy on mortality did not differ significantly by age, Gleason score, race, self-reported performance status or Charlson comorbidity score. However, surgery reduced all-cause mortality by 13.2 percent among men with a PSA score greater than 10 ng per milliliter.      

“Our findings add to evidence supporting observation, and possibly active surveillance, for most men who receive a diagnosis of localized prostate cancer, especially those with a low PSA value or low-risk disease,” wrote Wilts et al.