In a previous study, researchers found no significant differences in all-cause or prostate cancer mortality rates between men with localized prostate cancer who had a radical prostatectomy and those treated with observation only. This research was based on 12 years of follow-up. In this current study, the researchers build on their previous work, providing mortality data through nearly 20 years of follow-up and focusing on disease progression, treatment, and patient-reported outcomes.
From November 1994 through January 2002, 731 men with localized prostate cancer (mean age, 67 years; median prostate-specific antigen [PSA] level, 7.8 ng/mL) were randomly assigned to radical prostatectomy or observation. To be included in the study, men had to have a PSA level of less than 50 ng/mL, be age 75 or younger, have negative bone scan results for metastatic disease, and have a life expectancy of 10 years or more. All-cause and prostate cancer mortality was assessed until August 2014, for a minimum of 12 years and a maximum of 19.5 years, or until the patient died.
At nearly 20 years of follow-up, the cumulative incidence of all-cause mortality wasn't significantly different between men assigned to the surgery (61.3%) and the observation (66.8%) treatment groups; the absolute difference in risk between groups was 5.5 percentage points. Similarly, the cumulative incidence of prostate cancer mortality (death attributed to prostate cancer or treatment) also wasn't significantly different between the surgery and observation groups (7.4% and 11.4%, respectively), for an absolute difference in risk between groups of four percentage points.
Compared with observation, surgery may have been associated with lower all-cause mortality rates in men who had intermediate-risk disease or a PSA value of more than 10 ng/mL. However, in men who had low- or high-risk disease or a PSA value of 10 ng/mL or less, surgery was not associated with lower all-cause mortality compared with observation. Fewer men who had surgery experienced disease progression or received additional treatment than men in the observation group. However, urinary incontinence, erectile and sexual dysfunction, and adverse effects on physical function and activities of daily living occurred less frequently in the observation group.-KR
REFERENCE