Abstract: PNFLBA-11
Sources of Funding: Source of Funding:Department of Veterans Affairs, Agency for Healthcare Quality and Research and the National Cancer Institute.

Introduction

We previously found no mortality differences between surgery and observation in men with localized prostate cancer through 12 years. Uncertainty persists regarding nonfatal health outcomes and long-term mortality. We evaluated clinically important outcomes for men with early stage prostate cancer diagnosed during the early PSA era who were randomly assigned to treatment with either surgery or observation._x000D_ _x000D_ _x000D_

Methods

Between 1994 and 2002, we randomly assigned 731 men with localized prostate cancer to radical prostatectomy or observation. We extended follow-up through August 2014 for our primary outcome, all-cause mortality, and main secondary outcome, prostate cancer mortality. We describe disease progression, additional treatments received and patient reported outcomes through the original follow-up of January 2010._x000D_

Results

During 19.5 years of follow-up (Median=12.7 years), 223 of 364 men (61.3%) assigned to surgery died compared to 245 of 367 (66.8%) assigned to observation; (Absolute risk reduction(ARR)=5.5%, 95% Confidence Interval[CI], -1.5, 12.4); Hazard ratio(HR)=0.84, 95%CI, 0.70, 1.01; P=0.06). Prostate cancer mortality occurred in 27 men (7.4%) randomized to surgery versus 42 men (11.4%) randomized to observation; (ARR = 4.0, 95%CI, -0.2 to 8.3; HR=0.63, 95% CI, 0.39 to 1.02; P=0.06). The effect of surgery on mortality did not vary by baseline patient characteristics. Radical prostatectomy may have reduced all-cause mortality among men with intermediate (ARR=14.5%, 95%CI, 2.8 to 25.6) but not low (ARR=0.6%, 95%CI, -10.5 to 11.8) or high risk disease (ARR=2.3%, 95%CI, -11.5 to 16.1)(P for interaction = 0.08). Surgery reduced disease progression treatment, primarily androgen deprivation for asymptomatic, local or PSA progression, by 26.2 percentage points(95%CI, 19.0 to 32.9). Urinary incontinence, erectile and sexual dysfunction were each greater by more than 30 percentage points with surgery. Disease or treatment related bother and limitations in activities of day-to-day living were greater with surgery though 2 years but not at later follow-up. _x000D_ _x000D_

Conclusions

After nearly 20 years, surgery did not significantly reduce all-cause or prostate cancer mortality compared with observation. Surgery had more adverse effects, but reduced disease progression and subsequent treatments; most asymptomatic, local or biochemical and may have reduced all-cause mortality in men with intermediate risk disease. _x000D_

Funding

Source of Funding:Department of Veterans Affairs, Agency for Healthcare Quality and Research and the National Cancer Institute.