Abstract: PD09-03
Sources of Funding: Funding for the study was provided by Agency for Healthcare Research and Quality (1R01HS019356, 1R01HS022640); Patient-Centered Outcomes Research Institute (CE-12-11-4667); Vanderbilt Institute of Clinical and Translational Research (UL1TR000011 from NCATS/NIH); NIH/NCI Grant 5T32CA106183 (MDT). Each of these provided financial support through grants, but none was involved in the conduct of the study.

Introduction

Prostate cancer (PCa) treatments are associated with urinary, sexual, and bowel side effects. Previous comparative effectiveness studies are limited by narrow inclusion criteria and outmoded treatments. Herein, we present 3-year functional outcomes in a diverse population of patients receiving contemporary treatment for localized PCa. _x000D_ _x000D_

Methods

The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, cohort study of men diagnosed with localized PCa in 2011-2012. Men 80 years old or younger, with newly diagnosed cT1 or cT2 PCa, prostate specific antigen less than 50 ng/dL, were accrued from five Surveillance Epidemiology, and End Results (SEER) registry sites and from the Cancer of the Prostate Strategic Urologic Research Endeavor. Patient-reported urinary, sexual and bowel function, using the 26-item Expanded Prostate Index Composite (EPIC) at baseline, 6, 12, and 36 months after enrollment (range 0-100, higher score indicates better function). _x000D_ _x000D_

Results

The analytic cohort contained 2,543 men: 26% non-white; 45% low-risk, 39% intermediate risk, 16% high risk. 1,523 (59.9%) men underwent radical prostatectomy (RP), 599 (23.6%) external beam radiotherapy (EBRT), and 421 (16.6%) active surveillance (AS). At 3 years, sexual function after RP was significantly worse than EBRT (-17.1 points; 95% CI: -21.7 to -12.6; p<0.001), Figure. Differences in sexual function between EBRT and AS at 3 years, while statistically significant, were not clinically significant (-5.9 points; 95% CI -11.0 to -0.8; p=0.023). RP was associated worse urinary continence scores than EBRT (-18 points; 95%CI: -20.6, -15.5; p<0.001) or AS (-13.4 points; 95% CI: -16.8, -10.1; p<0.001). At 3 years, 14% of RP men reported moderate or big problem with urinary leakage compared to 5% for EBRT and 6% for AS (p<0.001). Functional outcomes were driven largely by baseline function and treatment (Figure). There were no clinically significant differences in bowel or hormone function and no difference in survival. _x000D_ _x000D_

Conclusions

The effects of modern treatments are similar to the effects of older modalities noted in prior studies. This information will provide a foundation for shared decision making, rooted in contemporary population-based data._x000D_ _x000D_

Funding

Funding for the study was provided by Agency for Healthcare Research and Quality (1R01HS019356, 1R01HS022640); Patient-Centered Outcomes Research Institute (CE-12-11-4667); Vanderbilt Institute of Clinical and Translational Research (UL1TR000011 from NCATS/NIH); NIH/NCI Grant 5T32CA106183 (MDT). Each of these provided financial support through grants, but none was involved in the conduct of the study.