LAUSR

randomized controlled trial (NCT00737893) assigning men planned to receive bilateral nerve-sparing radical prostatectomy in a 1:1 fashion to perioperative subcutaneous EPO (20,000 IU subcutaneous) or a placebo for three doses (day prior, day of, and day after surgery). Key inclusion criteria were sexually active men (IIEF-5 22 at baseline) with lowor intermediate-risk (Gleason grade 3þ4) localized prostate cancer. The primary outcome was IIEF Erectile Function domain scores (IIEF-EF) at 6-months (additionally measured at 3-, 9-, and 12-months). Secondary outcomes included other IIEF domains, the Expanded Prostate Cancer Index Composite (EPIC), Quality of Erection Questionnaire, and 12-item Short Form Health Survey. Power calculations determined 23 patients in each arm would be necessary. RESULTS: A total of 56 patients were randomized (29 EPO, 27 placebo; 50 robotic, 6 open) with well-balanced demographics and clinical parameters between arms (89.3% robotic, 83.9% Caucasian, median age 55.5 years, median operative time 148 minutes). Mean baseline IIEF-EF scores (29.2 vs. 29.3, p[0.80) were similar for the EPO and placebo arms at baseline, respectively. IIEF-EF score increased from median 12.5 at 3-months to 25 at 12-months. Perioperative outcomes were comparable. Mean 2-week serum hemoglobin was higher for the EPO arm compared to placebo among robotic patients (14.5 vs. 13.6, p[0.02). For the primary outcome, there was no statistically significant difference in mean IIEF-EF scores at 6months comparing EPO to placebo (15.3 vs. 16.9, p[0.75) or at the 3-, 9-, and 12-month timepoints. Other health-related quality of life domains and secondary outcomes were similar between arms. CONCLUSIONS: In the context of brief perioperative dosing, EPO did not improve recovery of erectile function for men undergoing radical prostatectomy for localized prostate cancer compared to placebo. Further research to identify effective adjuncts to improve healthrelated quality of life for these men is needed.