MP45-11 EFFECT OF ERYTHROPOIETIN ON ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY: THE ERECT RANDOMIZED CLINICAL TRIAL (2020)

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (MP45)1 Apr 2020MP45-11 EFFECT OF ERYTHROPOIETIN ON ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY: THE ERECT RANDOMIZED CLINICAL TRIAL Hiten Patel*, Zeyad Schwen, Jeffrey Campbell, Michael Gorin, Alan Partin, Arthur Burnett, and Mohamad Allaf Hiten Patel*Hiten Patel* More articles by this author , Zeyad SchwenZeyad Schwen More articles by this author , Jeffrey CampbellJeffrey Campbell More articles by this author , Michael GorinMichael Gorin More articles by this author , Alan PartinAlan Partin More articles by this author , Arthur BurnettArthur Burnett More articles by this author , and Mohamad AllafMohamad Allaf More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000900.011AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Erythropoietin (EPO), a glycosylated cytokine-hormone, was demonstrated to be a neurotrophic factor for neurogenic erectile dysfunction based on a cavernous nerve injury rat model. Based on promising preliminary findings in humans, we conducted a randomized controlled trial to assess the effect of perioperative subcutaneous EPO on recovery of erectile function for men undergoing radical prostatectomy for localized prostate cancer. METHODS: ERECT is a double-blind, prospective, phase II 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 low- or intermediate-risk (Gleason grade ≤3+4) 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 6-months 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 health-related quality of life for these men is needed. Source of Funding: The study was supported by funding from the James Buchanan Brady Urological Institute Minimally Invasive Urology Fund. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e668-e669 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hiten Patel* More articles by this author Zeyad Schwen More articles by this author Jeffrey Campbell More articles by this author Michael Gorin More articles by this author Alan Partin More articles by this author Arthur Burnett More articles by this author Mohamad Allaf More articles by this author Expand All Advertisement PDF downloadLoading ...