Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy (EPO)
This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer.
Pre-clinical studies in a rat model showed erythropoietin potently promoted recovery of erectile function.
The hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy resulting in a reduced time of erectile dysfunction and also an improved rate of erection recovery following surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy|
- The primary outcome variable is the patient's score on the (IIEF) International Index of Erectile Function questionnaire. [ Time Frame: 3, 6, 9, and 12 months post-surgery ] [ Designated as safety issue: No ]
- The secondary outcome variable is the patient's score on the health-related quality of life questionnaires. [ Time Frame: 6 months post-surgery at the 2-sided p=0.05 level of significance. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Erythropoietin 20,000 units subcutaneously given pre-op day, day of surgery, day after surgery.
|Placebo Comparator: B||
Saline injection subcutaneously given pre-op day, day of surgery, day after surgery.
This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical prostatectomy for prostate cancer.
Recent laboratory findings suggest, that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively.
The length of the study is 12 months and involves receiving a dose of study drug or placebo on the day before surgery, the day of surgery, and the day following surgery. The dose is given by subcutaneous injection. The study will also require the completion of questionnaires which will be mailed every three months until study completion.
|Contact: Jordan Dimitrakoff, M.D., Ph.D.||(410) firstname.lastname@example.org|
|Contact: Arthur L Burnett, MD||(410) email@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Jordan Dimitrakoff, M.D., Ph.D. 410-502-5384 firstname.lastname@example.org|
|Contact: Brian Le, M.D. email@example.com|
|Principal Investigator: Arthur L Burnett, M.D., MBA|
|Sub-Investigator: Patrick C Walsh, MD|
|Sub-Investigator: Mohamad E Allaf, MD|
|Sub-Investigator: Trinity Bivalacqua, M.D., Ph.D.|
|Sub-Investigator: Jordan Dimitrakoff, M.D., Ph.D.|
|Sub-Investigator: Brian Le, M.D.|
|Principal Investigator:||Arthur L Burnett, MD||Johns Hopkins University|