Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary outcome variable is the patient's score on the IIEF questionnaire.
3, 6, 9, and 12 months post-surgery
Arthur L Burnett, MD
Johns Hopkins University
United States: Food and Drug Administration
|Johns Hopkins Hospital||Baltimore, Maryland 21287|