This phase II trial studies how well erythropoietin works in the recovery of erectile dysfunction in men with localized prostate cancer after a radical prostatectomy (surgery to remove the prostate). Giving erythropoietin may help protect the nerves which could result in a reduced amount of time of erectile dysfunction and an improved rate of erection recovery after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00737893.
PRIMARY OBJECTIVE:
I. To evaluate the effect of short-term perioperative recombinant human erythropoietin administration on erectile function recovery in men undergoing bilateral nerve-sparing radical prostatectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive erythropoietin subcutaneously (SC) on the day before surgery, the day of surgery, and the day after surgery in the absence of unacceptable toxicity.
ARM II: Patients receive a placebo SC on the day before surgery, the day of surgery, and the day after surgery in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks and then at 1, 3, 6, 9, and 12 months after surgery.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMohamad E. Allaf
