Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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 have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function.

Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patient eligibility consists of men 40 to 65 years of age

• Localized prostate cancer

• clinical stage T2a or lower

• Gleason grade of 3+4 or 3+3

• prostate specific antigen (PSA) < 10

• Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function

• International Index of Erectile Function-5 (IIEF-5) score of 22-25.

• The patient has a sexual partner, of at least 6 months.

• The patient's pre-surgical hematocrit is ≤ 48.

• The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.

Exclusion Criteria:

• The patient has known penile deformity or a history of Peyronie's disease.

• The patient has planned pre or post operative androgen therapy.

• The patient has planned pre or post operative radiation therapy.

• The patient is on anticoagulation therapy.

• The patient has a history of sickle cell anemia.

• The patient has a history of high or low blood pressure that is not controlled.

• The patient is taking medications called "nitrates"

• The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction

• The patient has a history of history of drug or alcohol abuse.

• The patient currently smokes or has a 20 pack/year history of cigarette smoking.

• The patient has a history of acute or chronic depression

• The patient has a history liver problems, or kidney problems.

• The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.

• The patient has a history of spinal trauma or surgery to the brain or spinal cord.

• The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.

• Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.