Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Condition: Prostate Cancer; Erectile Dysfunction
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Intervention: Placebo; Erythropoietin (EPO)
Intervention description: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.; Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: Male
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Erythropoietin; Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer

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.
    

Eligibility 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.