Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Condition: Prostate Cancer; Erectile Dysfunction
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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 in rat models and on human urogenital tissues 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 in a prospective, randomized study.
      Erythropoietin has been used in many men undergoing open radical prostatectomy in the past
      according to FDA indications for preparation for noncardiac, nonvascular surgery with a high
      risk of blood loss. Evidence also suggests it is safe with no demonstration of increased risk
      of venous thromboembolism (blood clots) or cardiac events for men with prostate cancer
      undergoing radical prostatectomy.

      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 completed online every three months until study completion (at 3, 6, 9, and 12
      months) to assess outcomes.
    

Intervention name(s): Placebo; Erythropoietin (EPO)
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erythropoietin; Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer