Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy (EPO)

This study is currently recruiting participants.
Verified September 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00737893
First received: August 19, 2008
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 in a rat model showed erythropoietin potently promoted recovery of erectile function.

The hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy resulting in a reduced time of erectile dysfunction and also an improved rate of erection recovery following surgery.


Condition Intervention Phase
Prostate Cancer
Erectile Dysfunction
Drug: Placebo
Drug: EPO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The primary outcome variable is the patient's score on the (IIEF) International Index of Erectile Function questionnaire. [ Time Frame: 3, 6, 9, and 12 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome variable is the patient's score on the health-related quality of life questionnaires. [ Time Frame: 6 months post-surgery at the 2-sided p=0.05 level of significance. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: EPO
Erythropoietin 20,000 units subcutaneously given pre-op day, day of surgery, day after surgery.
Placebo Comparator: B Drug: Placebo
Saline injection subcutaneously given pre-op day, day of surgery, day after 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 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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient eligibility consists of men 40 to 65 years of age
  • Localized prostate cancer

    • clinical stage < T2a
    • Gleason grade < 7
    • PSA (prostate specific antigen) < 10
  • Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
  • International Index of Erectile Function [IIEF], erectile function domain score > 26
  • Otherwise meeting the following exclusion/inclusion criteria.
  • The patient has a sexual partner, of at least 6 months.
  • The patient's pre-surgical hematocrit is ≤ 48.
  • The patient answered 5-6 times or greater to question #6 on the IIEF.

Exclusion Criteria:

  • The patient has known penile deformity or a history of Peyronie's disease.
  • The patient has had pre or post operative androgen therapy.
  • The patient has had 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 of diabetes, 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 PDE 5(phosphodiesterase type 5) inhibitors.
  • The patient is currently participating in another clinical investigation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737893

Contacts
Contact: Jordan Dimitrakoff, M.D., Ph.D. (410) 502-5384 jdimitr1@jhmi.edu
Contact: Arthur L Burnett, MD (410) 955-1042 aburnett@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jordan Dimitrakoff, M.D., Ph.D.    410-502-5384    jdimitr1@jhmi.edu   
Contact: Brian Le, M.D.       ble6@jhmi.edu   
Principal Investigator: Arthur L Burnett, M.D., MBA         
Sub-Investigator: Patrick C Walsh, MD         
Sub-Investigator: Mohamad E Allaf, MD         
Sub-Investigator: Trinity Bivalacqua, M.D., Ph.D.         
Sub-Investigator: Jordan Dimitrakoff, M.D., Ph.D.         
Sub-Investigator: Brian Le, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Arthur L Burnett, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Arthur L. Burnett, M.D., Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00737893     History of Changes
Other Study ID Numbers: NA_00010941
Study First Received: August 19, 2008
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Erythropoietin
Radical Prostatectomy
Erectile Dysfunction
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014