Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy (EPO)
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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 |
- The primary outcome variable is the patient's score on the IIEF questionnaire. [ Time Frame: 3, 6, 9, and 12 months post-surgery ] [ Designated as safety issue: No ]
- 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 2016 |
| Estimated Primary Completion Date: | January 2015 (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 59 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient eligibility consists of men 40 to 59 years of age
Localized prostate cancer
- clinical stage < T2a
- Gleason grade < 7
- PSA < 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's Body Mass Index is less than 30.
- 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.
- 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 inhibitors.
- The patient is currently participating in another clinical investigation
Contacts and Locations| Contact: Irene N Trueheart, BSN | (443) 287-1011 | itruehe1@jhmi.edu |
| Contact: Arthur L Burnett, MD | (410) 955-1042 | aburnett@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Irene N Trueheart, BSN 443-287-1011 itruehe1@jhmi.edu | |
| Principal Investigator: Arthur L Burnett, MD | |
| Sub-Investigator: Patrick C Walsh, MD | |
| Sub-Investigator: Mohamad E Allaf, MD | |
| Sub-Investigator: Trinity Bivalacqua, MD | |
| Sub-Investigator: Robert Segal, MD | |
| 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: | January 14, 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 May 16, 2013