View Clinical Trial (Medical Research Study)
Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21287 |
| Conditions: |
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Prostate Cancer - Erectile Dysfunction |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00737893 |
| Primary Contact: |
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Principal Investigator
Arthur L Burnett, MD
Johns Hopkins University
Irene N Trueheart, BSN
Phone: (443) 287-1011
Email: itruehe1@jhmi.edu
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| Backup Contact: |
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Email: aburnett@jhmi.edu
Arthur L Burnett, MD
Phone: (410) 955-1042
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| Location Contact: |
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Baltimore, Maryland 21287
United States
Irene N Trueheart, BSN
Phone: 443-287-1011
Email: itruehe1@jhmi.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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