Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy
40 Years
59 Years
Male
Prostate Cancer, Erectile Dysfunction
Trial Information
Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
The primary outcome variable is the patient's score on the IIEF questionnaire.
Outcome Time Frame:
3, 6, 9, and 12 months post-surgery
Safety Issue:
No
Principal Investigator
Arthur L Burnett, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Food and Drug Administration
Study ID:
NA_00010941
NCT ID:
NCT00737893
Start Date:
June 2008
Completion Date:
January 2016
Related Keywords:
- Prostate Cancer
- Erectile Dysfunction
- Erythropoietin
- Radical Prostatectomy
- Erectile Dysfunction
- Prostate Cancer
- Prostatic Neoplasms
- Erectile Dysfunction
Name | Location |
|---|---|
| Johns Hopkins Hospital | Baltimore, Maryland 21287 |
