Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
Condition: Prostate Cancer, Erectile Dysfunction
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT00737893
Sponsor: Johns Hopkins University
Phase: Phase 2
- Age: minimum 40 Years maximum 65 Years
- Gender: Male
- Patient eligibility consists of men 40 to 65 years of age
- Localized prostate cancer
- clinical stage T2a or lower
- Gleason grade of 3+4 or 3+3
- prostate specific antigen (PSA) < 10
- Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
- International Index of Erectile Function-5 [IIEF-5] score of 22-25.
- The patient has a sexual partner, of at least 6 months.
- The patient's pre-surgical hematocrit is ≤ 48.
- The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.
- The patient has known penile deformity or a history of Peyronie's disease.
- The patient has planned pre or post operative androgen therapy.
- The patient has planned 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 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 phosphodiesterase type 5 (PDE 5) inhibitors.
- Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.
View trial on ClinicalTrials.gov