Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT00737893
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT00737893
Study Brief:
Protocol Section:
NCT00737893