Erythropoietin to Enhance Recovery of Erectile Function 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 in rat models and on human urogenital tissues 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 in a prospective, randomized study.
Erythropoietin has been used in many men undergoing open radical prostatectomy in the past
according to FDA indications for preparation for noncardiac, nonvascular surgery with a high
risk of blood loss. Evidence also suggests it is safe with no demonstration of increased risk
of venous thromboembolism (blood clots) or cardiac events for men with prostate cancer
undergoing radical prostatectomy.

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 completed online every three months until study completion (at 3, 6, 9, and 12
months) to assess outcomes.

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.