Clinical trial NCT00737893: Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Official title: Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Erectile Dysfunction
Keywords: Erythropoietin
Radical Prostatectomy
Erectile Dysfunction
Prostate Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 56
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function.

Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.

Detailed description: 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.

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.

Primary outcomes:
measure: Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
timeFrame: At 6 months post-surgery
Secondary outcomes:
measure: Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
timeFrame: At 3 months post-surgery
measure: Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
timeFrame: At 9 months post-surgery
measure: Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
timeFrame: At 12 months post-surgery
measure: Patient Score on the Overall IIEF Questionnaire
timeFrame: At 3 months post-surgery
measure: Patient Score on the Overall IIEF Questionnaire
timeFrame: At 6 months post-surgery
measure: Patient Score on the Overall IIEF Questionnaire
timeFrame: At 9 months post-surgery
measure: Patient Score on the Overall IIEF Questionnaire
timeFrame: At 12 months post-surgery
measure: Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
timeFrame: At 3 months post-surgery
measure: Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
timeFrame: At 6 months post-surgery
measure: Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
timeFrame: At 9 months post-surgery
measure: Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
timeFrame: At 12 months post-surgery
measure: Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
timeFrame: At 3 months post-surgery
measure: Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
timeFrame: At 6 months post-surgery
measure: Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
timeFrame: At 9 months post-surgery
measure: Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
timeFrame: At 12 months post-surgery
measure: Patient Score on the Quality of Erection Questionnaire (QEQ)
timeFrame: At 3 months post-surgery
measure: Patient Score on the Quality of Erection Questionnaire (QEQ)
timeFrame: At 6 months post-surgery
measure: Patient Score on the Quality of Erection Questionnaire (QEQ)
timeFrame: At 9 months post-surgery
measure: Patient Score on the Quality of Erection Questionnaire (QEQ)
timeFrame: At 12 months post-surgery
measure: Hemoglobin Level at 2 Weeks After Surgery
timeFrame: 2 weeks after surgery
measure: Number of Participants Requiring Transfusion During Hospitalization
timeFrame: During hospital stay, up to 1 week
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Hospital - Brady Urological Institute
name: Mohamad E Allaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel HD, Allaf ME. Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: The ERECT Trial. Eur Urol Focus. 2019 Jul;5(4):698-699. doi: 10.1016/j.euf.2018.01.002. Epub 2018 Jan 17.
citation: Allaf ME, Hoke A, Burnett AL. Erythropoietin promotes the recovery of erectile function following cavernous nerve injury. J Urol. 2005 Nov;174(5):2060-4. doi: 10.1097/01.ju.0000176808.94610.dd.
citation: Liu T, Allaf ME, Lagoda G, Burnett AL. Erythropoietin receptor expression in the human urogenital tract: immunolocalization in the prostate, neurovascular bundle and penis. BJU Int. 2007 Nov;100(5):1103-6. doi: 10.1111/j.1464-410X.2007.07194.x. Epub 2007 Sep 14.
citation: Burnett AL, Allaf ME, Bivalacqua TJ. Erythropoietin promotes erection recovery after nerve-sparing radical retropubic prostatectomy: a retrospective analysis. J Sex Med. 2008 Oct;5(10):2392-8. doi: 10.1111/j.1743-6109.2008.00980.x. Epub 2008 Sep 5.
citation: Patel HD, Schwen ZR, Campbell JD, Gorin MA, Partin AW, Burnett AL, Allaf ME. Effect of Erythropoietin on Erectile Function after Radical Prostatectomy: The ERECT Randomized Clinical Trial. J Urol. 2021 Jun;205(6):1681-1688. doi: 10.1097/JU.0000000000001586. Epub 2021 Feb 3.