Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy

NCT00737893 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00048594ERECT, EPO
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Erectile Dysfunction

Keywords

Erythropoietin; Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain

  Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.

  At 6 months post-surgery

Secondary Outcomes (21)

• Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain

  At 3 months post-surgery

• Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain

  At 9 months post-surgery

• Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain

  At 12 months post-surgery

• Patient Score on the Overall IIEF Questionnaire

  At 3 months post-surgery

• Patient Score on the Overall IIEF Questionnaire

  At 6 months post-surgery

Study Arms (2)

Erythropoietin (EPO)

EXPERIMENTAL

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Drug: Erythropoietin (EPO)

Placebo

PLACEBO COMPARATOR

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Drug: Placebo

Interventions

Placebo DRUG

Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo

Erythropoietin (EPO) DRUG

Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Erythropoietin (EPO)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (5)

• 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.

  PMID: 29373284 BACKGROUND

• 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.

  PMID: 16217394 BACKGROUND

• 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.

  PMID: 17868418 BACKGROUND

• 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.

  PMID: 18778310 BACKGROUND

• 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.

  PMID: 33530745 RESULT

Related Links

• The preoperative use of erythropoietin stimulating proteins prior to radical prostatectomy is not associated with increased cardiovascular or thromboembolic morbidity or mortality.
• Preoperative recombinant human erythropoietin injection versus preoperative autologous blood donation in patients undergoing radical retropubic prostatectomy.

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Hiten Patel
• Organization: Johns Hopkins Brady Urological Institute

hiten.patel@lumc.edu

410-502-7710

Study Officials

• Mohamad E Allaf, MD

  Johns Hopkins Hospital - Brady Urological Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: July 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 8, 2021
• Results First Posted: August 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)