Clinical trial · Interventional
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erythropoietin (EPO) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erythropoietin (EPO)
- description
- 20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
- interventionNames
- Drug: Erythropoietin (EPO)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDPatel 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
- BACKGROUNDAllaf 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
- BACKGROUNDLiu 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
- BACKGROUNDBurnett 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
- RESULTPatel 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