Phase 2
N=56
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Prostate Cancer · Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00737893 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Aug 2020
Primary outcome: Primary: Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain — 14; 19 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Erythropoietin (EPO) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain |
14; 19 | — |
| SECONDARY Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain |
22; 28 | — |
| SECONDARY Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain |
22; 28 | — |
| SECONDARY Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain |
22; 28 | — |
| SECONDARY Patient Score on the Overall IIEF Questionnaire |
53; 60.5 | — |
| SECONDARY Patient Score on the Overall IIEF Questionnaire |
53; 60.5 | — |
| SECONDARY Patient Score on the Overall IIEF Questionnaire |
53; 60.5 | — |
| SECONDARY Patient Score on the Overall IIEF Questionnaire |
53; 60.5 | — |
| SECONDARY Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) |
55.3; 55.9 | — |
| SECONDARY Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) |
55.3; 55.9 | — |
| SECONDARY Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) |
55.3; 55.9 | — |
| SECONDARY Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) |
55.3; 55.9 | — |
| SECONDARY Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain |
62.2; 73.7 | — |
| SECONDARY Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain |
62.2; 73.7 | — |
| SECONDARY Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain |
62.2; 73.7 | — |
| SECONDARY Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain |
62.2; 73.7 | — |
| SECONDARY Patient Score on the Quality of Erection Questionnaire (QEQ) |
70.8; 79.2 | — |
| SECONDARY Patient Score on the Quality of Erection Questionnaire (QEQ) |
70.8; 79.2 | — |
| SECONDARY Patient Score on the Quality of Erection Questionnaire (QEQ) |
70.8; 79.2 | — |
| SECONDARY Patient Score on the Quality of Erection Questionnaire (QEQ) |
70.8; 79.2 | — |
| SECONDARY Hemoglobin Level at 2 Weeks After Surgery |
14.7; 13.6 | — |
| SECONDARY Number of Participants Requiring Transfusion During Hospitalization |
0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00737893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.