search
Back to results

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

Primary Purpose

Prostate Cancer, Erectile Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Erythropoietin (EPO)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Erythropoietin, Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erythropoietin (EPO)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Erectile Function as Assessed by the 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.
Erectile Function as Assessed by the 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.
Erectile Function as Assessed by the 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.
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Hemoglobin Level at 2 Weeks After Surgery
Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl).
Number of Participants Requiring Transfusion During Hospitalization
Assess the number of participants requiring transfusion during hospitalization.

Full Information

First Posted
August 19, 2008
Last Updated
March 15, 2021
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT00737893
Brief Title
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Acronym
ERECT
Official Title
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Erectile Dysfunction
Keywords
Erythropoietin, Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythropoietin (EPO)
Arm Type
Experimental
Arm Description
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin (EPO)
Intervention Description
Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Primary Outcome Measure Information:
Title
Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Description
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.
Time Frame
At 6 months post-surgery
Secondary Outcome Measure Information:
Title
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Description
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.
Time Frame
At 3 months post-surgery
Title
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Description
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.
Time Frame
At 9 months post-surgery
Title
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Description
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.
Time Frame
At 12 months post-surgery
Title
Patient Score on the Overall IIEF Questionnaire
Description
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame
At 3 months post-surgery
Title
Patient Score on the Overall IIEF Questionnaire
Description
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame
At 6 months post-surgery
Title
Patient Score on the Overall IIEF Questionnaire
Description
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame
At 9 months post-surgery
Title
Patient Score on the Overall IIEF Questionnaire
Description
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame
At 12 months post-surgery
Title
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Description
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame
At 3 months post-surgery
Title
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Description
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame
At 6 months post-surgery
Title
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Description
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame
At 9 months post-surgery
Title
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Description
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame
At 12 months post-surgery
Title
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Description
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame
At 3 months post-surgery
Title
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Description
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame
At 6 months post-surgery
Title
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Description
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame
At 9 months post-surgery
Title
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Description
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame
At 12 months post-surgery
Title
Patient Score on the Quality of Erection Questionnaire (QEQ)
Description
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame
At 3 months post-surgery
Title
Patient Score on the Quality of Erection Questionnaire (QEQ)
Description
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame
At 6 months post-surgery
Title
Patient Score on the Quality of Erection Questionnaire (QEQ)
Description
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame
At 9 months post-surgery
Title
Patient Score on the Quality of Erection Questionnaire (QEQ)
Description
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame
At 12 months post-surgery
Title
Hemoglobin Level at 2 Weeks After Surgery
Description
Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl).
Time Frame
2 weeks after surgery
Title
Number of Participants Requiring Transfusion During Hospitalization
Description
Assess the number of participants requiring transfusion during hospitalization.
Time Frame
During hospital stay, up to 1 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad E Allaf, MD
Organizational Affiliation
Johns Hopkins Hospital - Brady Urological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29373284
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.
Results Reference
background
PubMed Identifier
16217394
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.
Results Reference
background
PubMed Identifier
17868418
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.
Results Reference
background
PubMed Identifier
18778310
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.
Results Reference
background
PubMed Identifier
33530745
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/20513505
Description
The preoperative use of erythropoietin stimulating proteins prior to radical prostatectomy is not associated with increased cardiovascular or thromboembolic morbidity or mortality.
URL
https://www.ncbi.nlm.nih.gov/pubmed/9372883
Description
Preoperative recombinant human erythropoietin injection versus preoperative autologous blood donation in patients undergoing radical retropubic prostatectomy.

Learn more about this trial

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

We'll reach out to this number within 24 hrs