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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737893
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 19, 2008
First Posted Date  ICMJE August 20, 2008
Results First Submitted Date  ICMJE July 29, 2020
Results First Posted Date  ICMJE August 13, 2020
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain [ Time Frame: At 6 months post-surgery ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
The primary outcome variable is the patient's score on the IIEF questionnaire. [ Time Frame: 3, 6, 9, and 12 months post-surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
  • Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain [ Time Frame: At 3 months post-surgery ]
    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 [ Time Frame: At 9 months post-surgery ]
    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 [ Time Frame: At 12 months post-surgery ]
    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 [ Time Frame: At 3 months post-surgery ]
    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 [ Time Frame: At 6 months post-surgery ]
    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 [ Time Frame: At 9 months post-surgery ]
    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 [ Time Frame: At 12 months post-surgery ]
    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) [ Time Frame: At 3 months post-surgery ]
    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) [ Time Frame: At 6 months post-surgery ]
    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) [ Time Frame: At 9 months post-surgery ]
    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) [ Time Frame: At 12 months post-surgery ]
    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 [ Time Frame: At 3 months post-surgery ]
    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 [ Time Frame: At 6 months post-surgery ]
    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 [ Time Frame: At 9 months post-surgery ]
    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 [ Time Frame: At 12 months post-surgery ]
    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) [ Time Frame: At 3 months post-surgery ]
    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) [ Time Frame: At 6 months post-surgery ]
    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) [ Time Frame: At 9 months post-surgery ]
    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) [ Time Frame: At 12 months post-surgery ]
    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 [ Time Frame: 2 weeks after surgery ]
    Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl).
  • Number of Participants Requiring Transfusion During Hospitalization [ Time Frame: During hospital stay, up to 1 week ]
    Assess the number of participants requiring transfusion during hospitalization.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
The secondary outcome variable is the patient's score on the health-related quality of life questionnaires. [ Time Frame: 6 months post-surgery at the 2-sided p=0.05 level of significance. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Official Title  ICMJE Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Erectile Dysfunction
Intervention  ICMJE
  • Drug: Placebo
    Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
  • Drug: Erythropoietin (EPO)
    Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Study Arms  ICMJE
  • Experimental: Erythropoietin (EPO)
    20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
    Intervention: Drug: Erythropoietin (EPO)
  • Placebo Comparator: Placebo
    Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2020)
56
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2008)
100
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00737893
Other Study ID Numbers  ICMJE IRB00048594
ERECT, EPO ( Other Identifier: Johns Hopkins Brady Urological Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamad E Allaf, MD Johns Hopkins Hospital - Brady Urological Institute
PRS Account Johns Hopkins University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP