We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified July 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737893
First Posted: August 20, 2008
Last Update Posted: July 26, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Erectile Dysfunction Drug: Placebo Drug: Erythropoietin (EPO) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The primary outcome variable is the patient's score on the (IIEF) International Index of Erectile Function questionnaire erectile function domain (scale of 30 points) [ Time Frame: Surveys completed at 6 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months) as well as the computed change over time in scores (slope) to estimate recovery over time (utilizing all available scores for each patient). The primary outcome will be scores compared at the survey closest to 6 months after surgery. Scores at 3, 9, and 12 months will be secondary outcomes.


Secondary Outcome Measures:
  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire erectile function domain (scale of 30 points) [ Time Frame: Surveys completed at 3 months post-surgery ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months) as well as the computed change over time in scores (slope) to estimate recovery over time (utilizing all available scores for each patient). The primary outcome will be scores compared at the survey closest to 6 months after surgery. Scores at 3, 9, and 12 months will be secondary outcomes.

  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire erectile function domain (scale of 30 points) [ Time Frame: Surveys completed at 9 months post-surgery ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months) as well as the computed change over time in scores (slope) to estimate recovery over time (utilizing all available scores for each patient). The primary outcome will be scores compared at the survey closest to 6 months after surgery. Scores at 3, 9, and 12 months will be secondary outcomes.

  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire erectile function domain (scale of 30 points) [ Time Frame: Surveys completed at 12 months post-surgery ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months) as well as the computed change over time in scores (slope) to estimate recovery over time (utilizing all available scores for each patient). The primary outcome will be scores compared at the survey closest to 6 months after surgery. Scores at 3, 9, and 12 months will be secondary outcomes.

  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire for domains other than erectile function (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction). [ Time Frame: Surveys will be completed at 3 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire for domains other than erectile function (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction). [ Time Frame: Surveys will be completed at 6 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire for domains other than erectile function (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction). [ Time Frame: Surveys will be completed at 9 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the (IIEF) International Index of Erectile Function questionnaire for domains other than erectile function (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction). [ Time Frame: Surveys will be completed at 12 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on health-related quality of life questionnaires (SF-12) [ Time Frame: Surveys will be completed at 3 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on health-related quality of life questionnaires (SF-12) [ Time Frame: Surveys will be completed at 6 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on health-related quality of life questionnaires (SF-12) [ Time Frame: Surveys will be completed at 9 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on health-related quality of life questionnaires (SF-12) [ Time Frame: Surveys will be completed at 12 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: Surveys will be completed at 3 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: Surveys will be completed at 6 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: Surveys will be completed at 9 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: Surveys will be completed at 12 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Quality of Erection Questionnaire (QEQ) [ Time Frame: Surveys will be completed at 3 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Quality of Erection Questionnaire (QEQ) [ Time Frame: Surveys will be completed at 6 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Quality of Erection Questionnaire (QEQ) [ Time Frame: Surveys will be completed at 9 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Patient's score on the Quality of Erection Questionnaire (QEQ) [ Time Frame: Surveys will be completed at 12 months post-surgery. ]
    Scores will be compared at these established time points (3, 6, 9, and 12 months).

  • Change in hemoglobin level from preoperative to postoperative day one [ Time Frame: 1 day after surgery ]
    Measured as the difference between hemoglobin on the day after surgery compared to the patient's documented preoperative level (within 30 days of surgery)

  • Transfusion requirement during hospitalization [ Time Frame: Length of hospital stay up to 1 week ]
    The total number of transfused packed red blood cell units during hospitalization


Estimated Enrollment: 50
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin (EPO)
20,000 units of EPO given on the day before surgery, the 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.
Placebo Comparator: Placebo
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Drug: Placebo
Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737893


Contacts
Contact: Hiten D Patel, MD, MPH 410-502-7710 hitenpatel@jhmi.edu
Contact: Mohamad E Allaf, MD 10-502-7710 mallaf@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Hiten D Patel, MD, MPH    410-502-7710    hitenpatel@jhmi.edu   
Contact: Mohamad E Allaf, MD    410-502-7710    mallaf@jhmi.edu   
Sub-Investigator: Mohamad E Allaf, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mohamad E Allaf, MD Johns Hopkins Hospital - Brady Urological Institute
  More Information

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00737893     History of Changes
Other Study ID Numbers: IRB00048594
ERECT, EPO ( Other Identifier: Johns Hopkins Brady Urological Institute )
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Erythropoietin
Radical Prostatectomy
Erectile Dysfunction
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Epoetin Alfa
Hematinics