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Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy (EPO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00737893
First received: August 19, 2008
Last updated: January 18, 2017
Last verified: January 2017

August 19, 2008
January 18, 2017
June 2008
December 2019   (Final data collection date for primary outcome measure)
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.
The primary outcome variable is the patient's score on the IIEF questionnaire. [ Time Frame: 3, 6, 9, and 12 months post-surgery ]
Complete list of historical versions of study NCT00737893 on ClinicalTrials.gov Archive Site
  • 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
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. ]
Not Provided
Not Provided
 
Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy
Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy

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 in a rat model showed erythropoietin potently promoted recovery of erectile function.

The hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy resulting in a reduced time of erectile dysfunction and also an improved rate of erection recovery following surgery.

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 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.

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 mailed, emailed, or done online every three months until study completion.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Prostate Cancer
  • Erectile Dysfunction
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2019
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient eligibility consists of men 40 to 65 years of age
  • Localized prostate cancer

    • clinical stage < T2a
    • Gleason grade < 7
    • 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 [IIEF], erectile function domain score > 26
  • Otherwise meeting the following exclusion/inclusion criteria.
  • The patient has a sexual partner, of at least 6 months.
  • The patient's pre-surgical hematocrit is ≤ 48.
  • The patient answered 5-6 times or greater to question #6 on the IIEF.

Exclusion Criteria:

  • The patient has known penile deformity or a history of Peyronie's disease.
  • The patient has had pre or post operative androgen therapy.
  • The patient has had 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.
Sexes Eligible for Study: Male
40 Years to 65 Years   (Adult)
No
Contact: Hiten D Patel, MD, MPH 410-502-7710 hitenpatel@jhmi.edu
Contact: Mohamad E Allaf, MD 10-502-7710 mallaf@jhmi.edu
United States
 
 
NCT00737893
IRB00048594
No
Not Provided
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Mohamad E Allaf, MD Johns Hopkins Hospital - Brady Urological Institute
Johns Hopkins University
January 2017

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