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A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT00106392
Recruitment Status : Completed
First Posted : March 24, 2005
Results First Posted : October 28, 2010
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Astellas Pharma Inc

Study Description
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Brief Summary:
The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Prostate Cancer Drug: Tacrolimus Drug: Placebo Phase 4

Detailed Description:
The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
Study Start Date : February 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tacrolimus
Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
 Drug: Tacrolimus
oral
Other Name: Prograf, FK506
Placebo Comparator: Placebo
Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
 Drug: Placebo
oral


Outcome Measures
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Primary Outcome Measures :
  1. Erectile Function Domain Score Between Treated and Untreated Groups [ Time Frame: 18 months ]
    Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.


Secondary Outcome Measures :
  1. Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score [ Time Frame: 24 months ]

    Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

    Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months.


  2. Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score [ Time Frame: 24 months ]
    Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.

  3. Percentage of Patients Considered Successful Responders to Impotence Medications [ Time Frame: 24 months ]
    Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.

  4. Time to Achieve Response to Impotence Medications [ Time Frame: 24 months ]
    Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.

  5. Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire [ Time Frame: 24 months ]
    Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.


Eligibility Criteria
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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion Criteria:

  • Patient is > 65 years of age
  • Patient has been diagnosed with Type 1 or Type 2 diabetes
  • Patient is actively smoking on a daily basis
Contacts and Locations
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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): NCT00106392


Locations
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United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
New York, New York, United States, 10016
New York, New York, United States, 10021
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Central Contact Astellas Pharma US, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00106392    
Other Study ID Numbers: 20-03-001
First Posted: March 24, 2005    Key Record Dates
Results First Posted: October 28, 2010
Last Update Posted: November 23, 2010
Last Verified: November 2010
Keywords provided by Astellas Pharma Inc:
Treatment effectiveness
Treatment efficacy
Investigational, Therapies
 Immunosuppressant
Erectile dysfunction
Prostatectomy
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Tacrolimus
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action