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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00106392
First received: March 23, 2005
Last updated: November 15, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Erectile Dysfunction
Prostate Cancer
Drug: Tacrolimus
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Erectile Function Domain Score Between Treated and Untreated Groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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:
  • Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.


  • Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients Considered Successful Responders to Impotence Medications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.

  • Time to Achieve Response to Impotence Medications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 131
Study Start Date: February 2005
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106392

Locations
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
New York, New York, United States, 10021
New York, New York, United States, 10016
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
Study Director: Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00106392     History of Changes
Other Study ID Numbers: 20-03-001
Study First Received: March 23, 2005
Results First Received: September 30, 2010
Last Updated: November 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Treatment effectiveness
Treatment efficacy
Investigational, Therapies
Immunosuppressant
Erectile dysfunction
Prostatectomy

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
Sexual and Gender Disorders
Mental Disorders
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014