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

Phase 4

Completed

• Conditions: Erectile Dysfunction; Prostate Cancer
• Interventions: Drug: Tacrolimus; Drug: Placebo

• Registration Number: NCT00106392
• Lead Sponsor: Astellas Pharma Inc

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.

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-03-23
• Study First Submitted QC: 2005-03-23
• Study First Posted: 2005-03-24
• Primary Completion: 2008-04
• Study Completion: 2008-11
• Results First Submitted: 2010-09-30
• Results First Submitted QC: 2010-09-30
• Results First Posted: 2010-10-28
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-15
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Erectile Function Domain Score Between Treated and Untreated Groups	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

Name	Time	Method
Percentage of Patients Considered Successful Responders to Impotence Medications	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.
Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score	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.
Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score	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.
Time to Achieve Response to Impotence Medications	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.
Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire	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.