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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106392
• Other study ID #: 20-03-001
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2005
• Last updated: November 15, 2010
• Start date: February 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer

Intervention

Drug:
• Tacrolimus
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function Domain Score Between Treated and Untreated Groups	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.	18 months	No
Secondary	Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score	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.	24 months	No
Secondary	Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score	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.	24 months	No
Secondary	Percentage of Patients Considered Successful Responders to Impotence Medications	Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.	24 months	No
Secondary	Time to Achieve Response to Impotence Medications	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.	24 months	No
Secondary	Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire	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.	24 months	No

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