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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


Phase 4
N/A
65 Years
Not Enrolling
Male
Erectile Dysfunction, Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

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

Outcome Measure:

Erectile Function Domain Score Between Treated and Untreated Groups

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma US, Inc.

Authority:

United States: Institutional Review Board

Study ID:

20-03-001

NCT ID:

NCT00106392

Start Date:

February 2005

Completion Date:

November 2008

Related Keywords:

  • Erectile Dysfunction
  • Prostate Cancer
  • Treatment effectiveness
  • Treatment efficacy
  • Investigational, Therapies
  • Immunosuppressant
  • Erectile dysfunction
  • Prostatectomy
  • Prostatic Neoplasms
  • Erectile Dysfunction

Name

Location

Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Flint, Michigan  48532