A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
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
1 other identifier
interventional
131
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2005
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 23, 2005
CompletedFirst Posted
Study publicly available on registry
March 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
October 28, 2010
CompletedNovember 23, 2010
November 1, 2010
3.2 years
March 23, 2005
September 30, 2010
November 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score
24 months
Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score
24 months
Percentage of Patients Considered Successful Responders to Impotence Medications
24 months
Time to Achieve Response to Impotence Medications
24 months
Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire
24 months
Study Arms (2)
Tacrolimus
EXPERIMENTALPreoperatively: 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 COMPARATORPreoperatively: 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.
Interventions
Eligibility Criteria
You may qualify if:
- Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Houston, Texas, 77030, United States
Related Publications (1)
Mulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009.
PMID: 30224019DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Senior Medical Director, Medical Affairs
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma US, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 23, 2005
First Posted
March 24, 2005
Study Start
February 1, 2005
Primary Completion
April 1, 2008
Study Completion
November 1, 2008
Last Updated
November 23, 2010
Results First Posted
October 28, 2010
Record last verified: 2010-11