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
Results First Received: September 30, 2010  
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
Conditions: Erectile Dysfunction
Prostate Cancer
Interventions: Drug: Tacrolimus
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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 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.

Participant Flow:   Overall Study
    Tacrolimus     Placebo  
STARTED     62     69  
Baseline Participants     59 [1]   65 [2]
Full Analysis Set (FAS)     53     61  
COMPLETED     36     42  
NOT COMPLETED     26     27  
[1] 3 patients withdrew: 2 prior to surgery and study drug; 1 took study drug but did not have surgery
[2] 4 patients withdrew: all prior to surgery and study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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 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.
Total Total of all reporting groups

Baseline Measures
    Tacrolimus     Placebo     Total  
Number of Participants  
[units: participants]
  59     65     124  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 6.2     54.1  ± 6.2     54.6  ± 6.2  
Gender  
[units: participants]
     
Female     0     0     0  
Male     59     65     124  
Race/Ethnicity, Customized  
[units: Participants]
     
American Indian or Alaskan Native     0     1     1  
Black or African American     4     1     5  
White     55     63     118  



  Outcome Measures
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1.  Primary:   Erectile Function Domain Score Between Treated and Untreated Groups   [ Time Frame: 18 months ]

2.  Secondary:   Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score   [ Time Frame: 24 months ]

3.  Secondary:   Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score   [ Time Frame: 24 months ]

4.  Secondary:   Percentage of Patients Considered Successful Responders to Impotence Medications   [ Time Frame: 24 months ]

5.  Secondary:   Time to Achieve Response to Impotence Medications   [ Time Frame: 24 months ]
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Measure Type Secondary
Measure Title Time to Achieve Response to Impotence Medications
Measure Description 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.
Time Frame 24 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who had a successful response to impotence medications were included in the calculations.


Reporting Groups
  Description
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 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.

Measured Values
    Tacrolimus     Placebo  
Number of Participants Analyzed  
[units: participants]
  38     50  
Time to Achieve Response to Impotence Medications  
[units: Days]
Median ( Full Range )
  102.0  
  ( 34.0 to 730.0 )  
  113.5  
  ( 29.0 to 821.0 )  


Statistical Analysis 1 for Time to Achieve Response to Impotence Medications
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.575
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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6.  Secondary:   Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


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