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Statin Therapy Versus Placebo Prior to Prostatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572468
First Posted: December 13, 2007
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Screening
Conditions: Cancer
Prostate Cancer
Interventions: Drug: Simvastatin
Other: 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
Simvastatin Participants were randomized into the Simvastatin arm of this trial.
Placebo Participants were randomized into the placebo arm of this trial.

Participant Flow:   Overall Study
    Simvastatin   Placebo
STARTED   22   20 
COMPLETED   20   16 
NOT COMPLETED   2   4 



  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
Simvastatin Participants were randomized into the Simvastatin arm of this trial.
Placebo Participants were randomized into the placebo arm of this trial.
Total Total of all reporting groups

Baseline Measures
   Simvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   16   36 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16  80.0%      12  75.0%      28  77.8% 
>=65 years      4  20.0%      4  25.0%      8  22.2% 
Age 
[Units: Years]
Mean (Full Range)
 60.4 
 (46 to 71) 
 60.75 
 (53 to 73) 
 60.56 
 (46 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      20 100.0%      16 100.0%      36 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   20   16   36 


  Outcome Measures
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1.  Primary:   Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.   [ Time Frame: 5 years ]

2.  Secondary:   Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.   [ Time Frame: 2 years ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wesley Stoller
Organization: Portland VA Health Care System
phone: 503-220-8262 ext 54931
e-mail: wesley.stoller@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00572468     History of Changes
Other Study ID Numbers: CLIN-013-07S
VA IRB#1735 ( Other Identifier: VA IRB )
SOL-07130-L ( Other Identifier: OHSU Knight Cancer Institute Identifier )
First Submitted: December 11, 2007
First Posted: December 13, 2007
Results First Submitted: April 17, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017