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Trial record 8 of 59924 for:    Placebo

Statin Therapy Versus Placebo Prior to Prostatectomy

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.
 
ClinicalTrials.gov Identifier: NCT00572468
Recruitment Status : Completed
First Posted : December 13, 2007
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

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
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description Participants were randomized into the Simvastatin arm of this trial. Participants were randomized into the placebo arm of this trial.
Period Title: Overall Study
Started 22 20
Completed 20 16
Not Completed 2 4
Arm/Group Title Simvastatin Placebo Total
Hide Arm/Group Description Participants were randomized into the Simvastatin arm of this trial. Participants were randomized into the placebo arm of this trial. Total of all reporting groups
Overall Number of Baseline Participants 20 16 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 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, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 16 participants 36 participants
60.4
(46 to 71)
60.75
(53 to 73)
60.56
(46 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
16
 100.0%
36
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 16 participants 36 participants
20 16 36
1.Primary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description:
Participants were randomized into the Simvastatin arm of this trial.
Participants were randomized into the placebo arm of this trial.
Overall Number of Participants Analyzed 15 11
Mean (95% Confidence Interval)
Unit of Measure: Percentage of cells
168.6666667
(142.4517 to 194.882)
182.7272727
(161.46353 to 203.99107)
2.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description:
Participants were randomized into the Simvastatin arm of this trial.
Participants were randomized into the placebo arm of this trial.
Overall Number of Participants Analyzed 15 11
Mean (95% Confidence Interval)
Unit of Measure: Percentage of cells
7.53333
(3.95134 to 11.11532)
6
(1.87843 to 10.12157)
Time Frame Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description Participants were randomized into the Simvastatin arm of this trial. Participants were randomized into the placebo arm of this trial.
All-Cause Mortality
Simvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/20 (55.00%)      3/16 (18.75%)    
Cardiac disorders     
Hypotension  1/20 (5.00%)  1 1/16 (6.25%)  1
Gastrointestinal disorders     
Nausea  0/20 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Wound infection  1/20 (5.00%)  1 0/16 (0.00%)  0
Bloody drainage from wound  1/20 (5.00%)  1 0/16 (0.00%)  0
Renal and urinary disorders     
UTI  4/20 (20.00%)  4 1/16 (6.25%)  1
Catheter discomfort  1/20 (5.00%)  1 1/16 (6.25%)  1
Reproductive system and breast disorders     
Penile pain  3/20 (15.00%)  3 0/16 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/16 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Wesley Stoller
Organization: Portland VA Health Care System
Phone: 503-220-8262 ext 54931
EMail: wesley.stoller@va.gov
Layout table for additonal information
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