N/A
N=42
Statin Therapy Versus Placebo Prior to Prostatectomy
Cancer · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00572468 ↗Enrolled (actual)
42
Serious AEs
38.9%
Results posted
Jul 2017
Primary outcome: Primary: Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue. — 168.6666667; 182.7272727 Percentage of cells
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Simvastatin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue. |
168.6666667; 182.7272727 | — |
| SECONDARY Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy. |
7.53333; 6 | — |
Summary
This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets of the mevalonate pathway in men undergoing a prostatectomy as planned management for prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol and low-density lipoprotein.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7)
- Radical prostatectomy chosen as primary treatment for prostate cancer
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy)
- Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
- History of or active liver disease or abnormal results of the baseline liver function test (> 2 x normal)
- Current use of:
- simvastatin
- lovastatin
- other HMG-CoA inhibitors
- lipid-lowering agents
- Amiodarone
- Cholestyramine
- Cholestyramine and colestipol (bile acid sequestrants)
- Clofibrate and fenofibrate
- Cyclosporine
- CYP3A4 inhibitors
- Danazol
- Diltiazem
- Gemfibrozil
- Niacin ( 1 g/day)
- Verapamil and Warfarin
- Known allergy or sensitivity to ingredients in simvastatin
Data sourced from ClinicalTrials.gov (NCT00572468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.