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.
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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