Statin Therapy Versus Placebo Prior to Prostatectomy
Completed · Not applicable · Has a placebo group
Conditions studied: Cancer, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00572468
- Run by
- VA Office of Research and Development
- People needed
- 42
- Starts
- 2007-12-01
- Expected to finish
- 2017-04-30
- Last updated by the study team
- 2017-07-13
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
- VA Medical Center, Portland — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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