Statin Therapy Versus Placebo Prior to Prostatectomy

• Status: Completed
• Trial end date: 2017-04-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Oregon Health and Science University
• Treatments: Simvastatin

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