Overview

This trial is active, not recruiting.

Conditions cancer, prostate
Treatments simvastatin, placebo
Sponsor Department of Veterans Affairs
Collaborator Oregon Health and Science University
Start date December 2007
End date October 2013
Trial size 44 participants
Trial identifier NCT00572468, CLIN-013-07S, SOL-07130-L, VA IRB#1735

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose screening
Arm
(Active Comparator)
Twenty-two men will be on the Statin arm and take 40 mg of simvastatin.
simvastatin
40 mg of simvastatin
(Placebo Comparator)
Twenty-two men will be on the placebo arm.
placebo
placebo

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants at least 21 years old.

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

Additional Information

Official title Pre-Operative Statin Therapy Versus Placebo in Human Prostate Cancer
Principal investigator Mark Garzotto, MD
Description Prostate cancer patients that have chosen to undergo a prostatectomy as their primary treatment option will be recruited to this trial. Forty-four subjects will be randomized to either placebo or simvastatin (40 mg po/day) for 4 weeks prior to surgery. Serum samples will be obtained at baseline and immediately prior to prostatectomy. At prostatectomy, cancerous and benign prostate tissue will be microdissected and cryopreserved. Archival prostatectomy tissues will be used to construct tissue microarrays containing matched benign and malignant sections. The effect of HMG-CoA reductase inhibition on lipid raft cholesterol content and targets of prenylation will be determined. The incidence of apoptosis will be determined along with protein levels of mediators of apoptosis. Lastly the effect of statin therapy on cellular markers of proliferation will be determined. Previously, we studied the effect of statin use on the risk of prostate cancer detection in a case-control study at the Portland VA Medical Center. Statin use was associated with a 62% reduction in cancer odds-risk (OR = 0.38, 95% CI 0.21-0.69). Although these epidemiologic and laboratory findings have generated enthusiasm for the study of statins in prostate cancer, no studies have examined the biologic effects of statins on prostate cancer in humans. Hypothesis: Statin therapy prior to prostatectomy will successfully target the mevalonate pathway in the human prostate and this intervention will favorably alter tumor biomarker status.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.