Cancer Clinical Trial
Official title:
Pre-Operative Statin Therapy Versus Placebo in Human Prostate Cancer
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening
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