Statin Therapy Versus Placebo Prior to Prostatectomy
Recruitment status was Active, not recruiting
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Purpose
| Condition | Intervention |
|---|---|
|
Cancer Prostate |
Drug: Simvastatin Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Screening |
| Official Title: | Pre-Operative Statin Therapy Versus Placebo in Human Prostate Cancer |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Twenty-two men will be on the Statin arm and take 40 mg of simvastatin.
|
Drug: Simvastatin
40 mg of simvastatin
|
|
Placebo Comparator: Arm 2
Twenty-two men will be on the placebo arm.
|
Other: Placebo
placebo
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00572468
| United States, North Carolina | |
| Durham VA Medical Center, Durham, NC | |
| Durham, North Carolina, United States, 27705 | |
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
| Principal Investigator: | Mark Garzotto, MD | VA Medical Center, Portland |
More Information
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00572468 History of Changes |
| Other Study ID Numbers: | CLIN-013-07S VA IRB#1735 SOL-07130-L |
| Study First Received: | December 11, 2007 |
| Last Updated: | August 18, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by VA Office of Research and Development:
|
cancer pre-operative surgery prostate prostatectomy radiation |
Additional relevant MeSH terms:
|
Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2016