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Statin Therapy Versus Placebo Prior to Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00572468
First received: December 11, 2007
Last updated: August 18, 2014
Last verified: August 2014

December 11, 2007
August 18, 2014
December 2007
October 2013   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue.
Complete list of historical versions of study NCT00572468 on ClinicalTrials.gov Archive Site
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 ]
Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy.
Not Provided
Not Provided
 
Statin Therapy Versus Placebo Prior to Prostatectomy
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
  • Cancer
  • Prostate
  • Drug: Simvastatin
    40 mg of simvastatin
  • Other: Placebo
    placebo
  • Active Comparator: Arm 1
    Twenty-two men will be on the Statin arm and take 40 mg of simvastatin.
    Intervention: Drug: Simvastatin
  • Placebo Comparator: Arm 2
    Twenty-two men will be on the placebo arm.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
December 2014
October 2013   (final data collection date for primary outcome measure)

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
Male
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00572468
CLIN-013-07S, VA IRB#1735, SOL-07130-L
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Oregon Health and Science University
Principal Investigator: Mark Garzotto, MD VA Medical Center, Portland
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP