Cellular Effect of Cholesterol-Lowering Prior to Prostate Removal

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: Male

Summary

There is evidence in human studies as well as animal studies that treatments to lower cholesterol can reduce the risk of dying from prostate cancer.To decide if cholesterol-lowering therapy can slow the growth of prostate cancer, the investigators would like to lower cholesterol prior to surgery and then measure the growth of prostate cancers cells when the prostate has been removed. The investigators will use the combination of two drugs that is approved by the U.S. Food and Drug Administration to lower cholesterol. The drug combination is commercially available with a doctor's prescription and sold as Vytorin®. It is known that maximal cholesterol-lower effects are seen after 2 weeks of treatment with Vytorin®. Therefore, study patients receive at least 2 weeks, but no more than 6 weeks of Vytorin® prior to surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: Roswell Park Cancer Institute
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

Inclusion Criteria:

• Biopsy containing ≥ 10 tissue cores sampled

• Biopsy positive for adenocarcinoma of the prostate containing any quantity of Gleason 3 component (e.g. Gleason score 3+3, 3+4, 4+3)

• Scheduled to undergo robotic radical prostatectomy

• Serum Prostate-Specific Antigen (PSA) <20 ng/ml

• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Pharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within 30 days prior to registration.

• Prior treatment for CaP by surgery, irradiation, local ablative (e.g. cryosurgery or high intensity focused ultrasound) or androgen deprivation therapy.

• 5-alpha reductase inhibitors (e.g. finasteride or dutasteride) within 180 days prior to registration.

• Hypersensitivity to simvastatin or ezetimibe.

• Pharmacologic therapy with agents reported to produce adverse drug-drug interactions. (Table 2)