Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes
Cedars-Sinai Medical Center
Summary
To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C \<70 mg/dl. Dose adjustment is not allowed for ezetimibe.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as: 1. ≥ 50 years of age 2. Hypertension 3. Hypercholesterolemia 4. Diabetes 5. Current or former smoker 6. First-degree family history of any cardiovascular heart disease 7. BMI \> 25 8. On hypertension treatment, statin, and/or aspirin therapy 4. Patients with clinically localized prostate cancer. That is Lo…
Interventions
- DrugVytorin
Vytorin is a drug combination (Ezetimibe and Simvastatin) that targets the two primary sources of cholesterol, absorption in the gut and synthesis in the liver.
- DrugEzetimibe
Ezetimibe is a drug that targets one of the primary sources of cholesterol, absorption in the gut.
Location
- Cedars-Sinai Medical CenterLos Angeles, California