Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

Inclusion criteria

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as:

• ≥ 50 years of age
• Hypertension
• Hypercholesterolemia
• Diabetes
• Current or former smoker
• First-degree family history of any cardiovascular heart disease
• BMI > 25
• On hypertension treatment, statin, and/or aspirin therapy
• Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as:

• Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml
• Clinical stage T1c or cT2
• Gleason score 3+3 or 3+4 or 4+3
• Patients on AS with plans for surveillance biopsy
• No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
• Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe.
• Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration.

Exclusion criteria

• Current use of medications contraindicated for use with a statin such as strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
• Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol).
• History of allergic or severe reaction to a either study agent.
• History of moderate or severe myalgia with statin use.
• Acute liver failure or decompensated cirrhosis
• Already on maximum VYTORIN dose (10/80)
• Already on medication(s) known to interact with Vytorin or Ezetimibe that may prevent protocol-based escalation of cholesterol-lowering therapy from pre-enrollment baseline.
• Already on a PCSK9 inhibitor