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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06437574

Run by

Cedars-Sinai Medical Center

People needed

140

Starts

2024-07-16

Expected to finish

2028-05-31

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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