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

Sponsor: Cedars-Sinai Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06437574

Provider View

This clinical trial is exploring whether lowering cholesterol intensively can help the immune system fight prostate cancer. The study involves prostate cancer patients who are under active surveillance and will have a biopsy in 3-6 months.

Patient Parameters

Program Overview

The purpose of this study is to see if lowering cholesterol levels intensively can help the immune system fight prostate cancer. The trial will include patients with prostate cancer who are being closely monitored and are scheduled for a biopsy in the next 3-6 months. Participants will take a cholesterol-lowering medication called Vytorin®, which is a combination of ezetimibe and simvastatin, or just ezetimibe. The goal is to reduce LDL cholesterol to less than 70 mg/dl. The starting dose will depend on the patient's current cholesterol levels and any statin use.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed and dated consent to participate.
  • Willing to follow all study procedures and be available for the study duration.
  • Have at least one risk factor for heart disease, such as:
    • Age 50 or older
    • High blood pressure
    • High cholesterol
    • Diabetes
    • Current or past smoker
    • Family history of heart disease
    • BMI over 25
    • Taking medication for high blood pressure, cholesterol, or aspirin
  • Have localized prostate cancer with low or intermediate risk, defined by:
    • PSA level 20 ng/ml or lower
    • Clinical stage T1c or cT2
    • Gleason score of 3+3, 3+4, or 4+3
  • Undergoing active surveillance with plans for a biopsy
  • No previous treatment for prostate cancer with radiation, chemotherapy, or hormone therapy
  • Able to take oral medication and willing to take Vytorin or ezetimibe daily
  • Agree to avoid grapefruit and grapefruit juice during the study

Exclusion Criteria

  • Currently taking medications that should not be used with statins, such as certain antibiotics and HIV medications.
  • Currently taking medications that should not be used with ezetimibe, like gemfibrozil or cyclosporine.
  • History of severe allergic reactions to the study medications.
  • History of muscle pain with statin use.
  • Have acute liver failure or severe liver disease.
  • Already taking the maximum dose of Vytorin (10/80).
  • Already using a PCSK9 inhibitor.

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