RecruitingPhase 2NCT06437574

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

Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes


Sponsor

Cedars-Sinai Medical Center

Enrollment

140 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether aggressively lowering cholesterol with a combination drug (Vytorin, which contains simvastatin and ezetimibe) can boost the immune system's ability to fight low-risk prostate cancer in men who are on active surveillance (watchful waiting rather than immediate treatment). **You may be eligible if...** - You have been diagnosed with low or intermediate-risk prostate cancer (PSA ≤ 20, Gleason score 3+3 to 4+3, stage T1c or T2) - You are on active surveillance with a biopsy planned - You have at least one cardiovascular risk factor (e.g., age ≥ 50, high blood pressure, high cholesterol, diabetes, BMI > 25, smoking history, family history of heart disease) - You have not had prior radiation, chemotherapy, or hormonal therapy for prostate cancer - You are able to take a daily oral medication **You may NOT be eligible if...** - You are on medications that interact with statins (such as certain antifungals or antibiotics) - You have a history of severe muscle pain from statin use - You have active liver disease or severe liver failure - You are already on the maximum statin dose or a PCSK9 inhibitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT06437574


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