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RECRUITING
NCT06437574
PHASE2

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

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-07-16

Completion Date

2028-05-31

Last Updated

2026-03-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Vytorin

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.

DRUG

Ezetimibe

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