Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (NCT06437574) | Clinical Trial Compass
RecruitingPhase 2
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
United States140 participantsStarted 2024-07-16
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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
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).
What they're measuring
1
Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes.
Timeframe: 3 to 6 months of cholesterol-lowering intervention
✕. 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.