Actively Recruiting
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
Led by Cedars-Sinai Medical Center · Updated on 2026-03-11
140
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to follow all study procedures and available for the study duration
- At least one atherosclerotic cardiovascular disease risk factor such as age 50 or older, hypertension, hypercholesterolemia, diabetes, smoking history, family history of cardiovascular disease, BMI over 25, or on hypertension/statin/aspirin therapy
- Clinically localized low or intermediate risk prostate cancer with PSA 3 20.0 ng/ml, clinical stage T1c or cT2, and Gleason score 3+3, 3+4, or 4+3
- On active surveillance with plans for a surveillance biopsy
- No prior prostate cancer treatment with radiotherapy, chemotherapy, or hormonal therapy
- Able and willing to take daily oral Vytorin or ezetimibe
- Agree to limit grapefruit and grapefruit juice intake to less than one quart per day throughout the study
You will not qualify if you...
- Currently taking medications contraindicated with statins such as strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, erythromycin, HIV protease inhibitors)
- Currently taking medications contraindicated with ezetimibe such as gemfibrozil, cyclosporine, or danazol
- History of allergic or severe reaction to study drugs
- History of moderate or severe muscle pain with statin use
- Acute liver failure or decompensated cirrhosis
- Already on maximum Vytorin dose (10/80)
- Taking medications that interact with Vytorin or ezetimibe that prevent dose escalation
- Already using a PCSK9 inhibitor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
A
Amy Hoang
CONTACT
L
Laura Sarmiento
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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