NCT06437574 · Cedars-Sinai Medical Center
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
What this study is about
To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an where both patients and doctors know the treatment given, single-treatment group$1 phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months.
View original scientific description
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.
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.
Primary outcome measures
Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes.
Time frame: 3 to 6 months of cholesterol-lowering intervention
Our primary hypothesis is that maximum cholesterol lowering will increase CD8+ memory T cells and increase CD8+ T cell infiltration into prostate tissue. Change in CD8+ T cells in the prostate from baseline to 3 to 6 months is the primary endpoint.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Current or former smoker
- First-degree family history of any cardiovascular heart disease
- On hypertension treatment, statin, and/or aspirin therapy
- Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as:
- Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml
- Clinical stage T1c or cT2
- Gleason score 3+3 or 3+4 or 4+3
- Patients on AS with plans for surveillance biopsy
- No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
- Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe.
- Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration.
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).
- 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.
- Already on a PCSK9 inhibitor
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations