Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
Recruiting · NCT06437574 · Interventional (participants receive a specific treatment) · Lead sponsor: Cedars-Sinai Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
- First-degree family history of any cardiovascular heart disease
- BMI \> 25
- 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 it is running
1 location listed across 1 US state.
- Cedars-Sinai Medical Center - Los Angeles, California, United States