Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
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:
🦠 Prostate Cancer
🗓️ Study Start (Actual) 16 July 2024
🗓️ Primary Completion (Estimated) 29 February 2028
✅ Study Completion (Estimated) 31 May 2028
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Provision of signed and dated informed consent form.
    • 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
    • 3. At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as:
    • 1. ≥ 50 years of age
    • 2. Hypertension
    • 3. Hypercholesterolemia
    • 4. Diabetes
    • 5. Current or former smoker
    • 6. First-degree family history of any cardiovascular heart disease
    • 7. BMI \> 25
    • 8. On hypertension treatment, statin, and/or aspirin therapy
    • 4. Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as:
    • 1. Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml
    • 2. Clinical stage T1c or cT2
    • 3. Gleason score 3+3 or 3+4 or 4+3
    • 5. Patients on AS with plans for surveillance biopsy
    • 6. No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
    • 7. Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe.
    • 8. Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration.

    Exclusion Criteria:

    • 1. 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).
    • 2. Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol).
    • 3. History of allergic or severe reaction to a either study agent.
    • 4. History of moderate or severe myalgia with statin use.
    • 5. Acute liver failure or decompensated cirrhosis
    • 6. Already on maximum VYTORIN dose (10/80)
    • 7. Already on a PCSK9 inhibitor
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 May 2024
  • First Submitted that Met QC Criteria 29 May 2024
  • First Posted 31 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024