Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

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.

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes

Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Hyung Kim, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2028-05-31