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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether strong cholesterol lowering with Vytorin or ezetimibe helps immune cells fight prostate cancer. It is for people whose prostate cancer is being closely watched without treatment and who have a planned biopsy, or tissue sample test, in 3–6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a consent form, agree to follow study steps, and be available for the whole study.
  • Have at least one heart disease risk factor: age 50 or older, high blood pressure, high cholesterol, diabetes, current or past smoking, a parent, sibling, or child with heart disease, BMI over 25, or use of blood pressure medicine, a statin, or aspirin.
  • Have prostate cancer that has not spread beyond the prostate: PSA blood test level of 20 ng/ml or less, stage T1c or T2, and Gleason score 3+3, 3+4, or 4+3. Stage and Gleason score describe the cancer's extent and how it looks under a microscope.
  • Be on active surveillance, meaning the cancer is closely watched without treatment, with a planned biopsy.
  • Have had no radiation, chemotherapy, or hormone treatment for prostate cancer.
  • Be able and willing to take Vytorin or ezetimibe by mouth once a day.
  • Agree to avoid large amounts of grapefruit or grapefruit juice—one quart or more per day—during the study.

Who can't join

  • Take medicines that cannot be used with statins, including certain medicines for fungal infections, antibiotics, HIV medicines, or nefazodone.
  • Take gemfibrozil, cyclosporine, or danazol, which cannot be used with ezetimibe.
  • Have had an allergic or severe reaction to either study medicine.
  • Have had moderate or severe muscle pain while taking a statin.
  • Have sudden liver failure or advanced liver scarring that keeps the liver from working properly.
  • Already take the highest Vytorin dose, 10/80.
  • Take medicines that interact with Vytorin or ezetimibe and may prevent raising cholesterol-lowering treatment as the study requires.
  • Already take a PCSK9 inhibitor, a type of cholesterol-lowering medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 medication(s) known to interact with Vytorin or Ezetimibe that may prevent protocol-based escalation of cholesterol-lowering therapy from pre-enrollment baseline. 8. Already on a PCSK9 inhibitor

Study sites (1)

CA