Cholesterol-Lowering Drugs and Immune Cells in Prostate Cancer
This study is looking at whether intensive cholesterol-lowering treatments, Vytorin (a combination of Ezetimibe and Simvastatin) or Ezetimibe alone, can affect the immune system in men with prostate cancer. Specifically, researchers want to see if these drugs change the number of CD8+ T lymphocytes (a type of immune cell that can fight cancer) in the prostate. You might be eligible if you are an adult man with prostate cancer who is on active surveillance and has at least one risk factor for heart disease, such as being over 50, having high blood pressure, or diabetes. The main goal is to measure the change in these immune cells after 3 to 6 months of taking the cholesterol-lowering medication.
- Study design
- This is an open-label, single-arm study, meaning all 140 participants will receive one of the study treatments, and everyone will know which treatment they are getting. It is a Phase II trial.
- What's involved
- Participants will take cholesterol-lowering medication for 3 to 6 months and will undergo a planned surveillance biopsy during this time.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurement of immune cells is taken after 3 to 6 months of cholesterol-lowering intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Hyung Kim, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
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What this trial measures
- Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes.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.