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Vytorin for Prostate Cancer

Phase 2

Recruiting

Led By Hyung Kim, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take oral medication and willingness to adhere to once daily, oral Vytorin or ezetimibe

No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy

Must not have

Acute liver failure or decompensated cirrhosis

Already on maximum VYTORIN dose (10/80)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 to 6 months of cholesterol-lowering intervention

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test if intensive cholesterol-lowering therapy can affect the immune system in prostate cancer patients. Patients will be given either Vytorin or Ezetimibe to lower their cholesterol levels. The

Who is the study for?

This trial is for men over 50 with prostate cancer who are being closely monitored (active surveillance) and have a planned biopsy in the next 3-6 months. Participants should be willing to follow study procedures, may have conditions like hypertension, high cholesterol, diabetes, or a family history of heart disease, and could be current/former smokers with BMI >25.

What is being tested?

The trial is testing Vytorin®, a combination of ezetimibe and simvastatin that lowers 'bad' LDL cholesterol. It's believed this intensive cholesterol-lowering might help the immune system fight cancer. Patients will start on doses based on their current statin use and LDL levels, aiming to get LDL under 70 mg/dl.

What are the potential side effects?

Vytorin® can cause muscle pain or weakness, liver problems (indicated by yellowing skin/eyes), digestive issues like diarrhea or indigestion, headache, feelings of tiredness, cold-like symptoms such as runny nose or sneezing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take pills and will follow a daily medication routine.

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I have not had radiotherapy, chemotherapy, or hormonal therapy for prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver problems.

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I am currently taking the highest dose of VYTORIN.

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I am not taking gemfibrozil, cyclosporine, or danazol.

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I have experienced severe muscle pain from statin use.

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I am currently taking a PCSK9 inhibitor.

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I am not taking any medications that cannot be used with statins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 to 6 months of cholesterol-lowering intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 to 6 months of cholesterol-lowering intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 6 months of cholesterol-lowering intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intensive Lipid LoweringExperimental Treatment2 Interventions

Single arm with dual agents (ezetimibe and simvastatin) or single agent (ezetimibe). These agents target the two primary sources of cholesterol, absorption in the gut (ezetimibe) and synthesis in the liver (simvastatin). The dual agents are available in a single pill that is FDA approved and sold under the trade name, Vytorin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ezetimibe

2009

Completed Phase 4

~6470

Vytorin

2011

Completed Phase 4

~110