Phase
Condition
Urologic Cancer
Prostate Disorders
Prostate Cancer, Early, Recurrent
Treatment
Ezetimibe
Vytorin
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for theduration of the study.
At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as:
≥ 50 years of age
Hypertension
Hypercholesterolemia
Diabetes
Current or former smoker
First-degree family history of any cardiovascular heart disease
BMI > 25
On hypertension treatment, statin, and/or aspirin therapy
Patients with clinically localized prostate cancer. That is Low or intermediate riskprostate cancer defined as:
Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml
Clinical stage T1c or cT2
Gleason score 3+3 or 3+4 or 4+3
Patients on AS with plans for surveillance biopsy
No previous treatment for prostate cancer with radiotherapy, chemotherapy, orhormonal therapy
Ability to take oral medication and be willing to adhere to once daily, oral Vytorinor ezetimibe.
Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per daythroughout study duration.
Exclusion
Exclusion Criteria:
Current use of medications contraindicated for use with a statin such as strongCYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin,clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
Current use of medications contraindicated for use with ezetimibe (i.e.,gemfibrozil, cyclosporine, or danazol).
History of allergic or severe reaction to a either study agent.
History of moderate or severe myalgia with statin use.
Acute liver failure or decompensated cirrhosis
Already on maximum VYTORIN dose (10/80)
Already on medication(s) known to interact with Vytorin or Ezetimibe that mayprevent protocol-based escalation of cholesterol-lowering therapy frompre-enrollment baseline.
Already on a PCSK9 inhibitor
Study Design
Connect with a study center
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
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