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Trial Title:
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
NCT ID:
NCT06437574
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Vytorin
Description:
Vytorin is a drug combination (Ezetimibe and Simvastatin) that targets the two primary
sources of cholesterol, absorption in the gut and synthesis in the liver.
Arm group label:
Intensive Lipid Lowering
Intervention type:
Drug
Intervention name:
Ezetimibe
Description:
Ezetimibe is a drug that targets one of the primary sources of cholesterol, absorption in
the gut.
Arm group label:
Intensive Lipid Lowering
Summary:
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.
Criteria for 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 a PCSK9 inhibitor
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Hoang
Phone:
310-423-1542
Email:
Amy.Hoang@cshs.org
Start date:
July 16, 2024
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06437574
