Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
1400
Trial Sponsor
Clinical Trial Start Date
July 1, 2024
0Primary Completion Date
February 29, 2028
0Study Completion Date
May 31, 2028
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Drug0
Interventional Trial Phase
Phase 20
Official Name
Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes0
Last Updated
May 31, 2024
0Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Other attributes
Intervention Treatment
Vytorin0
Study 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.
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