Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06437574
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vytorin — DRUG
    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.
  • Ezetimibe — DRUG
    Ezetimibe is a drug that targets one of the primary sources of cholesterol, absorption in the gut.

Study Details

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.

Key Dates

Start date
Jul 16, 2024
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
May 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Intensive Lipid Lowering
    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.

Primary Outcome Measure

Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes. [ Time Frame: 3 to 6 months of cholesterol-lowering intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Amy Hoang
[email protected]
310-423-1542

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

Related Studies