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

StatusRecruiting
PhasePhase 2
Started2024-07-16
View on ClinicalTrials.gov ↗

Amendment history

2026-03-09
Study Identification, Study Status v6
Re-verified, no change to tracked fields
2025-02-25
Study Status, Eligibility v5
Eligibility criteria+174 characters
[...] mpensated cirrhosis Already on maximum VYTORIN dose (10/80) Already on medication(s) known to interact with Vytorin or Ezetimibe that may prevent protocol-based escalation of cholesterol-lowering therapy from pre-enrollment baseline. Already on a PCSK9 inhibitor
2024-10-04
Study Identification, Study Status, Sponsor/Collaborators, Arms and Interventions v4
InterventionsVytorin (Drug)→Ezetimibe (Drug), Vytorin (Drug)
Collaborators-31 characters
National Cancer Institute (NCI)
2024-07-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-07-01→confirmed 2024-07-16
Study sites0→1
2024-07-11
Study Status, Eligibility v2
Eligibility criteria+2 characters
[...] er defined as: Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml Clinical stage T1c or cT2 Gleason score 3+3 or 3+ [...]
2024-06-04
Study Status, Outcome Measures v1
Primary endpoints1 entry, revised
Pre/Post-change in %percent prostate infiltrating CD8+ T lymphocytes.
2024-05-29
Original filing
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.
Trial Details
NCT Number NCT06437574
Lead Sponsor Cedars-Sinai Medical Center
Conditions Prostate Cancer
Enrollment 140 participants
Start Date 2024-07-16
Primary Completion 2028-02-29 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-11