Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437574
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-23
Brief Title:
Intensive Cholesterol-Lowering and CD8 T Cells in Prostate Cancer
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion of MTOR TORC2 in T-Cell Surface Glycoprotein CD8 Alpha Chain CD8 Lymphocytes
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Vytoringroup 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 mgdl Dose adjustment is not allowed for ezetimibe
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA280060 | NIH | None | httpsreporternihgovquickSearchR01CA280060 |