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NCT06437574 · ClinicalTrials.gov registry record · Phase 2
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT06437574: Recruiting Phase 2 study of Prostate Cancer, sponsored by Cedars-Sinai Medical Center.
NCT06437574 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 140 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06437574, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Our primary hypothesis is that maximum cholesterol lowering will increase CD8+ memory T cells and increase CD8+ T cell infiltration into prostate tissue. Change in CD8+ T cells in the prostate from baseline to 3 to 6 months is the primary endpoint.
Conditions Studied
Interventions
- DRUG Vytorin
- DRUG Ezetimibe
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2024-07-16 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
What NCT06437574 shows while recruiting
NCT06437574 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Vytorin is the first listed.
NCT06437574 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06437574 about?
NCT06437574 is a clinical study titled "Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer". 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 m...
What is the current status of trial NCT06437574?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2024-07-16. Estimated completion is 2028-05-31.
What conditions does trial NCT06437574 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06437574?
The interventions under investigation include: Vytorin (DRUG), Ezetimibe (DRUG).
Who is sponsoring clinical trial NCT06437574?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06437574 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06437574's enrollment target sits among peer trials
140 279th of 735 higher than 456 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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