Clinical Trial

T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer

Recruiting Phase 2
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Summary
This study will evaluate whether simvastatin reduces intraprostatic immunosuppressive microenvironment through YAP-mediated T-reg dysfunction, and increases intraprostatic anti-tumor immune response in men recently diagnosed with localized prostate cancer electing to receive prostatectomy for their care. Half the men will be randomized to receive statins for 8 weeks prior to their surgery, while the other half will receive standard of care.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2022-10-17; most recent amendment 2026-03-02.
Status change: Not Yet Recruiting → Recruiting 2022-11-30
Trial Details
NCT Number NCT05586360
Lead Sponsor Medical University of South Carolina
Conditions Prostate Cancer
Enrollment 36 participants
Start Date 2024-03-11
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-04