drugset / Trial / NCT05586360

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

NCT05586360

Phase 2 Recruiting 36 enrolled Medical University of South Carolina
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-11
Primary completion
2027-03-01
Completion
2027-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 40 mg Oral

Indications