RecruitingPhase 2NCT05586360

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


Sponsor

Medical University of South Carolina

Enrollment

36 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking simvastatin (a cholesterol-lowering medication) before prostate removal surgery can help the immune system better fight prostate cancer. Researchers will measure changes in immune cells (T-regulatory cells) in the prostate tissue removed during surgery. **You may be eligible if...** - You are a man with confirmed prostate cancer at intermediate or high risk of recurrence (based on stage, Gleason grade, or PSA level) - You have chosen to have your prostate surgically removed (prostatectomy) - You are not currently taking any statin or lipid-lowering medications **You may NOT be eligible if...** - You currently take statins, fibrates, niacin, or bile acid sequestrants (cholesterol-lowering drugs) - You take medications that interact unsafely with simvastatin (such as certain antifungals, antibiotics, or HIV drugs) - You have conditions that make simvastatin unsafe for you (liver disease, certain muscle conditions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSimvastatin 40mg

Simvastatin 40mg taken orally daily for 8 weeks


Locations(2)

Emory University

Atlanta, Georgia, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05586360


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