RecruitingProstate Cancer
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
Eligible age
18+ yrs
Accepts
Men
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Medical University of South Carolina
You may qualify if…
- ✓ 1. Men with pathologically-confirmed localized prostate cancer determined to be intermediate (stage T2b, or Gleason 7, or PSA 10-20 ng/mL) or high risk (stage T2c, or PSA \>/=20 ng/mL, or Gleason \>/=8) of biochemical recurrence at the time of biopsy
- ✓ 2. Electing to undergo prostatectomy;
- ✓ 3. Ability to provide written informed consent and willing to complete study procedures.
You may not qualify if…
- ✕ 1. Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin);
- ✕ 2. Current use of medications contraindicated for concomitant use with 40mg simvastatin:
- ✕ Gemfibrozil
- ✕ Cyclosporine
- ✕ Danazol
- ✕ CYP3A4 inhibitors: itraconazole; ketoconazole; posaconazole; erythromycin; clarithromycin; telithromycin; HIV protease inhibitors; boceprevir; telaprevir; nefazodone
- ✕ 3. Current use of medications requiring lower dose of simvastatin not already listed as exclusions criteria:
- ✕ Verapamil
Where it's recruiting
Georgia
Atlanta
South Carolina
Charleston
Source: ClinicalTrials.gov · NCT05586360 · last updated 2026-03-04