Actively Recruiting
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
Led by Medical University of South Carolina · Updated on 2026-03-04
36
Participants Needed
2
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with localized prostate cancer confirmed by pathology, classified as intermediate risk (stage T2b, Gleason 7, or PSA 10-20 ng/mL) or high risk (stage T2c, PSA ≥ 20 ng/mL, or Gleason ≥ 8) at biopsy
- Planning to undergo prostatectomy
- Able to give written informed consent and willing to complete study procedures
You will not qualify if you...
- Current use of statins or non-statin lipid-lowering drugs such as fibrates, bile acid sequestrants, or niacin
- Taking medications contraindicated with 40 mg simvastatin, including gemfibrozil, cyclosporine, danazol, or certain CYP3A4 inhibitors like itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone
- Taking medications requiring a lower dose of simvastatin such as verapamil, diltiazem, amiodarone, ranolazine, or calcium channel blockers (verapamil, diltiazem, amlodipine)
- Low-density lipoprotein cholesterol below 50 mg/dL
- Statin use within the previous 12 months
- Prior discontinuation of statins due to adverse effects
- Evidence or suspicion of cancer metastases
- Previous neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy
- History of non-prostate cancer (except non-melanoma skin cancer) within the last 24 months
- Diagnosed diabetes or current diabetes medication use
- History of heart attack or stroke
- Chronic liver disease such as hepatitis or cirrhosis, or abnormal liver function exceeding 1.5 times the upper limit of normal
- Stage 4 or 5 chronic kidney disease with creatinine clearance or estimated glomerular filtration rate below 30 mL/min
- History of muscle disease or myopathy with elevated creatine kinase levels over 3 times the upper limit of normal
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Trial Site Locations
Total: 2 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
2
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
A
Alan Brisendine
CONTACT
J
Jasmin M Brooks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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