T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
About This Trial
- This study is exploring whether a common cholesterol-lowering medication, simvastatin, can boost the body's immune system to help fight prostate cancer.
- It is open to men with newly diagnosed, intermediate-to-high-risk prostate cancer who are already scheduled to have surgery to remove their prostate.
- Half of the participants will take the daily medication for eight weeks before their surgery, while the other half will receive standard care without the pill.
- Before considering this study, you should know that you cannot join if you currently take cholesterol drugs or have certain health conditions like diabetes, heart disease, or liver problems.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is exploring whether a common cholesterol-lowering medication, simvastatin, can boost the body's immune system to help fight prostate cancer.
Study Details
- Start Date: March 11, 2024
- Lead Sponsor: Medical University of South Carolina
Full Eligibility Criteria
Inclusion Criteria
- 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
- Electing to undergo prostatectomy;
- Ability to provide written informed consent and willing to complete study procedures.
Exclusion Criteria
- Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin);
- 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
- Current use of medications requiring lower dose of simvastatin not already listed as exclusions criteria:
- Verapamil
- Diltiazem
- Amiodarone
- Ranolazine
- Calcium channel blockers: verapamil; diltiazem; amlodipine
- Men with low-density lipoprotein cholesterol 1.5x clinical laboratory's upper limit of normal alanine aminotransferase);
- Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate 3x clinical laboratory's upper limit of normal creatine kinase).
Treatments
- Drug: Simvastatin 40mg