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

Description

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

Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Charleston

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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
  • * Diltiazem
  • * Amiodarone
  • * Ranolazine
  • * Calcium channel blockers: verapamil; diltiazem; amlodipine
  • 4. Men with low-density lipoprotein cholesterol \<50mg/dL
  • 5. Statin use in the previous 12 months;
  • 6. Discontinued statin use because of statin-related adverse event;
  • 7. Evidence or suspicion of metastases;
  • 8. Prior neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy;
  • 9. History of non-prostate cancer other than non-melanoma skin cancer in the last 24 months;
  • 10. Diagnosed diabetes or currently taking diabetes medications
  • 11. Prior myocardial infarction or stroke
  • 12. Chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (\>1.5x clinical laboratory's upper limit of normal alanine aminotransferase);
  • 13. Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate \< 30 mL/min calculated by Cockgroft-Gault formula);
  • 14. History of myopathy or inflammatory muscle disease (\>3x clinical laboratory's upper limit of normal creatine kinase).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Michael Marrone, PhD, PRINCIPAL_INVESTIGATOR, Public Health Sciences

Study Record Dates

2026-08-01