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Back|NCT05586360Recruiting
Official Title

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

Phase
Phase 2
Sponsor
Medical University of South Carolina
Enrollment
36
Timeline
Mar 2024 → Aug 2026
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.

Eligibility Criteria

Inclusion Criteria

  • 1Men 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
  • 2Electing to undergo prostatectomy;
  • 3Ability to provide written informed consent and willing to complete study procedures.

Exclusion Criteria

  • 1Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin);
  • 2Current use of medications contraindicated for concomitant use with 40mg simvastatin:
  • 3Gemfibrozil
  • 4Cyclosporine
  • 5Danazol
  • 6CYP3A4 inhibitors: itraconazole; ketoconazole; posaconazole; erythromycin; clarithromycin; telithromycin; HIV protease inhibitors; boceprevir; telaprevir; nefazodone
  • 7Current use of medications requiring lower dose of simvastatin not already listed as exclusions criteria:
  • 8Verapamil
  • 9Diltiazem
  • 10Amiodarone
  • 11Ranolazine
  • 12Calcium channel blockers: verapamil; diltiazem; amlodipine
  • 13Men with low-density lipoprotein cholesterol \<50mg/dL
  • 14Statin use in the previous 12 months;
  • 15Discontinued statin use because of statin-related adverse event;
  • 16Evidence or suspicion of metastases;
  • 17Prior neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy;
  • 18History of non-prostate cancer other than non-melanoma skin cancer in the last 24 months;
  • 19Diagnosed diabetes or currently taking diabetes medications
  • 20Prior myocardial infarction or stroke
  • 21Chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (\>1.5x clinical laboratory's upper limit of normal alanine aminotransferase);
  • 22Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate \< 30 mL/min calculated by Cockgroft-Gault formula);
  • 23History of myopathy or inflammatory muscle disease (\>3x clinical laboratory's upper limit of normal creatine kinase).

Locations

2 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

John Pattaras, MD

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina 29425

Recruiting

Michael Marrone, PhD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →