T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
Medical University of South Carolina
Summary
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.
Description
Prior research has demonstrated a consistently strong inverse association between statin drug use and risk of developing lethal prostate cancer, and a stronger protective effect with a longer duration of use. Further, in men with clinically localized prostate cancer, statins are associated with a reduced risk of progression to metastasis and dying from prostate cancer. For statins to have clinical utility as chemo-preventive and therapeutic (adjuvant) agents, additional characterization of the mechanisms through which statins interact with the tumor microenvironment are needed. Statin drugs ha…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion 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. Exclusion Criteria: 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 wit…
Interventions
- DrugSimvastatin 40mg
Simvastatin 40mg taken orally daily for 8 weeks
Locations (2)
- Emory UniversityAtlanta, Georgia
- Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina