Medical University of South Carolina
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.
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…
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…
Simvastatin 40mg taken orally daily for 8 weeks
Arctuva estimate
Verify or correct the compensation shown for this listing.