OncoMatch/Clinical Trials/NCT05586360
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
Is NCT05586360 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Simvastatin 40mg for prostate cancer.
Treatment: Simvastatin 40mg — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage T2C
intermediate (stage T2b, or Gleason 7, or PSA 10-20 ng/mL) or high risk (stage T2c, or PSA 3E/=20 ng/mL, or Gleason 3E/=8) of biochemical recurrence at the time of biopsy
Prior therapy
Cannot have received: chemotherapy
Prior neoadjuvant or adjuvant chemotherapy
Cannot have received: hormone therapy
Prior neoadjuvant or adjuvant hormone therapy
Cannot have received: radiation therapy
Prior neoadjuvant or adjuvant radiation therapy
Lab requirements
Kidney function
No stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate < 30 mL/min calculated by Cockgroft-Gault formula)
Liver function
No chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (>1.5x clinical laboratory's upper limit of normal alanine aminotransferase)
Chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (>1.5x clinical laboratory's upper limit of normal alanine aminotransferase); Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate < 30 mL/min calculated by Cockgroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University · Atlanta, Georgia
- Hollings Cancer Center at Medical University of South Carolina · Charleston, South Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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