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 (Jun 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
Treatments studied
Other
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
Demographics
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 →Frequently asked questions
Is NCT05586360 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, hormone therapy, radiation therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage T2C is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages