Investigating the effects of simvastatin on prostate cancer treatment
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
This study is testing if taking simvastatin for eight weeks before prostate surgery can help boost the immune response in men recently diagnosed with localized prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT05586360 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of simvastatin on the immune response in men recently diagnosed with localized prostate cancer who are planning to undergo prostatectomy. Participants will be randomly assigned to receive either simvastatin or standard care for eight weeks prior to surgery. The research aims to understand how simvastatin may alter the immunosuppressive environment within the prostate, potentially enhancing anti-tumor immune responses. The study focuses on the role of YAP-mediated T-reg dysfunction in this process.
Who should consider this trial
Good fit: Ideal candidates are men with pathologically-confirmed localized prostate cancer classified as intermediate or high risk who are electing to undergo prostatectomy.
Not a fit: Patients currently using statins or certain contraindicated medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to enhance immune response against prostate cancer, potentially improving patient outcomes.
How similar studies have performed: Previous studies have indicated a protective effect of statins against lethal prostate cancer, suggesting that this approach may build on established findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 with 40mg simvastatin: * Gemfibrozil * Cyclosporine * Danazol * CYP3A4 inhibitors: itraconazole; ketoconazole; posaconazole; erythromycin; clarithromycin; telithromycin; HIV protease inhibitors; boceprevir; telaprevir; nefazodone 3. Current use of medications requiring lower dose of simvastatin not already listed as exclusions criteria: * Verapamil * Diltiazem * Amiodarone * Ranolazine * Calcium channel blockers: verapamil; diltiazem; amlodipine 4. Men with low-density lipoprotein cholesterol \<50mg/dL 5. Statin use in the previous 12 months; 6. Discontinued statin use because of statin-related adverse event; 7. Evidence or suspicion of metastases; 8. Prior neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy; 9. History of non-prostate cancer other than non-melanoma skin cancer in the last 24 months; 10. Diagnosed diabetes or currently taking diabetes medications 11. Prior myocardial infarction or stroke 12. Chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (\>1.5x clinical laboratory's upper limit of normal alanine aminotransferase); 13. Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate \< 30 mL/min calculated by Cockgroft-Gault formula); 14. History of myopathy or inflammatory muscle disease (\>3x clinical laboratory's upper limit of normal creatine kinase).
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
- Hollings Cancer Center at Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Michael Marrone, PhD — Public Health Sciences
- Study coordinator: Alan Brisendine
- Email: brisend@musc.edu
- Phone: 843-792-9007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.