NCT05586360RecruitingPhase 2
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 13 Oct 2022
- Start date
- 11 Mar 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Prostate cancer
- NCT number
- NCT05586360
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 11 Mar 2024 to the primary completion date, 1 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin);
- 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
- Statin use in the previous 12 months;
- Prior neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy;
- Diagnosed diabetes or currently taking diabetes medications
- Prior myocardial infarction or stroke
Other illness
- History of non-prostate cancer other than non-melanoma skin cancer in the last 24 months;
Lab values
- 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
- 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);
- History of myopathy or inflammatory muscle disease (\>3x clinical laboratory's upper limit of normal creatine kinase).
Other
- Men with low-density lipoprotein cholesterol \<50mg/dL
- Discontinued statin use because of statin-related adverse event;
- Evidence or suspicion of metastases;
Who the study is looking for
- 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
- Electing to undergo prostatectomy;
- Ability to provide written informed consent and willing to complete study procedures.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
| Hollings Cancer Center at Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.