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Simvastatin for Prostate Cancer Immune Response

This study is looking at whether Simvastatin 40mg, a common cholesterol-lowering drug, can improve the body's immune response against prostate cancer. Researchers want to see if taking Simvastatin daily for 8 weeks before prostate surgery can reduce the immunosuppressive (immune-suppressing) environment within the prostate tumor. This could potentially help the body fight the cancer better. You may be able to join if you are a man aged 18 or older with localized prostate cancer that is considered intermediate or high risk, and you are planning to have a prostatectomy (surgery to remove the prostate). The main goal is to measure changes in a specific immune cell function (YAP-mediated T-reg dysfunction) in the prostate tissue after 8 weeks. The current status of this study is unclear.

Study design
This is an interventional study where half the participants will receive Simvastatin 40mg daily for 8 weeks, and the other half will receive standard care. It plans to enroll 36 men.
What's involved
If you participate, you would take Simvastatin 40mg orally daily for 8 weeks before your prostatectomy. You would also need to provide written informed consent and complete study procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 8 weeks, which is when the intervention period ends.

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NCT05586360

T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical University of South Carolina
~36 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Simvastatin 40mg

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intra-prostatic YAP-mediated T-reg dysfunction in total tissue area
Measured over 8 weeks

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 2 states
Georgia1
South Carolina1

Study leadership

  • Michael Marrone, PhD · PRINCIPAL_INVESTIGATOR · Public Health Sciences

Who to contact

Alan Brisendine
[email protected]
843-792-9007
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Gemfibrozil
Cyclosporine
Danazol
CYP3A4 inhibitors: itraconazole; ketoconazole; posaconazole; erythromycin; clarithromycin; telithromycin; HIV protease inhibitors; boceprevir; telaprevir; nefazodone
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).

What this trial measures

  • Intra-prostatic YAP-mediated T-reg dysfunction in total tissue area8 weeks

    Number of men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy that have greater intra-prostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group. Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis.