Statin trial aims to boost immune system against prostate cancer
NCT ID NCT05586360
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether taking simvastatin, a common cholesterol drug, for 8 weeks before prostate surgery can improve the immune system's ability to fight prostate cancer. Half of the 36 men with localized prostate cancer will receive the drug, while the other half will receive standard care. The study looks at changes in immune cells within the prostate to see if the drug reduces cancer-friendly immune activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simvastatin 40mg
- What this could lead to
- If it works, this could point toward a way to use a common cholesterol drug to help the immune system fight prostate cancer.
- What could go wrong
- This is a small, early-phase trial with only 36 men, so results may not apply to everyone. The drug may not change immune activity as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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Hollings Cancer Center at Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains