Study on How Statins May Help Treat Prostate Cancer
Sponsor: Medical University of South Carolina
ClinicalTrials ID:NCT05586360
This clinical trial is exploring whether the cholesterol-lowering drug simvastatin can improve the immune response against prostate cancer in men who are planning to have surgery to remove their prostate.
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Program Overview
The study aims to find out if taking simvastatin, a common cholesterol-lowering medication, can change the immune environment in the prostate and help fight cancer in men recently diagnosed with localized prostate cancer. Participants will be divided into two groups: one group will take simvastatin for eight weeks before their surgery, while the other group will receive standard care without the medication.
Description
Previous research suggests that statins, like simvastatin, may lower the risk of developing serious prostate cancer and slow its progression. This study will investigate how simvastatin affects the immune system's ability to fight prostate cancer. Simvastatin is known to interfere with certain proteins that help cancer cells evade the immune system. The trial will involve 52 men who have been newly diagnosed with localized prostate cancer and are scheduled for prostate surgery. Participants will be randomly assigned to either take simvastatin or receive standard care without the drug. The study will measure changes in cholesterol and inflammation markers, as well as immune cell activity in the prostate, to understand how simvastatin might help the body fight cancer.
Eligibility Criteria
Inclusion Criteria
- Men diagnosed with localized prostate cancer that is considered intermediate or high risk based on specific medical criteria.
- Planning to undergo surgery to remove the prostate.
- Able to provide written consent and willing to participate in study procedures.
Exclusion Criteria
- Currently taking statins or other cholesterol-lowering medications.
- Taking medications that should not be combined with simvastatin, such as certain antibiotics and antifungal drugs.
- Have very low cholesterol levels.
- Have used statins in the past year or stopped due to side effects.
- Have evidence or suspicion of cancer spread beyond the prostate.
- Have received certain cancer treatments before.
- Have had other cancers in the past two years, except for some skin cancers.
- Have diabetes or are taking diabetes medications.
- Have had a heart attack or stroke.
- Have liver or kidney disease, or abnormal liver function tests.
- Have a history of muscle diseases.
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