Investigating the effects of simvastatin on prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hollings Cancer Center at Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Michael Marrone, PhD — Public Health Sciences
• Study coordinator: Alan Brisendine
• Email: brisend@musc.edu
• Phone: 843-792-9007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.