Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05586360
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05586360
Study Brief:
Protocol Section:
NCT05586360