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:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00572468
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7)
* Radical prostatectomy chosen as primary treatment for prostate cancer
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
* Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy)
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* History of or active liver disease or abnormal results of the baseline liver function test (\> 2 x normal)
* Current use of:
* simvastatin
* lovastatin
* other HMG-CoA inhibitors
* lipid-lowering agents
* Amiodarone
* Cholestyramine
* Cholestyramine and colestipol (bile acid sequestrants)
* Clofibrate and fenofibrate
* Cyclosporine
* CYP3A4 inhibitors
* Danazol
* Diltiazem
* Gemfibrozil
* Niacin ( 1 g/day)
* Verapamil and Warfarin
* Known allergy or sensitivity to ingredients in simvastatin
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT00572468
Study Brief:
Protocol Section:
NCT00572468