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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00943956
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of high-risk, locally advanced prostate cancer meeting ≥ 1 of the following criteria:
* Clinical stage ≥ T3
* Gleason score ≥ 8
* PSA ≥ 20 ng/mL
* Previously untreated disease
* Non-metastatic disease as assessed by bone scan and CT scan of the thorax and abdomen
* Negative pelvic lymph nodes as proven by pathological analysis
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* WBC ≥ 3.5 x 10\^9/L
* ANC ≥ 1.5 x 10\^9/L
* Platelets normal
* Hemoglobin \> 10 g/dL
* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Albumin ≥ 3 g/dL
* Serum transaminases activity ≤ 2.5 x ULN
* Alkaline phosphatase ≤ 2.5 x ULN
* Serum creatinine ≤ 1.5 x ULN
* Covered by national health insurance
* No history of previous malignant disease, except for adequately treated basal cell carcinoma of the skin
* No ≥ grade 3 hypercholesterolemia/hypertriglyceridemia or ≥ grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment, if given)
* No uncontrolled infection
* No dysphagia or intestinal malabsorption
* No other concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease \[unstable angina\], uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
* No history of noncompliance to medical regimens
* No known hypersensitivity to everolimus, sirolimus (rapamycin), or temsirolimus
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 30 days since prior investigational drugs
* More than 10 days since prior and no concurrent treatment with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
80 Years
Study:
NCT00943956
Study Brief:
Protocol Section:
NCT00943956