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 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT00118066
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed high-grade prostatic intraepithelial neoplasia
* Diagnosed within the past 6 months
* No evidence of prostate cancer within the past 6 months
* No evidence of palpable nodules on digital rectal exam
* Prostate specific antigen ≤ 10 ng/mL within the past 3 months
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT and SGPT ≤ 1.5 times upper limit of normal
Renal
* No uncontrolled renal failure
* No cancer-related hypercalcemia or kidney stones within the past 5 years
Cardiovascular
* No uncontrolled coronary artery disease
* No uncontrolled congestive heart failure
Other
* Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer
* No known HIV positivity
* No active infection
* No major depression or suicidal ideation
* No other condition that would preclude study compliance
* No other uncontrolled medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for any malignancy
Endocrine therapy
* At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor
* No concurrent corticosteroids
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 2 weeks since prior phenytoin or phenobarbital
* At least 2 weeks since prior ketoconazole
* No concurrent administration of any of the following:
* Magnesium-containing antacids
* Thiazide diuretics
* Calcium supplements
* Digoxin
* Herbal supplements
* Pharmacological doses of cholecalciferol (vitamin D) or its derivatives
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00118066
Study Brief:
Protocol Section:
NCT00118066