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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00664456
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed prostate cancer
* Previously untreated disease
* Intermediate-risk disease, as defined by the following:
* Clinical stage \< T2c
* Prostate-specific antigen (PSA) ≤ 20 ng/mL
* Gleason score \< 8
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Leukocyte count ≥ 3,000/uL
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/uL
* Serum creatinine ≤ 2.0 mg/dL
* ALT and AST ≤ 100 IU/L
* No other cancer requiring treatment
* No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
* No severe psychiatric disorders, including schizophrenia or dementia
* No poorly controlled diabetes
* Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator
PRIOR CONCURRENT THERAPY:
* No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
* No prior surgery for prostate cancer
* No concurrent steroid drugs (except for ointment)
* No other concurrent antiandrogen therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00664456
Study Brief:
Protocol Section:
NCT00664456