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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00003367
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with either: Two increases in prostate-specific antigen (PSA) levels with a minimal 30% increase in range of values following either prostate surgery (prostatectomy) or radiation therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times upper limit of normal (ULN) Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 40 mL/min Cardiovascular: No significant heart disease (New York Heart Association class III or IV) Pulmonary: No severe debilitating pulmonary disease Other: No narcotic dependent pain No extreme dietary patterns (such as a macrobiotic diet) No baseline diet having fewer than 25% calories from fat No history of second malignancy within past 5 years except nonmelanomatous skin cancer No insulin-dependent diabetes No infection requiring antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 4 weeks since hormone therapy Radiotherapy: At least 4 weeks since radiotherapy Surgery: Prior prostatectomy allowed Other: Recovered from toxic effects of any prior therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00003367
Study Brief:
Protocol Section:
NCT00003367