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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT00003400
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic hormone refractory adenocarcinoma of the prostate that is progressive on hormone based therapy, as demonstrated by: New metastatic lesion Consecutive series of increasing PSA levels following hormonal therapy No CNS disease
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (unless due to bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4 million/kg Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FVC, FEV1, and corrected DLCO at least 50% of predicted (high resolution CT scan of chest and P02 at least 70 if unable to complete PFTs) Other: No active infection requiring intravenous antibiotics Not HIV positive
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one course of cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00003400
Study Brief:
Protocol Section:
NCT00003400