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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT00003633
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria:
* Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart
* Appearance of new lesions on bone scan
* Appearance of new soft-tissue lesions
* Measurable or evaluable disease
* No brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Greater than 3 months
Hematopoietic:
* WBC at least 3,500/mm3
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* Alkaline phosphatase no greater than 5 times ULN
* SGOT and SGPT no greater than 2 times ULN
Renal:
* Creatinine no greater than 2 times ULN
Cardiovascular:
* No history of coagulopathy
* No myocardial infarction in the last 6 months
* No history of cardiovascular accident
* No history of congestive heart failure
Neurological:
* No symptomatic peripheral neuropathy greater than grade 1
* No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures
Pulmonary:
* No history of pulmonary embolus
Other:
* Testosterone no greater than 3.5 nmol/L
* No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease
* No active infection
* No other serious illness or medical condition
* No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists)
Radiotherapy:
* No prior radiotherapy to greater than 30% of bone marrow
* At least 6 weeks since isotope therapy
* At least 4 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Other:
* At least 4 weeks since prior investigational drugs
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00003633
Study Brief:
Protocol Section:
NCT00003633