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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00176527
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed hormone-refractory metastatic prostate cancer
* Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease
* Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Estimated life expectancy ≥ 6 months
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin ≥ 8 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
* Bilirubin normal
* AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria:
* AP normal and AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* AP elevated and AST and ALT normal
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No peripheral neuropathy \> grade 1
* No concurrent active infections
* No concurrent major depression or suicidal ideation
* No concurrent medical condition that would preclude study participation
* No known HIV positivity
* Fertile patients must use effective contraception during and for 10 weeks after completion of study therapy
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery or radiotherapy
* No prior chemotherapy, retinoids, or interferon therapy
* More than 4 weeks since prior flutamide
* More than 6 weeks since prior bicalutamide
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00176527
Study Brief:
Protocol Section:
NCT00176527