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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00006002
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy
* Progressive disease defined by 1 of the following criteria:
* New bone scan lesions
* New or progressive radiologic lesions
* Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL
* Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following:
* Continued treatment with an LHRH agonist or prior orchiectomy
* Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide)
* Trial of antiandrogen withdrawal at least 4 weeks prior to study
* CNS metastasis allowed if:
* Previously treated
* Neurologically stable
* Oral or intravenous steroids or anticonvulsants not required
* Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease
* Negative brain scan required if neurologic signs or symptoms suggestive of CNS metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No uncompensated coronary artery disease
* No history of myocardial infarction or severe unstable angina within the past 6 months
* No severe peripheral vascular disease associated with diabetes mellitus
* No deep venous or arterial thrombosis within the past 3 months
Pulmonary:
* No pulmonary embolism within the past 3 months
Other:
* Not pregnant
* Fertile patients must use effective contraception
* No significant uncontrolled underlying medical or psychiatric illness
* No serious active infection
* No other prior or concurrent malignancy except nonmelanoma skin cancer unless completed therapy and considered to be at less than 30% risk of relapse
* No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior systemic chemotherapy
* No other concurrent chemotherapy
* No other concurrent investigational antineoplastic drugs
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 4 weeks since prior major surgery
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00006002
Study Brief:
Protocol Section:
NCT00006002