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:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00049257
Eligibility Criteria:
Inclusion Criteria:
* Patients must be informed of investigational nature of the study and written informed consent must be obtained prior to study entry
* Patients \>18 years of age
* Patients with a histologic diagnosis of adenocarcinoma of the prostate
* Patients must have metastatic disease with progression despite androgen ablation. Patients who have not undergone orchiectomy must continue LHRH analogues. For patients receiving LHRH analogues their testosterone level must be \< 50ng/dL
* Patients with bidimensionally measurable disease or bone metastases that is not progressive but who have a rising PSA are eligible
* Patients with an ECOG performance status \<2
* Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the first day of treatment with evidence of progressive disease. Patients must have discontinued bicalutamide at least 6 weeks prior to registration with evidence of progressive disease
* Patients with adequate hematological, renal, and hepatic function as defined by the following required laboratory values:
* While blood cell count: \> 3,000/mm3
* Absolute granulocyte count: \> 1,500/mm3
* Platelets: \> 100,000/mm3
* Hemoglobin: \> 8.5 g/dL
* Total bilirubin: \< 1.5 mg/dL
* Serum creatinine: \< 2.5 mg/dL
* AST or ALT: \< 2.5 x institutional upper limit of normal
* Patients may have received prior radiation therapy, provided at least 4 weeks have elapsed since the conclusion of radiation therapy
Exclusion Criteria:
* Patients with biochemical only progression
* Patients who have received any prior chemotherapy for cancer of the prostate
* Patients who received antiandrogen therapy within 4 weeks prior to the first day of treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to registration after cessation of bicalutamide
* Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy
* Patients who have received Strontium 89 or other radioisotope therapies
* Patients with decreasing PSA levels following antiandrogen withdrawal
* Patients with \> grade 1 peripheral sensory or motor neuropathy
* Patients with known carcinomatous meningitis or brain metastases are excluded
* Patients with past or current histories of neoplasm other than entry diagnosis except for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy treated by surgery or radiation with a disease-free survival longer than 5 years
* Patients who have undergone major surgery \< 3 weeks prior to registration, except for biopsy or placement of a venous access device. Patients must have fully recovered from all effects of any prior surgery
* Patients with histories of serious cardiac disease not adequately controlled: documented myocardial infarction within the last 6 months preceding registration, congestive heart failure, unstable angina, valvular disease with documented ventricular compromise, uncontrolled hypertension, arrhythmia uncontrolled by medication, clinically significant pericardial effusion
* Patients with active serious infections or other serious underlying medical conditions that would otherwise impair their ability to receive protocol treatments
* Patients with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent
* Patients receiving other investigational therapy
* Use of any investigational agent within 30 days of first day of treatment and use of Ketoconazole, hydrocortisone, glucocorticoids, or megace within 30 days of first day of treatment or other concomitant medications
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00049257
Study Brief:
Protocol Section:
NCT00049257