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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00471718
Eligibility Criteria:
Inclusion Criteria:
* Patients at least 18 years of age.
* Patients must have histologically proven adenocarcinoma of the prostate gland.
* Patients must have metastatic disease (e.g. bone metastases, pelvic mass, nodal, liver or lung metastases), with evidence of radiographic progression (including bone scans observed during last treatment) or serologically -Patients with bone-only metastases (i.e. lacking soft tissue or visceral disease) must have a PSA level \> 10 ng/mls. Patients with soft tissue metastases and/or visceral disease must have either measurable disease OR a PSA level \> 10 ng/ml.
* Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g. LHRH therapy, estrogens, etc.) with evidence of treatment failure and simultaneous documentation of a castrate testosterone level (\< 50 ng/dL) NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy for the duration of this protocol unless this medically contraindicated.
* For patients previously treated with flutamide, nilutamide, or bicalutamide: patients must have discontinued flutamide or nilutamide \> 4 weeks prior to randomization (\> 6 weeks for bicalutamide) with no evidence of an anti-androgen withdrawal response (i.e. no decline in serum PSA and/or no improvement in baseline scans).
* Patients must have received prior therapy with docetaxel alone or in combination with either prednisone or estramustine. This therapy may have been given in a neoadjuvant, adjuvant or metastatic setting
* Patients must not have received radiotherapy \< 3 weeks prior to randomization. If patients have received prior radiotherapy to an evaluable lesion(s), there must be evidence of radiographic progression prior to entry.
* Patients must not have received prior Strontium 89, Samarium 153, or other therapeutic radioisotopes.
* Patients must have recovered from all systemic toxicities due to prior treatment for prostate cancer (does not include incontinence, impotence, etc. secondary to primary therapy)
* The patient must have an ECOG Performance Status of 0-1
* The patient must have adequate hematologic, renal and hepatic function as follows:
1. Hematologic: ANC \> 1200/mm3; hemoglobin \> 9.0 g/dl; platelets \> 100,000/mm3
2. Renal: serum creatinine \< 2.0 mg/dL
3. Hepatic: bilirubin \< 2.5 mg/dL; AST and ALT \< 2.5X upper limit of normal (ULN); \< 5X ULN for patients with hepatic metastases
* Sexually-active patients must use a contraceptive method deemed acceptable by the investigator while in the study and for up to 3 months following completion of therapy.
* The patient or the patient's legally acceptable representative has voluntarily signed and dated an informed consent approved by and Institutional Review Board prior to any study any study specific procedures.
* Patients may be receiving bisphosphonate therapy prior to randomization and continue while receiving protocol therapy, but must not begin treatment with bispohosphonates while receiving protocol therapy. Patients on bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to entry onto study.
* Patients with a history of a prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific malignancy.
Exclusion Criteria:
* No active angina pectoris, uncontrolled hypertension, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction, congestive cardiac failure (New York Heart Association Class 3), or coronary angioplasty/stenting \< 6 months prior to entry.
* No carcinomatous meningitis or brain metastases.
* Any investigational therapy within 4 weeks.
* No serious concurrent medical illness or active infection, which, in the opinion of the investigator, would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.
* Documented history of allergy to sulfa medications.
* Current colchicines treatment
* Greater than Grade 1 CTC neurology category findings (Appendix A).
* Prior treatment with more than 1 prior chemotherapy regimen.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00471718
Study Brief:
Protocol Section:
NCT00471718