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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00554918
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Histologically or cytologically proven prostate adenocarcinoma
* Multiple sclerotic bone metastases with PSA ≥ 100 ng/mL without histological confirmation
* Radiological evidence of bone metastasis
* Prior hormonal therapy for prostate cancer including ≥ 1 of the following:
* Bilateral orchidectomy
* Medical castration by luteinizing hormone-releasing hormone (LHRH) agonist therapy
* If receiving LHRH agonist therapy alone, this therapy should be continued
* Documented disease progression, defined by one of the following:
* Progressive disease after discontinuing hormone therapy
* Elevated and rising PSA, defined as 2 consecutive increases in PSA documented over a previous reference value
* PSA \> 5ng/mL
* Progression of any unidimensionally or bidimensionally measurable malignant lesion
* At least 1 new lesion identified on bone scan
* No known brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Hemoglobin ≥ 10g/dL
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 1.5 times ULN (unless related to hepatic metastatic disease, where patients may be entered after discussion with one of the clinical advisors)
* Serum bilirubin ≤ 1.5 times ULN
* Physically fit enough to receive trial treatment
* No malignant disease within the past 5 years, other than adequately treated basal cell carcinoma
* No symptomatic peripheral neuropathy ≥ grade 2 (NCI CTC)
* No known hypersensitivity to bisphosphonates
* No condition, in the opinion of the investigator, that may interfere with the safety of the patient or evaluation of the study objectives
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior flutamide, nilutamide, or cyproterone acetate with evidence of disease progression since cessation
* At least 6 weeks since prior bicalutamide with evidence of disease progression since cessation
* At least 4 weeks since prior estramustine and any adverse events must have resolved
* At least 2 months since prior treatment with a bisphosphonate for any reason
* No treatment with any other investigational compound within the past 30 days
* No prior cytotoxic chemotherapy for hormone refractory prostate cancer (HRPC), other than estramustine monotherapy
* No prior radionuclide therapy for HRPC
* No prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation
* No concurrent enrollment in any other investigational clinical trial
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00554918
Study Brief:
Protocol Section:
NCT00554918