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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00028769
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
* Clinical stage D2 disease as evidenced by one of the following:
* Visceral disease (liver, lung, or other viscera)
* Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull) and appendicular (claviculae, humeri, or femora) skeleton
* No prior or concurrent (treated or untreated) brain metastases
* Patients with clinical evidence of brain metastasis must have a negative brain CT or MRI
* No evidence of untreated spinal cord compression
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active hypercoagulability
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No transient ischemic attacks, stroke, or myocardial infarction within the past 6 months
* No active coronary artery disease requiring antianginal therapy
* No active thrombophlebitis
Pulmonary:
* No history of pulmonary embolus
Other:
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy and recovered
* No concurrent biologic therapy
Chemotherapy:
* No prior cytotoxic chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist and antiandrogen therapy) allowed if administered for a duration of less than 30 days
* Prior neoadjuvant hormonal therapy allowed
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* At least 4 weeks since prior surgery and recovered
Other:
* No concurrent bisphosphonates
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00028769
Study Brief:
Protocol Section:
NCT00028769