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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00134056
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Stage IV disease (any T, any N, M1b)
* Evidence of bone metastases by bone scan or MRI
* Measurable or nonmeasurable disease
* Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease
* Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:
* Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels\* taken ≥ 1 week apart
* PSA ≥ 5 ng/mL NOTE: \*If the third confirmatory PSA level is \< the second level, the patient is considered eligible provided a fourth PSA level is \> the second level
* Progression of measurable disease
* Progression of nonmeasurable disease by bone scan
* Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone \[LHRH\] agonist \[e.g., leuprolide or goserelin\] or LHRH antagonist therapy) castration
* Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment
* Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease
* No symptomatic pleural effusion
* No third space fluid accumulation (e.g., ascites)
* No prior or concurrent brain metastases
* Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-3\* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Fertile patients must use effective contraception
* Able to take oral medication without crushing, dissolving, or chewing tablets
* No major infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission
* No symptomatic sensory neuropathy ≥ grade 2
* No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No other significant, active medical illness that would preclude study treatment or survival
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 1 prior systemic vaccine or biologic therapy
* At least 4 weeks since prior vaccine or biologic therapy and recovered
* No concurrent biological response modifiers
* No concurrent prophylactic colony-stimulating factors
Chemotherapy
* More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen
* No prior cytotoxic chemotherapy for metastatic prostate cancer
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression
* At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression
* Prior or concurrent megestrol for treatment of hot flashes allowed
* No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy
Radiotherapy
* See Disease Characteristics
* Prior samarium allowed
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to ≥ 30% of the bone marrow
* No prior strontium
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* At least 3 weeks since prior surgery and recovered
Other
* More than 4 weeks since prior investigational drugs
* Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression
* No initiation of bisphosphonates during the first 12 weeks of study treatment
* No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum \[St. John's wort\])
* Concurrent daily vitamins and calcium supplements allowed
* At least 14 days since prior and no concurrent administration of any of the following:
* Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine)
* Antifungals (e.g., itraconazole, ketoconazole, fluconazole \[doses \> 200 mg/day\], and voriconazole)
* Antidepressants (e.g., nefazodone and fluvoxamine)
* Calcium channel blockers (e.g., verapamil, diltiazem)
* Miscellaneous (e.g., amiodarone \[no use within 6 months prior to study entry\], grapefruit juice, bitter orange, or modafinil)
* Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine)
* Antibiotics (e.g., rifampin, rifabutin, and rifapentine)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00134056
Study Brief:
Protocol Section:
NCT00134056