S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

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)