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RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation
therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such
as docetaxel, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. It is not yet known whether androgen-ablation
therapy is more effective with or without docetaxel in treating metastatic prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and
chemotherapy to see how well they work compared to androgen-ablation therapy alone in
treating patients with metastatic prostate cancer.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed prostate cancer - High-volume metastatic disease meeting any of the following criteria: - Visceral metastases (extranodal) - Bone metastases - At least 4 bone lesions - At least 1 bone lesion must be outside of the vertebral column or pelvis - On androgen-deprivation therapy for < 120 days - Prostate-specific antigen (PSA) level may not have risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0-2 - PS 2 eligible only if decline in PS is due to metastatic prostate cancer - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Bilirubin ≤ upper limit of normal (ULN) - ALT ≤ 2.5 times ULN - Creatinine clearance ≥ 30 mL/min - PT and INR ≤ 1.5 times ULN (unless on therapeutic anticoagulation) - PTT ≤ 1.5 times ULN (unless on therapeutic anticoagulation) - No prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin - Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair - No peripheral neuropathy > grade 1 - No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No active cardiac disease, including the following: - Active angina - Symptomatic congestive heart failure - Myocardial infarction within the past 6 months - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization - Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true: - Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following: - PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy - PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy - Therapy lasted no more than 24 months - Last depot injection must have expired by the 24-month mark - Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation - Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare - No prior chemotherapy in adjuvant or neoadjuvant setting - No prior hormone therapy in the metastatic setting - More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial - Patients can not simultaneously enroll on CALGB 90202 - Concurrent participation in nontherapeutic trials allowed - Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy - No concurrent 5-alpha reductase inhibitors
Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT00309985
Not Accepting Healthy Volunteers