Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy:

  • pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen
  • Any pT3a tumor with Gleason score ≥ 4+3
  • pT3b tumor with Gleason score ≥ 7
• Negative lymph nodes at histological examination (N0)
• Patients with a preoperative prostate-specific antigen (PSA) ≥ 10.0 ng/mL should have undergone a lymph node dissection
• Postoperative PSA must be < 0.5 ng/mL
• Considered at high risk for recurrent disease

• No metastatic (M0) disease

  • Negative bone scan

PATIENT CHARACTERISTICS:

• WHO/ECOG performance status 0-1
• Hemoglobin ≥ 11.0 g/dL
• Neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 150,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal
• AST and ALT ≤ 1.5 times ULN
• Alkaline phosphatase < 1.5 times ULN
• No active untreated infectious disease (e.g., tuberculosis or methicillin-resistant Staphylococcus aureus)
• No active gastric ulcer
• No known hypersensitivity to polysorbate 80
• No symptomatic peripheral neuropathy ≥ grade 2
• No myocardial infarction within the past 6 months
• No other unstable cardiovascular disease within the past 6 months
• No other serious illness or medical condition
• No altered psychological or physical state that would preclude study compliance
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues and/or antiandrogens) affecting prostate cancer cells
• No prior radiotherapy to the pelvis
• No prior chemotherapy
• More than 6 months since prior systemic corticosteroids
• No other concurrent anticancer therapy or investigational drugs