• Disease-free survival [ Designated as safety issue: No ]
  

• Overall survival [ Designated as safety issue: No ]
  
• Time to biochemical disease progression [ Designated as safety issue: No ]
  
• Time to local disease progression [ Designated as safety issue: No ]
  
• Time to distant disease progression [ Designated as safety issue: No ]
  
• Time to next anti-cancer therapy [ Designated as safety issue: No ]
  
• Progression-free survival [ Designated as safety issue: No ]
  
• Degree of prostate-specific antigen (PSA) suppression prior to radiotherapy [ Designated as safety issue: No ]
  
• Quality of life [ Designated as safety issue: No ]
  
• Adverse events [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• To compare disease-free survival rates in patients with high-risk localized adenocarcinoma of the prostate treated with androgen suppression therapy and radiotherapy with vs without docetaxel.

Secondary

• To compare overall survival.
• To compare time to biochemical disease progression.
• To compare time to local disease progression.
• To compare time to distant disease progression.
• To compare time to next anticancer therapy.
• To compare progression-free survival.
• To compare degree of prostate-specific antigen (PSA) suppression prior to radiotherapy.
• To compare quality of life (QOL) using EORTC QLQ C30 and EORTC QLQ PR25 questionnaires and a trial-specific checklist.
• To compare the nature, severity, and frequency of adverse events.

OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 7 vs ≥ 8), baseline prostate-specific antigen (PSA) (> 20 ng/mL vs ≤ 20 ng/mL), and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive androgen suppression therapy comprising oral flutamide three times daily or oral bicalutamide once daily for 4 weeks AND leuprolide subcutaneously (SC) or intramuscularly every 1-6 months, buserelin SC every 2 or 3 months, or goserelin SC every 1 or 3 months for 3 years. Patients also receive docetaxel IV over 60 minutes on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses. Beginning at least 4 weeks after completion of chemotherapy, patients undergo pelvic radiotherapy once daily 5 days a week for up to 8 weeks.
• Arm II: Patients receive androgen suppression therapy and undergo pelvic radiotherapy as in arm I.

Patients complete quality of life questionnaires at baseline, periodically during treatment, and then every 6 months for 5 years.

After completion of study treatment, patients are followed at 3 and 6 months, every 6 months for 5 years, and then annually thereafter.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

  • Localized (N0, M0) disease
  • No small cell or transitional cell carcinoma in the biopsy specimen

• Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features:

  • T stage ≥ 3a
  • Gleason score ≥ 8
  • Baseline prostate-specific antigen (PSA) > 20 ng/mL
• Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical oncologist

• Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and pelvis

  • Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically negative by either needle aspirate or lymph node dissection
• No metastases by chest x-ray and bone scan

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• AST and/or ALT ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Total bilirubin normal
• Serum creatinine ≤ 1.5 times ULN
• Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of other malignancies, except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor with no evidence of disease for > 5 years
• No serious non-malignant disease resulting in a life expectancy of < 10 years
• No known hypersensitivity to any study medications
• No existing peripheral neuropathy ≥ grade 2
• No bilateral hip replacement prostheses
• No contraindication to pelvic radiotherapy including, but not limited to, inflammatory bowel disease or severe bladder irritability
• No medical condition that would contraindicate the study treatment regimen, including severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension
• No other serious illness or psychiatric or medical condition that would preclude management of the patient according to the study, including active uncontrolled infection or significant cardiac dysfunction

PRIOR CONCURRENT THERAPY:

• Prior androgen suppression therapy allowed provided it was initiated no more than 4 weeks prior to study entry
• At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for benign prostatic hypertrophy
• No prior cytotoxic anticancer therapy
• No prior chemotherapy for carcinoma of the prostate
• No prior surgical treatment for carcinoma of the prostate, except transurethral resection or bilateral orchiectomy
• No prior pelvic radiotherapy
• No concurrent nilutamide
• No other concurrent investigational drugs
• No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or radiotherapy)