Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

• Survival rate, in terms of clinical and biological remission at 8 years [ Designated as safety issue: No ]
  
• Prostate-specific antigen level at 3 months [ Designated as safety issue: No ]
  
• Cancer progression as measured by ultrasound [ Designated as safety issue: No ]
  
• Survival without clinical remission [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  
• Quality of life [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the 8-year survival rate, in terms of clinical and biological remission, of patients with locally advanced prostate cancer or with a high risk of relapse treated with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or without docetaxel and estramustine given before local radiotherapy or prostatectomy.
• Compare the prostate-specific antigen level at 3 months in patients treated with these regimens.
• Compare cancer progression by ultrasound in patients treated with these regimens.
• Compare survival without clinical remission of patients treated with these regimens.
• Compare the overall survival of patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs N1 or N2). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily. Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5. Treatment repeats every 21 days for a total of 4 courses. Patients also receive luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3 months.
• Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning approximately 21 days after chemotherapy is completed, patients with N0 disease undergo radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or N2 disease undergo radiotherapy or no further local treatment.

Hormonal therapy continues in both arms for 3 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 3 months, and at 1 year.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 3 years.