Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G (Any Gleason) NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent
Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G (Any Gleason) NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent
RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known which hormone therapy regimen is most effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor differentiation grade (G3 or Gleason more than 6 vs other values), T category, comorbidity (i.e., chronic disease) (yes vs no), potency (yes vs no), type of chosen hormonal ablation (goserelin vs orchiectomy), PSA level (less than 10 ng/mL vs 10-20 ng/mL vs 20-100 ng/mL), and N status (N0 vs NX). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, every 6 months for 6 years, at each disease progression, and then annually thereafter.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 1266 patients (633 per treatment arm) will be accrued for this study within 5 years.
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
High risk defined as G3 or Gleason more than 6 or PSA more than 20 ng/mL and unfit or unwilling to undergo local curative therapy OR
Low risk defined as G1-2 or Gleason less than 7 and PSA no more than 20 ng/mL and no prior local curative therapy
Asymptomatic (pain score of 0)
PSA no more than 100 ng/mL (no more than 25 times normal)
No metastatic disease by chest x-ray, bone scan (if PSA more than 10 ng/mL or 2.5 times normal), and pelvic CT (if chance of lymph node metastases is at least 5% by Partin tables)
No bone disease that would interfere with diagnosis of metastatic disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery