Trial Information

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

OBJECTIVES:

- Compare the overall and cancer-specific survival of patients with prostate cancer
treated with bicalutamide alone followed by bicalutamide with either goserelin or
bilateral orchiectomy vs observation followed by bicalutamide with either goserelin or
bilateral orchiectomy.

- Compare the time to first and second clinical progression in patients treated with
these regimens.

- Compare the quality of life, including potency, of patients treated with these
regimens.

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.

- Arm I: Patients receive oral bicalutamide once daily. At first symptomatic disease
progression, patients also receive goserelin subcutaneously once every 28 or 84 days or
undergo bilateral orchiectomy. At second disease progression, patients discontinue
bicalutamide.

- Arm II: Patients are observed until first symptomatic disease progression. At first
disease progression, patients receive bicalutamide with either goserelin or bilateral
orchiectomy as in arm I. Patients discontinue bicalutamide as in arm I.

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.