NCT00014586

Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Male
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide
DRUG	goserelin acetate
PROCEDURE	orchiectomy

Timeline

• Start date: 2001-01-01
• Primary completion: 2003-02-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

1 site across 1 country: Germany