Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	80 and under	Other	EORTC-GU-30991 NCT00014586

Objectives

1. 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.
2. Compare the time to first and second clinical progression in patients treated with these regimens.
3. Compare the quality of life, including potency, of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed prostate cancer
  • T1-3, any G (any Gleason), N0 or NX



• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• 80 and under

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancy within the past 5 years except adequately treated basal cell skin cancer
• No psychological, personal, sociological, or geographical condition that would preclude study

Expected Enrollment

Approximately 1266 patients (633 per treatment arm) will be accrued for this study within 5 years.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Gerald Mickisch, MD, Protocol chair		Ph: 49-421-870-0300

Registry Information
Official Title		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
Trial Start Date		2001-01-10
Registered in ClinicalTrials.gov		NCT00014586
Date Submitted to PDQ		2001-02-22
Information Last Verified		2001-05-14

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