RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.

Condition	Treatment or Intervention	Phase
stage II prostate cancer	Drug: bicalutamide  Drug: goserelin  Procedure: adjuvant therapy  Procedure: antiandrogen therapy  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: radiation therapy  Procedure: releasing factor agonist therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer.
• Compare the acute and late radiation-induced side effects of these regimens in these patients.
• Compare the biochemical/clinical disease-free survival, overall survival, and time to local progression in patients treated with these regimens.
• Compare the time to clinical biological failure or death in patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-7.5 weeks.
• Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo radiotherapy as in arm I. Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 5 years.

Ages Eligible for Study:  up to  80 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II prostate cancer
• T1b-c, N0, M0 with prostate-specific antigen (PSA) at least 10 ng/mL and/or Gleason score at least 7 OR
• T2a, N0, M0
• Serum PSA no greater than 50 ng/mL
• No involvement of pelvic lymph nodes

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, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No prior hormonal therapy

Radiotherapy:

• No prior pelvic radiotherapy

Surgery:

• No prior radical prostatectomy

Belgium
      Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels,  1090,  Belgium; Recruiting
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium; Recruiting
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium; Recruiting
Cyprus
      Bank Of Cyprus Oncology Centre, Nicosia,  2006 Strovolos,  Cyprus; Recruiting
Czech Republic
      Charles University Hospital, HRADEC KRALOVE,  500 05,  Czech Republic; Recruiting
France
      Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon,  21079,  France; Recruiting
      Centre d'Oncologie Saint-Yves, Vannes,  56001,  France; Recruiting
      Centre Paul Strauss, Strasbourg,  67085,  France; Recruiting
      CHR de Besancon - Hopital Jean Minjoz, Besancon,  25030,  France; Recruiting
      CHU de Grenoble - Hopital de la Tronche, Grenoble,  38043,  France; Recruiting
Ireland
      Saint Luke's Hospital, Dublin,  6,  Ireland; Recruiting
Italy
      Istituto Nazionale per la Ricerca sul Cancro, Genoa,  16132,  Italy; Recruiting
      Spedali Civili, Brescia,  25124,  Italy; Recruiting
Luxembourg
      Hopital de la Ville D'Esch-sur-Alzette, Esch-sur-Alzette,  L-4240,  Luxembourg; Recruiting
Netherlands
      Arnhems Radiotherapeutisch Instituut, ARNHEM,  6815 AD,  Netherlands; Recruiting
      Dr. Bernard Verbeeten Instituut, Tilburg,  5042 SB,  Netherlands; Recruiting
      University Medical Center Groningen, Groningen,  9700 RB,  Netherlands; Recruiting
Poland
      Medical University of Gdansk, Gdansk,  80-211,  Poland; Recruiting
Spain
      Institut Catala d'Oncologia - Hospital Duran i Reynals, Barcelona,  08907,  Spain; Recruiting

Study chairs or principal investigators

Michel Bolla, MD,  CHU de Grenoble - Hopital de la Tronche   

Study ID Numbers:  CDR0000068749; EORTC-22991; NCT00021450
Record last reviewed:  July 2003
Last Updated:  March 3, 2005
Record first received:  July 13, 2001
ClinicalTrials.gov Identifier:  NCT00021450
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08