Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

NCT ID: NCT00021450

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 819 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

bicalutamide

Intervention Type: DRUG

goserelin acetate

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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 (UICC 1997 classification) OR
• T2a, N0, M0 (UICC 1997 classification)
• 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

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Bolla, MD

Role: STUDY_CHAIR

CHU de Grenoble - Hopital de la Tronche

Locations

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Bank Of Cyprus Oncology Centre

Nicosia, , Cyprus

Charles University Hospital

Hradec Králové, , Czechia

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, , France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, , France

CHU de Grenoble - Hopital de la Tronche

Grenoble, , France

Centre Paul Strauss

Strasbourg, , France

Centre d'Oncologie Saint-Yves

Vannes, , France

Saint Luke's Hospital

Dublin, , Ireland

Spedali Civili di Brescia

Brescia, , Italy

Istituto Nazionale per la Ricerca sul Cancro

Genoa, , Italy

Hopital de la Ville D'Esch-sur-Alzette

Esch-sur-Alzette, , Luxembourg

Arnhems Radiotherapeutisch Instituut

Arnhem, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

Dr. Bernard Verbeeten Instituut

Tilburg, , Netherlands

Medical University of Gdansk

Gdansk, , Poland

Institut Catala d'Oncologia - Hospital Duran i Reynals

Barcelona, , Spain

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, United Kingdom

Countries

Belgium; Cyprus; Czechia; France; Ireland; Italy; Luxembourg; Netherlands; Poland; Spain; United Kingdom

References

Matzinger O, Poortmans P, Giraud JY, Maingon P, Budiharto T, van den Bergh AC, Davis JB, Musat E, Ataman F, Huyskens DP, Gulyban A, Bolla M; EORTC Radiation Oncology Group. Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review. Radiother Oncol. 2009 Mar;90(3):285-90. doi: 10.1016/j.radonc.2008.10.022. Epub 2008 Nov 27.

Reference Type: BACKGROUND

PMID: 19038468 (View on PubMed)

Matzinger O, Duclos F, van den Bergh A, Carrie C, Villa S, Kitsios P, Poortmans P, Sundar S, van der Steen-Banasik EM, Gulyban A, Collette L, Bolla M; EORTC Radiation Oncology Group. Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991. Eur J Cancer. 2009 Nov;45(16):2825-34. doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.

Reference Type: RESULT

PMID: 19682889 (View on PubMed)

Bolla M, Neven A, Maingon P, Carrie C, Boladeras A, Andreopoulos D, Engelen A, Sundar S, van der Steen-Banasik EM, Armstrong J, Peignaux-Casasnovas K, Boustani J, Herrera FG, Pieters BR, Slot A, Bahl A, Scrase CD, Azria D, Jansa J, O'Sullivan JM, Van Den Bergh ACM, Collette L; EORTC Radiation Oncology Group. Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease. J Clin Oncol. 2021 Sep 20;39(27):3022-3033. doi: 10.1200/JCO.21.00855. Epub 2021 Jul 26.

Reference Type: DERIVED

PMID: 34310202 (View on PubMed)

Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, Sundar S, van der Steen-Banasik EM, Armstrong J, Bosset JF, Herrera FG, Pieters B, Slot A, Bahl A, Ben-Yosef R, Boehmer D, Scrase C, Renard L, Shash E, Coens C, van den Bergh AC, Collette L. Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991. J Clin Oncol. 2016 May 20;34(15):1748-56. doi: 10.1200/JCO.2015.64.8055. Epub 2016 Mar 14.

Reference Type: DERIVED

PMID: 26976418 (View on PubMed)

Other Identifiers

EORTC-22991

Identifier Type: -

Identifier Source: secondary_id

EORTC-22991

Identifier Type: -

Identifier Source: org_study_id