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

NCT00021450 | Completed Phase 3

• 1 other identifier: EORTC-22991
• Study Type: interventional
• Target: 819
• Locations: 11 countries
• Sites: 20

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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter

Secondary Outcomes (6)

• Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter

• Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter

• Local control as measured by Gray scale every 6 months until year 5, and annually thereafter

• Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy

• Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter

Interventions

bicalutamide DRUG

goserelin acetate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (20)

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Bank Of Cyprus Oncology Centre

Nicosia, 2006 Strovolos, Cyprus

Location

Charles University Hospital

Hradec Králové, 500 05, Czechia

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Centre d'Oncologie Saint-Yves

Vannes, 56001, France

Location

Saint Luke's Hospital

Dublin, 6, Ireland

Location

Spedali Civili di Brescia

Brescia, 25124, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Hopital de la Ville D'Esch-sur-Alzette

Esch-sur-Alzette, L-4240, Luxembourg

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Institut Catala d'Oncologia - Hospital Duran i Reynals

Barcelona, 08907, Spain

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 19038468 BACKGROUND

• 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.

  PMID: 19682889 RESULT

• 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.

  PMID: 34310202 DERIVED

• 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.

  PMID: 26976418 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Goserelin; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Michel Bolla, MD

  CHU de Grenoble - Hopital de la Tronche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: April 1, 2008
• Study Completion: January 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-09

Locations

NL (3); BE (3); LU (1); ES (1); CY (1); CZ (1); IE (1); IT (2); FR (5); PL (1); GB (1)