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

Prostate Cancer Clinical Trial

Official title:

Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021450
• Other study ID #: EORTC-22991
• Secondary ID: EORTC-22991
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2001
• Last updated: September 1, 2016
• Start date: April 2001
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: January 2016
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bicalutamide

• goserelin acetate

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	U.Z. Gasthuisberg	Leuven
Cyprus	Bank Of Cyprus Oncology Centre	Nicosia
Czech Republic	Charles University Hospital	Hradec Kralove
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
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
Ireland	Saint Luke's Hospital	Dublin
Italy	Spedali Civili di Brescia	Brescia
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa
Luxembourg	Hopital de la Ville D'Esch-sur-Alzette	Esch-sur-Alzette
Netherlands	Arnhems Radiotherapeutisch Instituut	Arnhem
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Poland	Medical University of Gdansk	Gdansk
Spain	Institut Catala d'Oncologia - Hospital Duran i Reynals	Barcelona
United Kingdom	Belfast City Hospital Trust Incorporating Belvoir Park Hospital	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Cyprus,  Czech Republic,  France,  Ireland,  Italy,  Luxembourg,  Netherlands,  Poland,  Spain,  United Kingdom, 

References & Publications (2)

Matzinger O, Duclos F, van den Bergh A, Carrie C, Villà 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter			No
Secondary	Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter			No
Secondary	Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter			No
Secondary	Local control as measured by Gray scale every 6 months until year 5, and annually thereafter			No
Secondary	Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy			Yes
Secondary	Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter			Yes
Secondary	Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter			No