Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00021450
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 819
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter
- Secondary Outcome Measures
Name Time Method Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy Clinical disease-free 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 Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter
Trial Locations
- Locations (20)
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Saint Luke's Hospital
🇮🇪Dublin, Ireland
Bank Of Cyprus Oncology Centre
🇨🇾Nicosia, Cyprus
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Charles University Hospital
🇨🇿Hradec Kralove, Czech Republic
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre d'Oncologie Saint-Yves
🇫🇷Vannes, France
Hopital de la Ville D'Esch-sur-Alzette
🇱🇺Esch-sur-Alzette, Luxembourg
Arnhems Radiotherapeutisch Instituut
🇳🇱Arnhem, Netherlands
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa, Italy
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Institut Catala d'Oncologia - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Medical University of Gdansk
🇵🇱Gdansk, Poland
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom