Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00021450|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 2, 2016
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: goserelin acetate Procedure: adjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||819 participants|
|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|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||January 2016|
- Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter
- 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
- Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021450
|Academisch Ziekenhuis der Vrije Universiteit Brussel|
|Brussels, Belgium, 1090|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Leuven, Belgium, B-3000|
|Bank Of Cyprus Oncology Centre|
|Nicosia, Cyprus, 2006 Strovolos|
|Charles University Hospital|
|Hradec Kralove, Czech Republic, 500 05|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|CHU de Grenoble - Hopital de la Tronche|
|Grenoble, France, 38043|
|Centre Paul Strauss|
|Strasbourg, France, 67085|
|Centre d'Oncologie Saint-Yves|
|Vannes, France, 56001|
|Saint Luke's Hospital|
|Dublin, Ireland, 6|
|Spedali Civili di Brescia|
|Brescia, Italy, 25124|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Hopital de la Ville D'Esch-sur-Alzette|
|Esch-sur-Alzette, Luxembourg, L-4240|
|Arnhems Radiotherapeutisch Instituut|
|Arnhem, Netherlands, 6815 AD|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|Dr. Bernard Verbeeten Instituut|
|Tilburg, Netherlands, 5042 SB|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|Institut Catala d'Oncologia - Hospital Duran i Reynals|
|Barcelona, Spain, 08907|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Study Chair:||Michel Bolla, MD||CHU de Grenoble - Hopital de la Tronche|