The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
298
Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume.
Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms
Time frame: 5 years
The evaluation of the overall survival at 5 years.
All cause mortality
Time frame: 5 years
The evaluation of the specific survival at 5 years
Mortality due to prostate cancer
Time frame: 5 years
The evaluation of the survival without any metastatic evolution at 5 years
Time frame: 5 years
The study of all toxicities
The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)
Time frame: 5 years
Medical and economical evaluation.
The complete medical and economical evaluation of the strategies
Time frame: 5 years
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Clinique Claude Bernard
Albi, France
RECRUITINGCHU Jean MINJOZ
Besançon, France
NOT_YET_RECRUITINGClinique Tivoli
Bordeaux, France
RECRUITINGInstitut Bergonie
Bordeaux, France
RECRUITINGCHRU Morvan
Brest, France
RECRUITINGCentre Francois Baclesse
Caen, France
NOT_YET_RECRUITINGCentre Georges François Leclerc
Dijon, France
RECRUITINGHopital de la Tronche
Grenoble, France
RECRUITINGCentre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
Lyon, France
RECRUITINGInstitut Paoli Calmette
Marseille, France
RECRUITING...and 19 more locations