The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.
Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy. 122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme: * Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy * Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
Time frame: 5 years
Survival without biological event
Biochemical recurrence was defined as a PSA \> nadir + 0.4 ng / mL confirmed by a second PSA\> nadir + 0.4 ng / mL in elevation.
Time frame: 5 years
Survival without clinical event
The clinical recurrence will be defined by the discovery of a local recurrence in rectal examination, the appearance of metastases by imaging or biopsy, or clinical manifestation associated with malignant disease without elevated PSA but with histological documentation or imaging.
Time frame: 5 years
Survival without metastases
Time frame: 5 years
Overall survival
Time frame: 5 years
Acute and late toxicities of the association of hormone therapy with radiotherapy
according CTC-AE v4.0
Time frame: up to 5 years
Toxicities of radiotherapy
according CTC-AE v4.0
Time frame: up to 5 years
Patient Quality of life
QLQ-C30, QLQ-PR25 and IPSS
Time frame: up to 5 years after the end of the radiotherapy
kinetics of testosterone
Time frame: up to 12 months after the end of the radiotherapy and after biological release
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Institut de Cancérologie de l'Ouest -Site Paul Papin
Angers, France
Institut Sainte Catherine
Avignon, France
Chu Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
Centre d'oncologie - Clinique Pasteur
Brest, France
Centre François Baclesse
Caen, France
Centre hospitalier de Chambéry
Chambéry, France
Hôpital Henri Mondor
Créteil, France
Centre d'oncologie et de radiothérapie du Parc
Dijon, France
Centre Georges François Leclerc
Dijon, France
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