Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After 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

Inclusion criteria

• Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage)
• R0 or R1
• pN0 or pNx
• Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage
• PSA ≤2 ng/mL at moment of the randomisation
• No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
• Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
• Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
• Creatinine <140 µmol/L (or clearance >60 mL/min)
• Normal fasting glucose
• Eastern Cooperative Oncology Group (ECOG) ≤1
• Age >18 years
• Life expectancy ≥10 years
• Patients with invasive cancer in complete response for more than five years are eligible
• Patients who have received the information sheet and signed the informed consent form
• Patients with a public or a private health insurance coverage

Exclusion criteria

• Prostate cancer histology other than adenocarcinoma
• Patients pN1, N1 and M1
• History of pelvic radiotherapy
• Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
• Testosterone ≤0.5 ng/mL
• History of surgical castration
• Previous treatment by hormonotherapy
• Antineoplastic treatment in progress
• History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
• Known pituitary adenoma
• Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic)
• Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec
• Individual deprived of liberty or placed under the authority of a tutor
• Unable to undergo medical monitoring test for geographical, social or psychological reasons
• Known hypersensitivity to the treatment in test
• Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this