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

Inclusion Criteria

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