Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma

Inclusion criteria

• prostate adenocarcinoma
• WHO performance index ≤ 1
• Patient presenting one of the following cases:

• Low risk: ≤ T2a and Gleason 6 (3 + 3) and PSA <10 ng / ml
• Intermediate risk: T2b-T2c or Gleason 7 or PSA <15 ng / ml
• High localized risk: T3a and Gleason ≤7 and PSA <15 ng / ml
• Disease presenting a risk of lymph node involvement <15%
• Absence of pelvic or lumbar aortic lymphadenopathy
• Absence of bone or visceral metastasis
• IPSS score <15 or ≤ 7
• Prostate volume estimated by MRI or ultrasound < 90cc
• If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.
• Absence of prior pelvic radiotherapy
• No surgical treatment for prostate cancer

Exclusion criteria

• Prostate cancer of histology other than adenocarcinoma
• Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator
• Patient diagnosed N1 during imaging workup or pN1
• Serum PSA level ≥ 15 ng / ml
• IPSS score ≥ 15 or IPSS score> 7 if alpha blocking urological treatment in progress
• Prostate volume estimated on MRI or ultrasound> 90 cc
• Involvement of seminal vesicles on MRI
• History of cancer in the 5 years preceding entry into the trial
• History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy
• rectal surgery
• pelvic irradiation
• Patient treated with antineoplastic or medication which may include Methotrexate
• Hormone therapy started for more than 60 days at the time of inclusion
• Severe uncontrolled hypertension
• Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization
• Patient on immunosuppressant
• Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium