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

Prior treatment

• 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

Other illness

• Prostate cancer of histology other than adenocarcinoma
• 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
• 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 with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium

Lab values

• Serum PSA level ≥ 15 ng / ml

Other

• Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator
• Patient diagnosed N1 during imaging workup or pN1
• 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
• Patient on immunosuppressant

• 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