Use of a Biodegradable Balloon for the Treatment of Prostate Cancer by Intensity Modulated Radiotherapy (BioPro-RCMI)

Inclusion Criteria:

1. Patient over 18 years old
2. With a localized adenocarcinoma of the prostate

   * of intermediate risk of D'AMICO
   * and of stage MRI \< T3
3. Requiring a treatment with Intensity Modulated Radiotherapy
4. PSA (Prostate-Specific Antigen) levels ≤ 20 ng/mL before external beam radiotherapy
5. Prostate volume \> 15 cc
6. Short hormone therapy possibly associated (4-6 months)
7. Patient without clinical signs of progressive disease (Performing a bone scan and a CT scan is optional)
8. Performance status ECOG (Eastern Cooperative Oncology Group) ≤ 1
9. Life expectancy ≥ 10 years
10. Informed consent signed

Exclusion Criteria:

1. Incompatibility to the implantation of a Bioprotect balloon :

   * ongoing anticoagulant by vitamin K antagonist (VKA) or heparintherapy
   * patient with immunosuppression or with serious chronic diseases such as heart failure, cirrhosis, chronic kidney failure, colic or rectal digestive inflammatory disease
   * history of prostatitis or of lower gastrointestinal infection treated or ongoing
   * history of recto-colic inflammatory disease or of repeated prostatic resections
   * untreated perineal wound
2. Prior treatment with hormone therapy
3. History of another invasive cancer within 5 years prior to study entry (with the exception of a treated basal cell skin carcinoma)
4. History of pelvic radiotherapy
5. Severe hypertension non controlled by an adapted treatment (≥ 160 mm Hg in systole and/or ≥ 90 mm Hg in diastole)
6. Ongoing antineoplastic therapy
7. Person deprived of liberty or under tutorship
8. Inability to submit to the medical monitoring of the study for geographical, social or psychological reasons.
9. Conformal radiotherapy without intensity modulation