Table 1 Inclusion and exclusion criteria
Main inclusion criteria All the following must be met at the time of screening. – Patient over 18 years old – With a localized adenocarcinoma of the prostate: ○ of intermediate risk of D’AMICO ○ and of stage MRI < T3 – Requiring a treatment with Intensity Modulated Radiotherapy – PSA (Prostate-Specific Antigen) levels ≤20 ng/mL before external beam radiotherapy – Prostate volume > 15 cm3 – Short hormone therapy possibly associated (4-6 months) – Patient without clinical signs of progressive disease – Performance status ECOG (Eastern Cooperative Oncology Group) ≤ 1 – Life expectancy ≥10 years – Informed consent signed – Affiliation to a social security system | |
Main exclusion criteria – 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 repeated prostatic resections ○ history of recto-colic inflammatory disease or of lower gastrointestinal infection ○ untreated perineal wound – Prior treatment with hormone therapy (> 6 months) – History of another invasive cancer within 5 years prior to study entry (excepted a treated basal cell skin carcinoma) – History of pelvic radiotherapy – Severe hypertension non controlled by an adapted treatment (≥ 160 mmHg in systole and/or ≥ 90 mmHg in diastole) – Ongoing antineoplastic therapy – Person deprived of liberty or under tutorship – Inability to submit to the medical monitoring of the study for geographical, social or psychological reasons. – Conformal radiotherapy without intensity modulation |