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Table 1 Inclusion and exclusion criteria

From: BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol

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