Cost-utility of Focal HIFU vs Prostatectomy

Exclusion Criteria

• •Metastatic prostate cancer.
• •Gleason score \> 3+4 (ISUP\>2).
• •Adenoma prostate carcinoma Cribriform or intraductal.
• •Previous treatment anterior for the same cancer, whatever modality.
• •Contra-indication to pelvic MRI with gadolinium injection.
• •Contra-indication to surgery or general anesthesia.
• •Patient who refuse the one-year follow-up control biopsy after F-HIFU.
• •Presence of implant (stent, catheter) less than 1 cm from the treatment area.
• •Urinary or rectal fistula.
• •Anal or rectal stenosis or any other abnormality that may interfere with the Focal One® endorectal probe introduction.
• •Anatomic abnormality of the rectum or rectal mucosa.
• •Presence of a urinary artificial sphincter, a penile prosthesis or intraprostatic implant, i.e. urethral prosthesis.
• •Bladder neck and/or urethral stenosis or sclerosis.
• •Inflammatory bowel disease (colon or rectum).
• •Ongoing UTI (should be treated before the F-HIFU or the RP).
• •Previous anal or rectal surgery that may interfere with the anal probe introduction.
• •Latex allergy.
• •Rectal wall thickness \> 10 mm.
• •Tumor not accessible to a F-HIFU treatment (tumors located in the fibro-muscular anterior zone).
• •Previous not controlled cancer and/or treated since less than 5 years (except basocellular skin cancer).
• •Patient not able to understand the trial objectives or refusing to adhere to the trial instructions.
• •Patients under law-protection.
• •Patient in an ongoing research trial.
• •Patient with a severe health or psychologic problem that could impair the protocol pathway.