Cost-utility of Focal HIFU vs Prostatectomy

Inclusion Criteria:

• 45-75 yo male harboring a non-treated localized prostatic adenocarcinoma of maximumGleason score 3+4, ISUP 2 unilateral on at most maximum 2 contiguous sextants (favorable intermediate risk),with or without ipsilateral or contralateral focus ofscore 3+3 (ISUP1).

• Tumor visible on MRI and proven by systematic and/or targeted biopsies according tothe center's practices, regardless of the route used (transrectal or transpirenal)

• Or patients under active surveillance whose follow-up prostate biopsies revealunilateral ISUP2 on at most 2 contiguous sextants (favorable intermediate risk),with or without ipsilateral or contralateral Gleason 3+3 focus (ISUP1)

• Patients with several suspicious foci on MRI may be be included if only one of thesefoci is confirmed by targeted biopsies biopsies with an ISUP2 score,

• stage T1c-T2,

• with PSA <20 ng/ml,

• with prostate volume less than 150 ml,

• patient clearly informed of the study and having agreed, with sufficient time forreflection to participate by signing the study's informed consent form,

• patient affiliated to or benefiting from a social security scheme

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 FocalOne® endorectal probe introduction.

• Anatomic abnormality of the rectum or rectal mucosa.

• Presence of a urinary artificial sphincter, a penile prosthesis or intraprostaticimplant, 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-muscularanterior zone).

• Previous not controlled cancer and/or treated since less than 5 years (exceptbasocellular skin cancer).

• Patient not able to understand the trial objectives or refusing to adhere to thetrial instructions.

• Patients under law-protection.

• Patient in an ongoing research trial.

• Patient with a severe health or psychologic problem that could impair the protocolpathway.