Cost-utility of Focal HIFU vs Prostatectomy

Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer

Inclusion Criteria:50-75 yo male harboring a non-treated localized PC, with a maximum Gleason score of 3+4 , ISUP 2 and less than 50% of positive prostate biopsy (favorable intermediate risk), with or without contralateral microfocus score 3+3 (ISUP 1) of less than 3 mm.Tumor visible on MRI and biopsy-proven with systematic and targeted biopsy with at least 2 biopsies per target and 12 systematic biopsies.Tumor involving maximum 2 biopsy-proven contiguous sextants. Patients with multiple MRI targets may be included if only one target is biopsy-proven.T1c-T2 stage.PSA <20 ng/ml.Prostate volume less than 100 ml.Fully informed patient accepting, after a decent reflexion time, to participate to the study by signing a consent form.Affiliated or beneficiary patient to the social security system.Exclusion Criteria:Metastatic prostate cancer.Gleason score > 3+4 (ISUP>2).More than 50% of positive biopsies.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.