Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer

Exclusion Criteria

• •Contraindications to treatment with HIFU-F:
• •* Tumor not accessible.
• •* Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
• •* History of pelvic irradiation
• •* Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
• •* Fistula of the urinary tract or rectum.
• •* Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
• •* Anatomical abnormality of the rectum or rectal mucosa.
• •* Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
• •* History of intestinal inflammatory pathology.
• •* Uro-genital infection in progress (the infection to be treated before HIFU treatment).
• •* Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
• •* Allergy to latex.
• •* Thickness of the rectal wall\> 10mm.
• •TURP indication. Bladder neck incision is allowed .
• •Patient with a medical contraindication to Sonovue® injection.
• •Patient with a medical contraindication on MRI.
• •Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
• •History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
• •History of sclerosis of the bladder neck or urethral stenosis.
• •Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
• •Patients with unstable neurological pathology.
• •Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
• •Legal person protected by law.
• •Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.