Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer (FOCALE)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, HIFU focal, adverse effect, intermediate risk
Eligibility Criteria
Inclusion Criteria:
- Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14.
Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
- A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
- Gleason score= 7 (3+4).
- Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter
- PSA ≤ 15ng / ml.
- Patient affiliated with health insurance or beneficiary of an equivalent plan.
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 pelvic radiotherapy.
- 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).
- 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.
Sites / Locations
- Polyclinique du parc RambotRecruiting
- Clinique Saint-Vincent
- Service d'Urologie, Clinique Tivoli DucosRecruiting
- Groupe Hospitalier Pellegrin - CHURecruiting
- Hôpital L. Pasteur, Hôpitaux Civils de ColmarRecruiting
- Service d'Urologie CHRU de Lille, Hôpital HURIEZRecruiting
- Service d'Urologie Générale de Santé - Hôpital Privé La LouvièreRecruiting
- Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,Recruiting
- Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille NordRecruiting
- Département d'Urologie, Institut MontsourisRecruiting
- Centre Hospitalier Lyon Sud - Hospices Civils de LyonRecruiting
- Clinique Urologique Nantes Atlantis
- Service d'Urologie, Hôpital FochRecruiting
- CHU de Toulouse - Hôpital de RangueilRecruiting
- Clinique Générale Beaulieu - Swiss International Prostate Center
Arms of the Study
Arm 1
Experimental
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.