Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

Hospices Civils de Lyon174 enrolled

Overview

The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (\>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

174

Conditions

Prostate Cancer

Interventions

HIFU treatment will be conducted with the Focal One® device. 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.

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (14)

Polyclinique du parc Rambot

Aix-en-Provence, France

Clinique Saint-Vincent

Besançon, France

Service d'Urologie, Clinique Tivoli Ducos

Bordeaux, France

Groupe Hospitalier Pellegrin - CHU

Bordeaux, France

Hôpital L. Pasteur, Hôpitaux Civils de Colmar

Colmar, France

Service d'Urologie CHRU de Lille, Hôpital HURIEZ

Lille, France

Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

Lille, France

Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

Lyon, France

Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

Marseille, France

Département d'Urologie, Institut Montsouris

Paris, France

...and 4 more locations

Outcomes

Primary Outcomes

patient proportion with controlled disease (Control of the pathology)

The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 12 months after inclusion.

Time frame: 12 months

Secondary Outcomes

proportion of patients needing additional treatment

The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 12 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.

Time frame: 12 months

proportion of patients needing additional treatment

The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 48 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.

Time frame: 48 months

proportion of patients needing additional radical treatment

The objective is to determine the proportion of patients needing additional radical treatment at 12 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.

Time frame: 12 months

proportion of patients needing additional radical treatment

The objective is to determine the proportion of patients needing additional radical treatment at 48 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.

Time frame: 48 months

rate of positive biopsies

The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 12 months.

Time frame: 12 months

rate of positive biopsies

The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 24 months.

Time frame: 24 months

rate of positive biopsies

The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 48 months.

Time frame: 48 months

clinically significant cancer rate

The clinically significant cancer rate (Gleason 7 or invasion of more than 3 biopsies or invasion\> 3 mm regardless of Gleason) in the untreated lobe and the treated lobe will be measured and will be used to evaluate the carcinologic evolution at 48 months.

Time frame: 48 months

Gleason score

Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 12 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.

Time frame: 12 months

Gleason score

Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 24 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.

Time frame: 24 months

Gleason score

Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 48 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.

Time frame: 48 months

Appearance of another cancerous focus in the other half of the prostate

Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 12 months.

Time frame: 12 months

Appearance of another cancerous focus in the other half of the prostate

Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 24 months.

Time frame: 24 months

Appearance of another cancerous focus in the other half of the prostate

Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 48 months.

Time frame: 48 months

Appearance of metastases

Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 12 months.

Time frame: 12 months

Appearance of metastases

Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 24 months.

Time frame: 24 months

Appearance of metastases

Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 48 months.

Time frame: 48 months

Appearance of an extra capsular extension

Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 12 months.

Time frame: 12 months

Appearance of an extra capsular extension

Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 24 months.

Time frame: 24 months

Appearance of an extra capsular extension

Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 48 months.

Time frame: 48 months

Overall survival

Overall survival at 48 months will be measured from the date of inclusion to the date of death, all causes of death combined or the date of last new or point date to 48 months.

Time frame: 48 months

Prostate cancer specific survival

Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of death related to prostate cancer or the date of last new or point date to 48 months

Time frame: 48 months

Recurrence free survival

Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of first metastasis , or the date of last new or point date to 48 months.

Time frame: 48 months

Proportion of serious adverse effect

comparison of the proposition of serious adverse effect at 48 months

Time frame: 48 months

Quality of life score

quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the better the quality of life.