Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device

NCT ID: NCT02662673

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-13
• Study Completion Date: 2017-02-23

Brief Summary

Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance.

This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.

Conditions

Localized Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Localized prostate cancer, Focal treatment.

Group Type: OTHER

Focal High Intensity Focused Ultrasound (HIFU) treatment

Intervention Type: DEVICE

Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.

Interventions

Focal High Intensity Focused Ultrasound (HIFU) treatment

Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 50 and 80 years (inclusive) with a life expectancy of more than 5 years.
• PSA ≤ 10 ng / mL.
• Initial diagnosis of localized prostate cancer (stage T1 or T2).
• Diagnosis confirmed by a multiparametric MRI and subsequent systematic and targeted prostate biopsies (at least 12 sextant biopsies and two biopsies per MRI target).
• Identification of a primary cancer site (index tumor) possibly associated with a second independent tumor (accessory tumor), provided that these tumors are separated by a sextant or the median line.
• Maximum two cancer foci, each one fulfilling the following conditions
• Gleason score of 6 AND biopsy invasion length ≥5 mm,
• OR Gleason score of 6 AND corresponding focal lesion on MRI with a PIRADS (Prostate Imaging Reporting and Data System) score ≥4/5 and a diameter ≥5 mm,
• OR Gleason score of 7 (3+4) whatever the biopsy invasion length or the MRI results may be.
• Patient with normal anal and rectal anatomy.
• Patient with a condition corresponding to an ASA (American Society of Anesthesiologists) classification 1 or 2.
• Patient for which treatment by focal HIFU (without performing an associated TURP) has been validated in Multidisciplinary meeting.
• Accepting patient monitoring constraints defined in the context of the study.
• Patient affiliated to health insurance or beneficiary a similar plan.

Exclusion Criteria

• Patient with ASA (American Society of Anesthesiologists) score 3.
• Patient clinical stage T3.
• Metastatic or distant (CT and/or MRI) lymph node.
• Patient with more than two cancer foci.
• Patients already treated for his prostate cancer (hormone therapy, radiotherapy, surgery).
• Patient having a distance between the rectal mucosa and the prostatic capsule over 8 mm.
• History of inflammatory bowel disease, rectal or urinary tract fistula.
• History of pelvic radiotherapy.
• History of bladder cancer.
• History of sclerosis of the bladder neck or urethral stricture.
• Patient with an implant located at least 1 cm of the treatment zone (stent, catheter).
• Hemorrhagic risk patient.
• Urogenital infection in progress.
• Latex allergy.
• Allergy to sulfur hexafluoride or any of the other components of SonoVue®.
• Patients with recent acute coronary syndrome or unstable ischemic heart disease: myocardial infarction phase formation or evolution, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent intervention on the coronary arteries or other factors suggesting clinical instability (eg recent ECG changes, changes in clinical or laboratory parameters), acute heart failure, heart failure stage III or IV, or severe rhythm disorders (contra-indications to the use of SonoVue®).
• Patient with a right to left shunt, severe pulmonary hypertension (pulmonary artery pressure> 90 mm Hg), uncontrolled systemic hypertension.
• Patient with respiratory distress syndrome.
• Patient with severe chronic obstructive pulmonary disease.
• Patient with acute endocarditis, prosthetic valve holder, acute systemic inflammation and / or sepsis, hyper coagulation status and / or recent thromboembolism.
• Patient on life support or suffering from unstable neurological diseases.
• Contra-indication for MRI (pacemakers, metal prosthesis, etc ...).
• Patient participating or having participated in another clinical study within the last 30 days.
• Patient deprived of liberty following a judicial or administrative decision.
• Patient under guardianship or curatorship.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, , France

Countries

France

Other Identifiers

2013-817

Identifier Type: -

Identifier Source: org_study_id