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

NCT02662673 | Completed

• 1 other identifier: 2013-817
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

HIFU; Prostate Cancer; Focal; Quality of life; Index study

Outcome Measures

Primary Outcomes (1)

• Negative Biopsy Rate in the treated area

  Between 6 to 12 months after treatment

Secondary Outcomes (7)

• Evaluation of positive biopsy rate in the untreated areas

  Between 6 to 12 months after treatment

• Rate of side effects

  At 12 and 24 months after treatment

• Prostate Specific Antigen (PSA) level evolution after treatment

  24 months

• Prostate Symptoms

  1 and 2 years(s)

• Continence

  1 and 2 years(s)

Study Arms (1)

Localized prostate cancer, Focal treatment.

OTHER

Device: Focal High Intensity Focused Ultrasound (HIFU) treatment

Interventions

Focal High Intensity Focused Ultrasound (HIFU) treatment 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.

Localized prostate cancer, Focal treatment.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 25, 2016
• Study Start: January 13, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 23, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

FR (1)