Assessment of HIFU-induced Prostate Necrosis With Shear-wave Ultrasound Elastography

NCT01729442 | Completed

• 1 other identifier: 2012.730
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy. It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result. CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient. Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation. The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy. SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE. The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS. The secondary endpoints are:

• The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1,
• Adverse events related to SWUE. The study will last 40 months.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Measurement of the thickness of undestroyed parenchyma

  Briefly, the thickness of undestroyed parenchyma will be measured on CEUS and D0 SWUE in the anterior, lateral and posterior parts of both prostatic lobes. The thickness (height) of undestroyed parenchyma left at both apex will also be measured. Measurements obtained with CEUS (used as reference) and SWUE will be compared.

  Day 0

Secondary Outcomes (1)

• Evolution of shear elasticity in the treated area

  D-1 / D0 / D+1

Study Arms (3)

Patients referred for first-line prostate HIFU ablation

OTHER

10 patients

Other: Shear-wave ultrasound elastography (SWUE)

Patients referred for first-line HIFU hemi-ablation

OTHER

10 patients

Other: Shear-wave ultrasound elastography (SWUE)

Patients referred for salvage HIFU after radiotherapy

OTHER

10 patients

Other: Shear-wave ultrasound elastography (SWUE)

Interventions

Shear-wave ultrasound elastography (SWUE) OTHER

Patients referred for first-line HIFU hemi-ablation; Patients referred for first-line prostate HIFU ablation; Patients referred for salvage HIFU after radiotherapy

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Prostate cancer proved by biopsy
• Prostate cancer not eligible for surgery referred for total or hemi HIFU ablation, OR prostate cancer local recurrence referred for salvage HIFU ablation
• Anal and rectal normal anatomy
• Life expectancy ≥ 5 years
• Satisfactory general condition (ASA 1 to 3)
• Informed consent signed
• Affiliation to the French social security system or equivalent social security system.

You may not qualify if:

• Patient treated by hormonotherapy
• Prostatic calcifications preventing HIFU ablation
• Distance between rectal mucosa and prostatic capsule ≥ 6 mm
• History of inflammatory bowel disease
• Sclerosis of the bladder neck or urethral stenosis
• Rectal fistula
• Ongoing urinary infection
• Impaired renal function (MDRD \< 30mL/min/1,73 m²)
• Severe BPCO
• Acute endocarditis/ Hypercoagulation/ recent thromboembolism
• Latex or sulphur hexafluoride allergy
• Contraindication to the injection of Sonovue®
• Patient on protection of the Court, under supervision or trusteeship
• Inability to express an informed consent
• Patient already enrolled in a study that could interfere with this study.

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

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 Officials

• Olivier Rouvière, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

FR (1)