Quantitative Prostate Cancer Contrast-enhanced Ultrasound (SONOCAP)

Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound (CEUS) using SonoVue® as contrast agent.

The software analyses the ascending phase of enhancement (wash-in) and calculates the mode and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis of cancer is based on the combination of these two parameters.

The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound (CEUS).

The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time to peak, the transit time and the area under the enhancement curve (parameters not used by the VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign peripheral zone at contrast-enhanced ultrasound (CEUS).

The study will enroll patients referred for prostate biopsy. The US transrectal probe will be inserted and the local anesthesia performed as per the institution's standard of care protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer (e.g. based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue® will then be injected and the ultrasound enhancement of this plane will be recorded during 2 minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the recording is still on, so that it will be possible to calculate quantitative enhancement parameters at the exact location of the biopsy.

Then, the operator will choose a plane that is likely not to contain cancer in the opposite prostate lobe and the same process will be repeated with injection of the second half of the vial.

The rest of the biopsies will be performed as per the institution's standard of care protocol.

The two recordings will be sent to Bracco's Research center in Geneva in order to:

• Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software results
• Calculate the wash-out rate, the time to peak, the transit time and the area under the enhancement curve at the biopsy location.

The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy samples) will be processed and analysed at the institution's department of Pathology and their results will be blinded to the Bracco's Research center.

The correlation between the biopsy results, the VueBoxTM-Prostate software results and the wash-out rate, time to peak, transit time and area under the enhancement curve will be performed by the study investigator.

In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: biopsy sample performed after the SonoVue® injection

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 36076 Bordeaux cedex
    • Recruiting
    • CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte
    • Contact: Nicolas GRENIER, MD, PhD; Phone Number: +33 556 795 599; Email: nicolas.grenier@chu-bordeaux.fr
    • Principal Investigator: Nicolas GRENIER, MD, PhD
  • Lyon, France, 69003
    • Recruiting
    • Hospices civils de Lyon - Hôpital Edouard Herriot
    • Contact: Fanny CROS; Phone Number: +33 (0)4 72 11 04 00; Email: fanny.cros@chu-lyon.fr
    • Contact: Olivier Rouvière, Pr; Phone Number: +33 (0)4 72 11 09 51; Email: olivier.rouviere@chu-lyon.Fr
    • Principal Investigator: Olivier Rouvière, Pr
  • Paris, France, 75743 Paris cedex 15
    • Recruiting
    • Assistance Publique Hôpitaux de Paris - Hôpital Necker - Service de Radiologie adultes
    • Contact: Jean-Michel CORREAS, MD, PhD; Phone Number: +33 144 495 312; Email: jean-michel.correas@nck.aphp.fr
    • Principal Investigator: Jean-Michel CORREAS, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patient referred for prostate biopsy
• Informed consent signed
• Patient affiliated to the French Health Insurance

Exclusion Criteria:

• History of allergy to SonoVue®
• History of myocardial infarction or angor pectoris
• History of severe pulmonary arterial hypertension (> 90 mm Hg)
• History of previous treatment for prostate cancer (radiation therapy, brachytherapy, high-intensity focused ultrasound, etc…)
• History of hormone therapy for prostate cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: biopsy sample performed after the SonoVue® injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal peripheral zone	Using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing aggressive prostate cancer (Gleason score ≥7) from normal peripheral zone	using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored	Day 1
Diagnostic performance (sensitivity and specificity) of the of the wash-out rate, time to peak, transit time and area under the enhancement curve in distinguishing prostate cancer from normal peripheral zone	using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored	Day 1
Diagnostic performance (sensitivity and specificity) of the of the wash-out rate, time to peak, transit time and area under the enhancement curve in distinguishing aggressive prostate cancer (Gleason score ≥7) prostate cancer from normal peripheral zone	using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Olivier ROUVIERE, Professor, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2015
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Prostate cancer; Contrast-enhanced ultrasound
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2013.800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No