SonoVue Guided Prostate Biopsy

April 24, 2012 updated by: Bracco Diagnostics, Inc

A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer

This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University Innsbruck
  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital K.U. Leuven
  • France
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Paris, France, 75743
        • Hopital Necker-Enfants Malades
      • Tours, France, 37044
        • CHRU Tours - Hôpital Bretonneau
  • Germany
      • Berlin, Germany, 10117
        • Institut für Radiologie der Charité
      • Hamburg, Germany, 20246
        • Martini-Klinik, Prostate Cancer Center
      • Munich, Germany, 81377
        • Urologische Klinik und Poliklinik
  • Italy
      • Bologna, Italy, 40138
        • Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
      • Como, Italy, 22100
        • Ospedale Valduce
      • Milan, Italy, 20100
        • European Institute of Oncology
      • Milan, Italy, 20132
        • I.R.C.C.S. San Raffaele
      • Palermo, Italy, 90127
        • University of Palermo
      • Trieste, Italy, 34149
        • University of Trieste
  • Netherlands
      • Amsterdam, Netherlands, 1100 DD
        • AMC University Amsterdam
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC
  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Imperial College NHS Trust - Charing Cross

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patient, age ≥ 40 years old
  • Optimization part only: Diagnosis of prostate cancer
  • Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
  • Written Informed Consent and willing to comply with protocol requirements

Exclusion Criteria:

  • Documented acute prostatitis or urinary tract infections
  • Known allergy to sulphur hexafluoride micro bubbles
  • Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
  • evolving or ongoing myocardial infarction
  • typical angina at rest within the previous 7 days
  • significant worsening of cardiac symptoms within the previous 7 days
  • recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
  • acute cardiac failure, class III/IV cardiac failure
  • severe cardiac rhythm disorders
  • right-to-left shunts
  • Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
  • Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
  • Determined by the Investigator that the patient is clinically unsuitable for the study
  • Participation in a concurrent clinical trial or in another trial within the past 30 days
  • Repeated participation in this trial (the patient should not be enrolled twice in the present study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SonoVue guided biopsy
Drug: Contrast-enhanced ultrasound guided biopsy

One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part

One to four bolus (each 2.4mL) of SonoVue per patient in the main part

Other Names:
  • SonoVue guided biopsy
Other: Systematic biopsy
Procedure: ultrasound guided systematic biopsy
Current practice of ultrasound guided systematic biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure.
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy
Time Frame: Day 1
Day 1
Assessment of potentiality of SonoVue guided biopsy to increase % of positive bioptic cores compared to % of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures.
Time Frame: Day 1
Day 1
Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Collaborators

Bracco Imaging S.p.A.

Investigators

  • Study Chair: Maria L Storto, MD, Bracco Diagnostics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR1-127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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