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SonoVue Guided Prostate Biopsy

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Contrast-enhanced ultrasound guided biopsy

ultrasound guided systematic biopsy

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate, Cancer, Biopsy, Guided, Contrast, Enhanced, SonoVue, Suspicion of prostate cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Medical University Innsbruck
University Hospital K.U. Leuven
Hôpital Edouard Herriot
Hôpital Necker-Enfants Malades
CHRU Tours - Hôpital Bretonneau
Institut für Radiologie der Charité
Martini-Klinik, Prostate Cancer Center
Urologische Klinik und Poliklinik
Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
Ospedale Valduce
European Institute of Oncology
I.R.C.C.S. San Raffaele
University of Palermo
University of Trieste
AMC University Amsterdam
Erasmus MC
Imperial College NHS Trust - Charing Cross

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SonoVue guided biopsy

Systematic biopsy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy

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.

Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.

Full Information

NCT ID

NCT00911027

First Posted

May 7, 2009

Last Updated

April 24, 2012

Sponsor

Bracco Diagnostics, Inc

Collaborators

Bracco Imaging S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT00911027

Brief Title

SonoVue Guided Prostate Biopsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Terminated

Why Stopped

Failure to meet primary objective

Study Start Date

February 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bracco Diagnostics, Inc

Collaborators

Bracco Imaging S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate, Cancer, Biopsy, Guided, Contrast, Enhanced, SonoVue, Suspicion of prostate cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

282 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SonoVue guided biopsy

Arm Type

Experimental

Arm Title

Systematic biopsy

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Contrast-enhanced ultrasound guided biopsy

Other Intervention Name(s)

SonoVue guided biopsy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

ultrasound guided systematic biopsy

Intervention Description

Current practice of ultrasound guided systematic biopsy

Primary Outcome Measure Information:

Title

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

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

Title

Time Frame

Day 1

Title

Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.

Time Frame

Day 1

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria L Storto, MD

Organizational Affiliation

Bracco Diagnostics, Inc

Official's Role

Study Chair

Facility Information:

Facility Name

Medical University Innsbruck

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

University Hospital K.U. Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Hôpital Edouard Herriot

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

Hôpital Necker-Enfants Malades

City

Paris

ZIP/Postal Code

75743

Country

France

Facility Name

CHRU Tours - Hôpital Bretonneau

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Institut für Radiologie der Charité

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Martini-Klinik, Prostate Cancer Center

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Urologische Klinik und Poliklinik

City

Munich

ZIP/Postal Code

81377

Country

Germany

Facility Name

Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Ospedale Valduce

City

Como

ZIP/Postal Code

22100

Country

Italy

Facility Name

European Institute of Oncology

City

Milan

ZIP/Postal Code

20100

Country

Italy

Facility Name

I.R.C.C.S. San Raffaele

City

Milan

ZIP/Postal Code

20132

Country

Italy

Facility Name

University of Palermo

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

University of Trieste

City

Trieste

ZIP/Postal Code

34149

Country

Italy

Facility Name

AMC University Amsterdam

City

Amsterdam

ZIP/Postal Code

1100 DD

Country

Netherlands

Facility Name

Erasmus MC

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Imperial College NHS Trust - Charing Cross

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

12. IPD Sharing Statement

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SonoVue Guided Prostate Biopsy

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