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

SonoVue Guided Prostate Biopsy

Sponsors

Lead sponsor: Bracco Diagnostics, Inc

Collaborator: Bracco Imaging S.p.A.

Source Bracco Diagnostics, Inc
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.

Overall Status Terminated
Start Date February 2009
Completion Date March 2011
Primary Completion Date March 2011
Phase Phase 3
Study Type Interventional
Primary 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. Day 1
Secondary 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 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. Day 1
Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores. Day 1
Enrollment 282
Condition
Intervention

Intervention type: Drug

Intervention name: Contrast-enhanced ultrasound guided biopsy

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

Arm group label: SonoVue guided biopsy

Other name: SonoVue guided biopsy

Intervention type: Procedure

Intervention name: ultrasound guided systematic biopsy

Description: Current practice of ultrasound guided systematic biopsy

Arm group label: Systematic biopsy

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)

Gender: Male

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

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

Austria

Belgium

France

Germany

Italy

Netherlands

United Kingdom

Verification Date

April 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: SonoVue guided biopsy

Arm group type: Experimental

Arm group label: Systematic biopsy

Arm group type: Other

Study Design Info

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov