SonoVue Guided Prostate Biopsy

Phase 3

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Contrast-enhanced ultrasound guided biopsy; Procedure: ultrasound guided systematic biopsy

• Registration Number: NCT00911027
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 282

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SonoVue guided biopsy	Contrast-enhanced ultrasound guided biopsy	-
Systematic biopsy	ultrasound guided systematic biopsy	-

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (17)

I.R.C.C.S. San Raffaele; 🇮🇹 Milan, Italy

University of Palermo; 🇮🇹 Palermo, Italy

Ospedale Valduce; 🇮🇹 Como, Italy

Urologische Klinik und Poliklinik; 🇩🇪 Munich, Germany

Institut für Radiologie der Charité; 🇩🇪 Berlin, Germany

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

University Hospital K.U. Leuven; 🇧🇪 Leuven, Belgium

AMC University Amsterdam; 🇳🇱 Amsterdam, Netherlands

Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"; 🇮🇹 Bologna, Italy

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

European Institute of Oncology; 🇮🇹 Milan, Italy

University of Trieste; 🇮🇹 Trieste, Italy

Imperial College NHS Trust - Charing Cross; 🇬🇧 London, United Kingdom

CHRU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Martini-Klinik, Prostate Cancer Center; 🇩🇪 Hamburg, Germany

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France