SonoVue Guided Prostate Biopsy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00911027
• Date of registration: 07/05/2009
• Prospective Registration: No
• Primary sponsor: Bracco Diagnostics, Inc
• Public title: SonoVue Guided Prostate Biopsy
• Scientific 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
• Date of first enrolment: February 2009
• Target sample size: 282
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00911027
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, France, Germany, Italy, Netherlands, United Kingdom

Contacts

• Name: Maria L Storto, MD
• Affiliation: Bracco Diagnostics, Inc

Key inclusion & exclusion 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)



Age minimum: 40 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Contrast-enhanced ultrasound guided biopsy

Procedure: ultrasound guided systematic biopsy

Primary Outcome(s)

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]

Secondary Outcome(s)

Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores. [Time Frame: 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]

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]

Secondary ID(s)

BR1-127

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bracco Imaging SpA