SonoVue Guided Prostate Biopsy

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.

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)