SonoVue Guided Prostate Biopsy

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…