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)