A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

Inclusion Criteria:

- Male, age between 50-70 years old

- Increased PSA level >4 ng/mL

- Known prostate cancer

- Scheduled for prostatectomy not earlier than 3 days and not later than 30 days
following BR55 administration (with the exception of training cases where this
requirement is not applicable)

- Provides written informed consent and willing to comply with protocol requirements

Exclusion Criteria:

- Documented acute prostatitis or urinary tract infections

- Known to suffer from stable angina pectoris and/or proven coronary disease, or have
symptoms suspicious of coronary disease

- History of any clinically unstable cardiac condition including class III/IV cardiac
failure or right-to left shunts

- Severe cardiac rhythm disorders within the last 7 days

- Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory
distress syndrome

- Received a prostate biopsy procedure within 30 days before admission into the study

- Determined by investigator to be clinically unsuitable for the study

- Participating in a concurrent clinical trial or has participated in another clinical
trial with an investigational compound within the past 30 days