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

Inclusion Criteria:

   - Male, age between 50-70 years old

   - Increased Prostate-Specific Antigen (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)

   - Provided 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

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