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