Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results

This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.

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

All adverse events that occurred from the time the patient signed the Informed Consent Form until 24 hours after the last administration of BR55 were recorded.