BR55 in Prostate Cancer: an Exploratory Clinical Trial

Inclusion Criteria:

• Male patient, age ≥ 40 years old
• Has a histology proven focal prostate cancer lesion
• The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
• Provides written Informed Consent and is willing to comply with protocol requirement

Exclusion Criteria:

• Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
• Has documented acute prostatitis or urinary tract infections
• Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
• With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
• Has had severe cardiac rhythm disorders within the last 7 days
• Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
• Has received a prostate biopsy procedure within 30 days before admission into this study
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
• Is determined by the Investigator that the patient is clinically unsuitable for the study.
• Is incapable of understanding the language in which the information for the patient is given
• Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;