BR55 in Prostate Cancer: an Exploratory Clinical Trial

Bracco

Status and phase

Completed

Early Phase 1

Conditions

Prostate Cancer

Treatments

Drug: BR55

Study type

Interventional

Funder types

Industry

Identifiers

NCT01253213

BR55-101

Details and patient eligibility

About

The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.

This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

Enrollment

26 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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;