SonoVue Guided Prostate Biopsy

Bracco

Status and phase

Terminated

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Contrast-enhanced ultrasound guided biopsy

Procedure: ultrasound guided systematic biopsy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00911027

BR1-127

Details and patient eligibility

About

This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.

Enrollment

282 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male patient, age ≥ 40 years old
Optimization part only: Diagnosis of prostate cancer
Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
Written Informed Consent and willing to comply with protocol requirements

Exclusion criteria

Documented acute prostatitis or urinary tract infections
Known allergy to sulphur hexafluoride micro bubbles
Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
evolving or ongoing myocardial infarction
typical angina at rest within the previous 7 days
significant worsening of cardiac symptoms within the previous 7 days
recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
acute cardiac failure, class III/IV cardiac failure
severe cardiac rhythm disorders
right-to-left shunts
Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
Determined by the Investigator that the patient is clinically unsuitable for the study
Participation in a concurrent clinical trial or in another trial within the past 30 days
Repeated participation in this trial (the patient should not be enrolled twice in the present study)