Prostate Cancer
Conditions
Keywords
Prostate, Cancer, Biopsy, Guided, Contrast, Enhanced, SonoVue, Suspicion of prostate cancer
Brief summary
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.
Interventions
DRUGContrast-enhanced ultrasound guided biopsy
One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part One to four bolus (each 2.4mL) of SonoVue per patient in the main part
PROCEDUREultrasound guided systematic biopsy
Current practice of ultrasound guided systematic biopsy
Sponsors
Bracco Imaging S.p.A.
Bracco Diagnostics, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure. | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy | Day 1 |
| Assessment of potentiality of SonoVue guided biopsy to increase % of positive bioptic cores compared to % of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures. | Day 1 |
| Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores. | Day 1 |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed