SonoVue Guided Prostate Biopsy

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Contrast-enhanced ultrasound guided biopsy
* Procedure: ultrasound guided systematic biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SonoVue guided biopsy<br> | Drug: Contrast-enhanced ultrasound guided biopsy<br>* 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<br>* Other names: SonoVue guided biopsy;|
| Other: Systematic biopsy<br> | Procedure: ultrasound guided systematic biopsy<br>* Current practice of ultrasound guided systematic biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Cancer, Biopsy, Guided, Contrast, Enhanced, SonoVue, Suspicion of prostate cancer