Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Study Overview
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Brief Summary
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With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva. The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature. Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.

Official Title
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Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: SonoVue


Participation Criteria
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Eligibility Criteria
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Population: All patients already scheduled for biopsy because of a raised Prostate-Specific Antigen (PSA) and/ or abnormal Digital Rectal Examination (DRE) in the Academic Medical Centre (AMC), excluding patients who do meet the exclusion criteria. Inclusion criteria: age ≥ 18 years signed informed consent Exclusion criteria: Has documented acute prostatitis or urinary tract infections. 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 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 incapable of understanding the language in which the information for the patient is given.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SonoVue<br>Ultrasound Contrast Agent | Drug: SonoVue<br>* 2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.<br>* Other names: MARKETING AUTHORISATION NUMBER(S): EU/1/01/177/002;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification prediction compared with prostate biopsy histology | Prostate cancer detection rate by quantification. Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results? | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification prediction compared with prostate biopsy histology | Prostate cancer Gleason score compared to quantification results Answering the question: Is there a relation between Gleason score and quantification results? | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Enhanced Ultrasound (CEUS), Prostate cancer, Quantification, Prostate biopsies, Transrectal ultrasound (TRUS), Microbubbles