BR55 in Prostate Cancer: an Exploratory Clinical Trial

Study Overview
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Brief Summary
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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).

Official Title
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Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: BR55


Participation Criteria
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Eligibility Criteria
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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;

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BR55<br> | Drug: BR55<br>* One to two bolus (2nd bolus optional) of BR55 per patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BR55 sensitivity assessment | Assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BR55 specificity assessment | Evaluate the specificity of BR55 targeting for prostate cancer relative to normal prostate gland on the basis of a visual score in comparison with routine histopathology analysis and IHC assessment of VEGFR2 expression in tissue specimens. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Ultrasound molecular imaging, Contrast agent, BR55, VEGFR2