Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.

Detailed Description
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The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference. The analysis will include the detection of all prostate cancer lesions as well as the detection of significant prostate cancer lesions. With this approach it is possible to calculate the sensitivity, specificity, negative predictive value, positive predictive value and overall accuracy of the correct detection of prostate cancer in the prostate. These results are of importance when the ExactVu ultrasound scanner is to be used later for prostate cancer diagnosis using targeted biopsies.

Official Title
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Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: HR-TRUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men > 35 years age and <80 years of age diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy staging by standard procedures show localized disease (<cT4) PSA < 50ng/ml Access to the rectum for trans rectal ultrasound Patient affiliated to the ''National security'' regimen or beneficiary of this regimen Signed written informed consent prior to any screening procedures being performed Exclusion Criteria: Patient with absence of diagnosis of prostate cancer Patient with metastatic prostate cancer Patient with rectal amputation Patient with contraindications for MRI Patient in urgency situation, adult under legal protection, or unable to give his consent.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HR-TRUS<br>HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer | Device: HR-TRUS<br>* Medical procedures to be performed in the study consist of subject preparation and prostate imaging. The HR-TRUS exam will be done with a transrectal probe either the day before surgery, or in the OR right before surgery. The exam will be done in the same manner as during a regular transrectal ultrasound exam and no invasive procedures will be associated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of high resolution ultrasound | rate of adequately identified (positive or negative) lesions of prostate cancer | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer. | sensitivity, specificity, negative and positive predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer. | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | 
| Morphology of lesions not detected by high-resolution ultrasound | Volume and grade of lesions not detected by high-resolution ultrasound | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | 
| Localization of lesions not detected by high-resolution ultrasound | Location of lesions not detected by high-resolution ultrasound | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | 
| Extra-prostatic extensions detected by high-resolution ultra-sound | Extra-prostatic extensions and seminal vesicle invasions detected by high-resolution ultra-sound in positive and negative sectors | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatectomy, multiparametric MRI, ExactVu ultrasound scanner