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

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

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 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.

Inclusion Criteria:

1. men > 35 years age and <80 years of age
2. diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
3. staging by standard procedures show localized disease (<cT4)
4. PSA < 50ng/ml
5. Access to the rectum for trans rectal ultrasound
6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
7. Signed written informed consent prior to any screening procedures being performed

Exclusion Criteria:

1. Patient with absence of diagnosis of prostate cancer
2. Patient with metastatic prostate cancer
3. Patient with rectal amputation
4. Patient with contraindications for MRI
5. Patient in urgency situation, adult under legal protection, or unable to give his consent.