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

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Trial Identification

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

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

Study ID: NCT03679819

Conditions

Prostate Cancer

Interventions

HR-TRUS

Study Description

Brief Summary: 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: 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.