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Clinical Trial Summary

We investigated whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, we investigated whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, our study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.


Clinical Trial Description

Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. We investigated whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, we investigated whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, our study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03615131
Study type Observational
Source Kantonsspital Winterthur KSW
Contact
Status Completed
Phase
Start date September 1, 2015
Completion date March 30, 2017

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