NCT03615131

Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer

Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators 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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI-TRUS fusion prostate biopsy	First an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-30
• Completion: 2017-03-30
• First posted: 2018-08-03
• Last updated: 2018-08-22

Locations

1 site across 1 country: Switzerland