Prospective evaluation of an artificial intelligence (AI)-assisted, software-based (Quantib®Prostate) reporting of multiparametric magnetic resonance imaging (MRI) in the context of MRI/ultrasound fusion biopsies of the prostate

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00033322
• Lead Sponsor: Vivantes Klinikum Am Urban

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-08-31
• Study Start: 2023-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 262

Inclusion Criteria

patients with an mpMRI of the prostate (T2, DWI and, if applicable, DCE sequences) who are suitable for evaluation with the Quantib®Prostate AI software and who subsequently undergo an MRI/US fusion biopsy of the prostate with needle tracking at the urology clinic of Vivantes Klinikum Am Urban.

Exclusion Criteria

- inadequate image quality of the mpMRI
- missing mpMRI before biopsy
- missing mpMRI sequences for analysis by the AI software
- premature termination of the prostate biopsy or insufficient histological material for subsequent analyses

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Calculation of the PCa detection rate by an MRI/ultrasound fusion biopsy of the prostate in suspicious lesions (ROI) of the mpMRI detected by the AI software (Quantib®Prostate)<br><br>Calculation of the PCa detection rate by an MRI/ultrasound fusion biopsy of the prostate in suspicious lesions of the mpMRI described by the radiological PI-RADS reporting (index lesion)

Secondary Outcome Measures

Name	Time	Method
- correspondence of the localisation of index lesions in the mpMRI with the ROIs in the AI software<br>- determination of the rate of additionally detected prostate cancer in ROIs of the AI software without detection in the radiological reporting<br>- comparison of the prostate volumes determined by ultrasound, MRI and AI software, as well as the PSA densities based on the prostate volume