Accuracy of the PI-RADS v2.1 Score for Characterizing ISUP ≥2 Prostate Cancers on Multiparametric MRI: a Multiple Reader Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI interpretation. It is a 5-level score that assesses the likelihood that suspicious focal prostatic lesions seen on mpMRI are clinically significant prostate cancers. Despite the use of semi-objective criteria for each category of the score, the inter-reader reproducibility of the first two versions (PI-RADS v1 launched in 2012 and PI-RADS v2 launched in 2015) was moderate at best, even for experienced readers. The last version (PI-RADS v2.1) has been launched in March 2019 in an effort to improve the inter-reader reproducibility. This version has not been evaluated yet.
The purpose of our study is to evaluate the accuracy and inter-reader reproducibility of the PI-RADS v2.1 score on a large set of 171 prostate MRIs using 21 readers of varying experience.
Twenty-one readers (14 seniors and 7 juniors) from 9 different institutions and with varying experience in prostate mpMRI accepted to participate to the study.
Reader will assess the dataset independently and will be blinded to the other readers' results. They also be blinded to clinical and biochemical data.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prostate mpMRI and biopsy performed at our institution
- •Performed between September 2015 and July 2016
- •No history of prostate cancer at the time of the mpMRI
Exclusion Criteria
- •Patients who already had treatment for prostate cancer
- •Patients under Active Surveillance
Outcomes
Primary Outcomes
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.
Time Frame: June 2020.
Analysis at the lesion level will be favored to get an evaluation of the influence of experience of readers scoring the exact same set of lesions.
Secondary Outcomes
- AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at biopsy, at the lesionlobe and patient levels(June 2020)
- Inter-reader concordance of the PI-RADS v2.1 score, at lesion, lobe and patient levels(June 2020)
- AUC of the PI-RADS v2 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion, lobe and patient levels(June 2020)
- Inter-reader concordance of the PI-RADS v2 score at lesion, lobe and patient levels(June 2020)
- AUC of the Likert score for predicting ISUP ≥2 cancer at biopsy at the lesion, lobe and patient levels(June 2020)
- Inter-reader concordance of the Likert score at lesion, lobe and patient levels(June 2020)
- Analysis of the diagnostic value of the PI-RADS v2.1 components(June 2020)
- Added value of the Likert score(June 2020)
- Description of patients with negative initial biopsy and who were diagnosed with ISUP ≥2 cancer after 3 years of follow-up(June 2020)