Evaluation of the PI-RADS v2.1 Score Using Multiple Readers

Completed

• Conditions: Urological Cancer; Prostate Cancer
• Interventions: Other: Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.

• Registration Number: NCT04299997
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-01-31
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Study Completion: 2020-06-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 171

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

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Exclusion Criteria

• Patients who already had treatment for prostate cancer
• Patients under Active Surveillance

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
171 mpMRIs corresponding to consecutive patients who underwent	Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.	The mpMRIs were performed on a 1.5T GE MR unit or on a 3T GE or Philips MR units. All mpMRIs included T2-weighted imaging, diffusion-weighted imaging (maximal b value: 2000 s/mm²) and dynamic contrast-enhanced imaging.

Primary Outcome Measures

Name	Time	Method
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.	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 Outcome Measures

Name	Time	Method
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	The PI-RADS v2.1 score is made by several components who have different diagnostic weights. The added value of the following components will be assessed: * Lesions DCE+: do they correspond more often to ISUP ≥2 cancers than DCE- lesions?; * Lesions with DWI score of 4: is a size of 10-14 mm more predictive of ISUP ≥2 cancers than a size \< 10 mm?; * Lesions with a T2w score of 2 and a DWI score of 4 in the PI-RADS v2.1 score: what is the proportion of ISUP ≥2 cancers?
Added value of the Likert score	June 2020	- This part will be only exploratory and narrative. It is aimed at evaluating, at least for the most experienced readers, if there are circumstances in which the Likert score (i.e. "gut feeling") is more predictive of ISUP ≥2 cancers than the PI-RADS v2.1 score.
Description of patients with negative initial biopsy and who were diagnosed with ISUP ≥2 cancer after 3 years of follow-up	June 2020	Because targeted and systematic biopsy may miss cancer foci, follow-up data will be retrieved from the patients' files. Patients with no follow-up data within the last year will be reached by phone to update their follow-up.The patients with initial biopsy showing no cancer or ISUP 1 cancer and who were subsequently diagnosed with ISUP ≥2 cancers during the 3-year follow-up will be reported and described.

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France