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

NCT04299997 | Completed

• 1 other identifier: MULTI_2020
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urological Cancer

Keywords

multiparametric MRI; ISUP; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.

  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.

  June 2020.

Secondary Outcomes (9)

• 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

Study Arms (1)

171 mpMRIs corresponding to consecutive patients who underwent

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.

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.

Interventions

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. OTHER

1. Ass of targeted suspect lesions On each mpMRI,radiologist will contour lesions that were targeted at subsequent biopsy based on reports. Contours will be disclosed to readers who will assess,for each lesion: * Likert score("gut feeling"ie subjective ass of the likelihood that lesion is clinically significant prostate cancer(5-level scale)) * PI-RADSv2, PI-RADSv2.1 score(by strictly applying the published PI-RADS criteria) * EPE score(ie the likelihood of extraprostatic extension;5-level subjective scale without predefined criteria) * Max diameter 2. Def of add suspect lesions Readers could define suspect"additional targets"(AT);for each AT,they will provide the same criteria. It is expected that, for these suspect AT,at least one score is≥3 3. Ass of lobes Scores of prostate lobes will be automatically calculated based on 2 previous steps of reading. However,in lobes with no suspect lesion,readers could define whether same criteria are1or2,in peripheral zone and transition zone

171 mpMRIs corresponding to consecutive patients who underwent

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with mpMRI and subsequent biopsy between September 2015 and July 2016 (see above).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69008, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: September 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: June 30, 2020
• Last Updated: March 15, 2022

Record last verified: 2022-02

Locations

FR (1)