Clinical trial NCT04299997: Evaluation of the PI-RADS v2.1 Score Using Multiple Readers
Official title: Accuracy of the PI-RADS v2.1 Score for Characterizing ISUP ≥2 Prostate Cancers on Multiparametric MRI: a Multiple Reader Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Urological Cancer
Keywords: multiparametric MRI
ISUP
Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 171
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with mpMRI and subsequent biopsy between September 2015 and July 2016 (see above).

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.


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

Primary outcomes:
measure: AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.
timeFrame: June 2020.
Secondary outcomes:
measure: AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at biopsy, at the lesionlobe and patient levels
timeFrame: June 2020
measure: Inter-reader concordance of the PI-RADS v2.1 score, at lesion, lobe and patient levels
timeFrame: June 2020
measure: AUC of the PI-RADS v2 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion, lobe and patient levels
timeFrame: June 2020
measure: Inter-reader concordance of the PI-RADS v2 score at lesion, lobe and patient levels
timeFrame: June 2020
measure: AUC of the Likert score for predicting ISUP ≥2 cancer at biopsy at the lesion, lobe and patient levels
timeFrame: June 2020
measure: Inter-reader concordance of the Likert score at lesion, lobe and patient levels
timeFrame: June 2020
measure: Analysis of the diagnostic value of the PI-RADS v2.1 components
timeFrame: June 2020
measure: Added value of the Likert score
timeFrame: June 2020
measure: Description of patients with negative initial biopsy and who were diagnosed with ISUP ≥2 cancer after 3 years of follow-up
timeFrame: June 2020
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References: