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

CompletedOBSERVATIONAL
Enrollment

171

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

January 31, 2020

Study Completion Date

June 30, 2020

Conditions
Prostate CancerUrological 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.

"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 feelingie 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 suspectadditional 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"

Trial Locations (1)

69008

Hôpital Edouard Herriot, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT04299997 - Evaluation of the PI-RADS v2.1 Score Using Multiple Readers | Biotech Hunter | Biotech Hunter