Urological Cancer clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT04299997 Completed - Prostate Cancer Clinical Trials

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

MULTI

Start date: September 1, 2019
Phase:
Study type: Observational

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.