Detection Rate of Prostate Cancer in Men Undergoing MRI

Status Completed

Clinical Trial Summary

To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.

Clinical Trial Description

The trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of PCa who will undergo MRI. Group A is composed by patients with previous negative biopsy, while group B is composed by men with no previous negative prostate biopsy. To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score >= 3) and biopsy data will be considered. In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04398173
Study type	Observational
Source	Fondazione del Piemonte per l'Oncologia
Contact
Status	Completed
Phase
Start date	November 1, 2014
Completion date	December 31, 2020

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