Detection Rate of Prostate Cancer in Men Undergoing MRI

A Retrospective Observational Study to Assess Prostate Cancer Detection Rate in Men Undergoing Magnetic Resonance Imaging: Comparison Between Subjects With Previous Negative Biopsy and Biopsy Naive Men

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.

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.

Inclusion Criteria:

• age 50 and life expectancy greater than 10 years
• PSA values persistently greater than 4 ng/ml
• multiparametric MRI of the prostate between nov-2014 and nov-2016
• MRI with endorectal coil

Exclusion Criteria:

• previous history of PCa