Detection Rate of Prostate Cancer in Men Undergoing MRI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostatic Neoplasm

Intervention / Treatment
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* Diagnostic Test: multiparametric MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (previous negative biopsy)<br>Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI | Diagnostic Test: multiparametric MRI<br>* T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging<br>|
| Group B (biopsy naive)<br>Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI | Diagnostic Test: multiparametric MRI<br>* T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCa detection rate | Number of men with positive prostate biopsy over the number of men with a positive MRI | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of MRI | Number of men with negative MRI or positive MRI but negative biopsy who are confirmed as negative for PCa during the follow-up over the total number of subjects considered during the follow-up | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic resonance imaging, prostate biopsy