NCT04398173

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	multiparametric MRI	T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging

Timeline

• Start date: 2014-11-01
• Primary completion: 2020-10-31
• Completion: 2020-12-31
• First posted: 2020-05-21
• Last updated: 2021-04-14

Locations

1 site across 1 country: Italy