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.
Study Type
OBSERVATIONAL
Enrollment
400
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
Candiolo, Turin, Italy
PCa detection rate
Number of men with positive prostate biopsy over the number of men with a positive MRI
Time frame: 24 months
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
Time frame: 24 months
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