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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04398173

Enrollment

400

Registered

2020-05-21

Start date

2014-11-01

Completion date

2020-12-31

Last updated

2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasm

Keywords

magnetic resonance imaging, prostate biopsy

Brief 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.

Interventions

DIAGNOSTIC_TESTmultiparametric MRI

T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Negative predictive value of MRI	24 months	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026