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NCT04398173 Clinical Trial

Detection Rate of Prostate Cancer in Men Undergoing MRI

Prostatic Neoplasm Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04398173
Other study ID # ProBiopsy-RM19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2014
Est. completion date December 31, 2020

Study information
Verified date April 2021
Source Fondazione del Piemonte per l'Oncologia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• multiparametric MRI
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging

Locations
Country Name City State
Italy Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute Candiolo Turin

Sponsors (1)
Lead Sponsor Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary PCa detection rate Number of men with positive prostate biopsy over the number of men with a positive MRI 24 months
Secondary 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
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