Detection Rate of Prostate Cancer in Men Undergoing MRI

April 13, 2021 updated by: Fondazione del Piemonte per l'Oncologia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with clinical suspicion of PCa, eligible for prostate biopsy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A (previous negative biopsy)
Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI
Diagnostic test: multiparametric MRI
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
Group B (biopsy naive)
Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI
Diagnostic test: multiparametric MRI
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCa detection rate
Time Frame: 24 months
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
Time Frame: 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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProBiopsy-RM19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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