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OpenTrials
Completed

NCT Number: NCT04398173

Detection Rate of Prostate Cancer in Men Undergoing MRI

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.

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Key information

Conditions

Prostatic Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, 10060, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multiparametric MRI

Diagnostic Test

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

Primary outcomes

  1. PCa detection rate

    Time frame: 24 months

    Number of men with positive prostate biopsy over the number of men with a positive MRI

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 21, 2020
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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