Detection Rate of Prostate Cancer in Men Undergoing MRI

Completed

• Conditions: Prostatic Neoplasm
• Interventions: Diagnostic Test: multiparametric MRI

• Registration Number: NCT04398173
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

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.

Study Timeline

• Study Start: 2014-11-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 400

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

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Exclusion Criteria

• previous history of PCa

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B (biopsy naive)	multiparametric MRI	Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI
Group A (previous negative biopsy)	multiparametric MRI	Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI

Primary Outcome Measures

Name	Time	Method
PCa detection rate	24 months	Number of men with positive prostate biopsy over the number of men with a positive MRI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute; 🇮🇹 Candiolo, Turin, Italy