Detection Rate of Prostate Cancer in Men Undergoing MRI

Fondazione del Piemonte per l'Oncologia

Status: Completed

Conditions: Prostatic Neoplasm

Treatments: Diagnostic Test: multiparametric MRI

Study type: Observational

Funder types: Other

Identifiers

NCT04398173

ProBiopsy-RM19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

400 participants in 2 patient groups

Group A (previous negative biopsy)

Description:

Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI

Treatment:

Diagnostic Test: multiparametric MRI

Group B (biopsy naive)

Description:

Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI

Treatment:

Diagnostic Test: multiparametric MRI