Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer

NCT ID: NCT03693703

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 391 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2020-03-31

Brief Summary

To compare the detection rate of biparametric (bp) magnetic resonance imaging (MRI) for clinically significant prostate cancer (PCa) with that of multiparametric (mp)-MRI, in biopsy-naïve patients. Today, bp-MRI is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-MRI. Its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time.

Secondary objectives will be:

• to assess specificity of a blood test based on microRNA (miR) score in biopsy-naïve patients, using pathological assessment after MR-guided biopsy as reference standard. If specificity of the miR score is higher than that of PSA, then fewer patients will undergo unnecessary MRI, thus increasing the efficiency of the diagnostic pipeline for PCa;
• to develop a clinical decision support system (CDSS) based on MRI and circulating miR evaluation, to stratify patients according to their risk of PCa progression, using pathological assessment after prostatectomy as reference standard. Patients will be stratified into two classes of risk: i) low-risk PCa, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk PCa in which patients should undergo radical treatment (i.e. surgery or radiation therapy).

Detailed Description

The trial is a prospective, randomized, two-arms study with a 2:1 ratio. Subjects meeting the inclusion criteria will be randomized either into the bp-MRI group (arm A), or the mp-MRI one (arm B). All subjects will perform blood sampling in EDTA tubes before undergoing imaging session. Plasma will be isolated within 1 hour from sampling, with a double round centrifugation, aliquoted and stored at -80°C before undergoing miR analysis.

MRI will be performed with a 1.5 T using axial T2w and diffusion-weighted imaging for subjects in arm A with no endorectal coil and no intravenous contrast agent. Men randomized in arm B will undergo MRI with T2w in the three acquisition planes, diffusion-weighted and dynamic contrast-enhanced imaging usign endorectal coil.

Random biopsy will be performed in subjects with no suspicious regions for PCa found on MRI. Men with suspicious regions on MRI will be invited to a targeted or in-bore biopsy.

Conditions

Prostatic Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

bi-parametric MRI

Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)

Group Type: EXPERIMENTAL

bi-parametric MRI

Intervention Type: DIAGNOSTIC_TEST

Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration

multi-parametric MRI

Patients will undergo multiparametric MRI including morphological study (T2- and T1-weighted imaging) and functional acquisitions (diffusion-weighted and dynamic contrast-enhanced imaging)

Group Type: ACTIVE_COMPARATOR

multi-parametric MRI

Intervention Type: DIAGNOSTIC_TEST

T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration

Interventions

bi-parametric MRI

Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration

Intervention Type: DIAGNOSTIC_TEST

multi-parametric MRI

T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• age <= 75 years
• PSA <= 15 ng/ml
• no previous prostate biopsy
• negative digital rectal examination
• signed infomed conset

Exclusion Criteria

• known prostate cancer diagnosis
• previous prostate biopsy or surgery
• contraindication to MRI
• non-cooperative subjects

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Filippo Russo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia

Locations

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, Italy

Countries

Italy

References

Russo F, Mazzetti S, Regge D, Ambrosini I, Giannini V, Manfredi M, De Luca S, Bollito E, Porpiglia F. Diagnostic Accuracy of Single-plane Biparametric and Multiparametric Magnetic Resonance Imaging in Prostate Cancer: A Randomized Noninferiority Trial in Biopsy-naive Men. Eur Urol Oncol. 2021 Dec;4(6):855-862. doi: 10.1016/j.euo.2021.03.007. Epub 2021 Apr 21.

Reference Type: DERIVED

PMID: 33893066 (View on PubMed)

Other Identifiers

bpMRscr16

Identifier Type: -

Identifier Source: org_study_id