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

Cost-efficacy of a Preliminary Diagnostic Program Using Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer and no Previous Prostate Biopsy: a Prospective Randomized Clinical Study Comparing Multiparametric and Bi-parametric Magnetic Resonance Imaging Results

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Diagnostic test: bi-parametric MRI; Diagnostic test: multi-parametric MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bi-parametric MRI; Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)	Diagnostic test: bi-parametric MRI; Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration
Active Comparator: 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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of bi-parametric MRI, and of mp-MRI in men at risk for PCa and with no previous prostate biopsy	Sensitivity, specificity, PPV and NPV will be measured	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dimension of lesions identified at bp-MRI/mp-MRI;	Mean lesion dimension will be assessed in each study arm	2 weeks
The proportion of clinically significant PCa identified at bp-MRI;	The number of clinically significant PCa over the total number of PCa detected at bp-MRI will be measured	2 weeks
Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients		3 months

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Investigators: Principal Investigator: Filippo Russo, MD, Fondazione del Piemonte per l'Oncologia

Publications and helpful links

General Publications

• 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-naïve Men. Eur Urol Oncol. 2021 Dec;4(6):855-862. doi: 10.1016/j.euo.2021.03.007. Epub 2021 Apr 21.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; microRNA; prostate biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: bpMRscr16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No