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

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Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

March 28, 2018

Estimated Primary Completion Date

December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Detection rate of bi-parametric MRI, and of mp-MRI in men at risk for PCa and with no previous prostate biopsy[ Time Frame: 3 months ]

Sensitivity, specificity, PPV and NPV will be measured

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: bi-parametric MRI
Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration
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

Study Arms

Experimental: bi-parametric MRI
Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)
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)

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

350

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2020

Estimated Primary Completion Date

December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Italy

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Fondazione del Piemonte per l'Oncologia

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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