Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer
Primary Purpose
Prostatic Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
bi-parametric MRI
multi-parametric MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasm focused on measuring magnetic resonance imaging, prostate biopsy, microRNA
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
Sites / Locations
- Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bi-parametric MRI
multi-parametric MRI
Arm Description
Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)
Patients will undergo multiparametric MRI including morphological study (T2- and T1-weighted imaging) and functional acquisitions (diffusion-weighted and dynamic contrast-enhanced imaging)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Dimension of lesions identified at bp-MRI/mp-MRI;
Mean lesion dimension will be assessed in each study arm
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
Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients
Full Information
NCT ID
NCT03693703
First Posted
October 1, 2018
Last Updated
August 11, 2020
Sponsor
Fondazione del Piemonte per l'Oncologia
1. Study Identification
Unique Protocol Identification Number
NCT03693703
Brief Title
Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione del Piemonte per l'Oncologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
Keywords
magnetic resonance imaging, prostate biopsy, microRNA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
391 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bi-parametric MRI
Arm Type
Experimental
Arm Description
Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)
Arm Title
multi-parametric MRI
Arm Type
Active Comparator
Arm Description
Patients will undergo multiparametric MRI including morphological study (T2- and T1-weighted imaging) and functional acquisitions (diffusion-weighted and dynamic contrast-enhanced imaging)
Intervention Type
Diagnostic Test
Intervention Name(s)
bi-parametric MRI
Intervention Description
Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration
Intervention Type
Diagnostic Test
Intervention Name(s)
multi-parametric MRI
Intervention Description
T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration
Primary Outcome Measure Information:
Title
Detection rate of bi-parametric MRI, and of mp-MRI in men at risk for PCa and with no previous prostate biopsy
Description
Sensitivity, specificity, PPV and NPV will be measured
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Dimension of lesions identified at bp-MRI/mp-MRI;
Description
Mean lesion dimension will be assessed in each study arm
Time Frame
2 weeks
Title
The proportion of clinically significant PCa identified at bp-MRI;
Description
The number of clinically significant PCa over the total number of PCa detected at bp-MRI will be measured
Time Frame
2 weeks
Title
Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Russo, MD
Organizational Affiliation
Fondazione del Piemonte per l'Oncologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
City
Candiolo
State/Province
Turin
ZIP/Postal Code
10060
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
33893066
Citation
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.
Results Reference
derived
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Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer
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