Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03693703
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2018-10-01
Brief Title:
Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer
Sponsor:
Fondazione del Piemonte per lOncologia
Organization:
Fondazione del Piemonte per lOncologia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie active surveillance and ii mediumhigh-risk PCa in which patients should undergo radical treatment ie surgery or radiation therapy
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 ie active surveillance and ii mediumhigh-risk PCa in which patients should undergo radical treatment ie surgery or radiation therapy
Detailed Description:
The trial is a prospective randomized two-arms study with a 21 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 -80C before undergoing miR analysis
MRI will be performed with a 15 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
MRI will be performed with a 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None