Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02844829
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2016-07-22
Brief Title:
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
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:
IMPROD2_0
Brief Summary:
This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 25 ngml or abnormal digital rectal examination
Anatomical magnetic resonance imaging MRI and diffusion weighted imaging DWI at 3 Tesla T magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer
Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy
Moreover selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer
Anatomical magnetic resonance imaging MRI and diffusion weighted imaging DWI at 3 Tesla T magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer
Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy
Moreover selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer
Detailed Description:
Specific aims of the current study are as follows
i To determine the sensitivity specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
ii To determine the sensitivity specificity and accuracy of selected serum urine and tissue biomarkers for detection of prostate cancer
iii To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRIDWI and selected biomarkers
iv To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy
v To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland VSKK TYKS Turku Finland
i To determine the sensitivity specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
ii To determine the sensitivity specificity and accuracy of selected serum urine and tissue biomarkers for detection of prostate cancer
iii To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRIDWI and selected biomarkers
iv To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy
v To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland VSKK TYKS Turku Finland
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None