Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01864135
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2013-04-17
Brief Title:
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging
Status:
COMPLETED
Status Verified Date:
2016-01
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:
IMPROD
Brief Summary:
Prostate cancer has been the most common cancer in men in Finland over the last ten years Prostate-specific antigen PSA plays an important role in screening of prostate cancer However PSA has a limited sensitivity and specificity for prostate cancer detection Commonly the diagnosis of prostate cancer is done by transrectal ultrasonography TRUS guided biopsy Due to the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy As biopsy carries a risk of increase in complications there is an increasing interest in developing more accurate non-invasive imaging modalities
This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 25 ngml andor abnormal digital rectal examination Multiparametric magnetic resonance imaging mpMRI 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
This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 25 ngml andor abnormal digital rectal examination Multiparametric magnetic resonance imaging mpMRI 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:
None
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