Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02241122
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2014-09-12
Brief Title:
MRI and Biomarkers in Prostate Cancer
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers Multi-institutional Study
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Multi-IMPROD
Brief Summary:
Prostate cancer has been the most common neoplastic disease 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 Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy As biopsy carries a significant risk of complications there is an increasing interest in developing more accurate non-invasive imaging modalities
This prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 25 ngml andor abnormal digital rectal examination Anatomical magnetic resonance imaging MRI and diffusion weighted imaging DWI at 153 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 prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 25 ngml andor abnormal digital rectal examination Anatomical magnetic resonance imaging MRI and diffusion weighted imaging DWI at 153 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