Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02388126
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2015-03-08
Brief Title:
Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
None
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:
PROMANEG
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 While as many as 47 of the ultra-sound guided biopsies may be false negative and biopsies carry 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 previous negative biopsies and clinical suspicion of prostate cancer due to serum level of PSA higher than 25 ngml or abnormal digital rectal examination DRE or patients in active surveillance due to low risk prostate carcinoma 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 In addition to routine 12-core TRUS biopsies targeted TRUS guided biopsy based on MRI findings will be performed
This study will enroll 150 men with previous negative biopsies and clinical suspicion of prostate cancer due to serum level of PSA higher than 25 ngml or abnormal digital rectal examination DRE or patients in active surveillance due to low risk prostate carcinoma 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 In addition to routine 12-core TRUS biopsies targeted TRUS guided biopsy based on MRI findings will be performed
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