Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242060
Status:
COMPLETED
Last Update Posted:
2010-07-15
First Post:
2005-10-18
Brief Title:
Functional and Morphologic MRI in the Detection of Prostate Cancer in Patients With Prior Negative Biopsy
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
The Utility of Functional and Morphologic MRI in the Detection of Prostate Cancer for Patients With Elevated PSA and Prior Negative Biopsy
Status:
COMPLETED
Status Verified Date:
2010-07
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:
Prostate specific antigen PSA and digital rectal exam DRE are used to screen for prostate cancer Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy TRUS-Bx There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer The purpose of this study is to determine if MRI using an endorectal coil and advanced MRI methods called H1 MR Spectroscopy MRS and Dynamic MR Perfusion Imaging dMRI can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland 100 men currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study
Detailed Description:
Prostate specific antigen PSA and digital rectal exam DRE are used to screen for prostate cancer Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy TRUS-Bx There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer The purpose of this study is to determine if MRI using an endorectal coil and advanced MRI methods called H1 MR Spectroscopy MRS and Dynamic MR Perfusion Imaging dMRI can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland 100 men currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study
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