Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01990521
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2013-11-15
Brief Title:
Prostate Screening Study Using MRI in BRCA Carriers
Sponsor:
Toronto Sunnybrook Regional Cancer Centre
Organization:
Toronto Sunnybrook Regional Cancer Centre
Study Overview
Official Title:
Screening Male BRCA Mutation Carriers Effectiveness of Multispectral 3T Magnetic Resonance Imaging
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset aggressive prostate cancer compared to men in the general population
Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination DRE the same as with men in the general population
This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening PSA DRE It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease
Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination DRE the same as with men in the general population
This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening PSA DRE It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease
Detailed Description:
To determine the value of using Multispectral 3T MRI MS3TMRI for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status with no prior prostate cancer diagnosis independent of baseline PSA levels
Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels
To evaluate the accuracy of tumor targeting based on MRI and ultrasound US tumor co-localization To evaluate the sensitivity specificity PPV NPV and accuracy of an automated computer aided diagnosis method CAD applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer
Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels
To evaluate the accuracy of tumor targeting based on MRI and ultrasound US tumor co-localization To evaluate the sensitivity specificity PPV NPV and accuracy of an automated computer aided diagnosis method CAD applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer
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