Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573736
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway a Multi-centered Validation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway a Multi-centered Validation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S3M-MRI
Brief Summary:
Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of prostate cancer will be included Blood sample will be drawn on the day of MRI or immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3 Specifically the Stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results The patients will not receive the results of the Stockholm3 assay A Stockholm3 score will be reported for each patient
The primary aim is to show superior specificity of Stockholm3 at different thresholds for MRI selection compared to PSA at different thresholds Ie the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI
Additional aims
1 To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA The proportion of men with a positive Stockholm3 test at different thresholds or a positive PSA test at different thresholds among those diagnosed with csPC will be calculated
2 To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection
The primary aim is to show superior specificity of Stockholm3 at different thresholds for MRI selection compared to PSA at different thresholds Ie the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI
Additional aims
1 To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA The proportion of men with a positive Stockholm3 test at different thresholds or a positive PSA test at different thresholds among those diagnosed with csPC will be calculated
2 To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection
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