Diffusion Basis Spectrum Imaging of the Prostate | NCT04420702

NCT04420702

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
R01CA258690	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
American Cancer Society, Inc.	OTHER
The Foundation for Barnes-Jewish Hospital	OTHER
Midwest Stone Institute.	OTHER
National Cancer Institute (NCI)

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early Detection Cohort (MRI with DBSI)	Experimental	Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy Standard of care prostate biopsy will be performed within 12 weeks of MRI Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging	Device: MRI with DBSI analysis
Active Surveillance Cohort (MRI with DBSI)	Experimental	Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy Standard of care prostate biopsy will be performed within 12 weeks of MRI Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging	Device: MRI with DBSI analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI with DBSI analysis	Device	-The procedure will take approximately 1 hour of the participant's time	Active Surveillance Cohort (MRI with DBSI) Early Detection Cohort (MRI with DBSI)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve (AUC) comparison from biopsy and DBSI	As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.	Up to 12 weeks
Receiver operating characteristic (ROC) comparison from biopsy to DBSI	As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.	Up to 12 weeks
Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector		Up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology	-Only for those patients with a suspicious MRI lesion	Up to 12 weeks
Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Joseph Ippolito, M.D.	Contact	314-362-2925		ippolitoj@wustl.edu
Alex Klim	Contact	314-747-9781		klima@wustl.edu