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Diffusion Basis Spectrum Imaging of the Prostate

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI with DBSI analysis
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years of age and willing and able to provide informed consent.
  • Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")

  • Including those men with:

    • an elevated PSA and no prior biopsy
    • an elevated PSA and a negative prior biopsy
  • Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")

Exclusion Criteria:

  • Patients with any clinical contraindication to MRI

    *Including but not limited to:

    • Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
    • Those with cochlear implants
    • Those with claustrophobia
    • Those who cannot lie flat for over 1 hour
  • Patients with prior prostate surgery (e.g. radical prostatectomy, TURP)

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Detection Cohort (MRI with DBSI)

Active Surveillance Cohort (MRI with DBSI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology
-Only for those patients with a suspicious MRI lesion
Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation
Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation

Full Information

First Posted
June 3, 2020
Last Updated
August 31, 2023
Sponsor
Washington University School of Medicine
Collaborators
American Cancer Society, Inc., The Foundation for Barnes-Jewish Hospital, Midwest Stone Institute., National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04420702
Brief Title
Diffusion Basis Spectrum Imaging of the Prostate
Official Title
Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
American Cancer Society, Inc., The Foundation for Barnes-Jewish Hospital, Midwest Stone Institute., National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
-Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Detection Cohort (MRI with DBSI)
Arm Type
Experimental
Arm Description
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
Arm Title
Active Surveillance Cohort (MRI with DBSI)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MRI with DBSI analysis
Intervention Description
-The procedure will take approximately 1 hour of the participant's time
Primary Outcome Measure Information:
Title
Area under the curve (AUC) comparison from biopsy and DBSI
Description
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.
Time Frame
Up to 12 weeks
Title
Receiver operating characteristic (ROC) comparison from biopsy to DBSI
Description
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.
Time Frame
Up to 12 weeks
Title
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
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology
Description
-Only for those patients with a suspicious MRI lesion
Time Frame
Up to 12 weeks
Title
Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation
Time Frame
Up to 12 weeks
Title
Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation
Time Frame
Up to 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years of age and willing and able to provide informed consent. Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort") Including those men with: an elevated PSA and no prior biopsy an elevated PSA and a negative prior biopsy Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort") Exclusion Criteria: Patients with any clinical contraindication to MRI *Including but not limited to: Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators Those with cochlear implants Those with claustrophobia Those who cannot lie flat for over 1 hour Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric H Kim, M.D.
Phone
314-747-9781
Email
ehkim@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Klim
Phone
314-747-9781
Email
klima@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Kim, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric H Kim, M.D.
Phone
314-747-9781
Email
ehkim@wustl.edu
First Name & Middle Initial & Last Name & Degree
Alex Kim
Phone
314-747-9781
Email
klima@wustl.edu
First Name & Middle Initial & Last Name & Degree
Eric H Kim, M.D.
First Name & Middle Initial & Last Name & Degree
Sheng-Kwei Song, Ph.D.
First Name & Middle Initial & Last Name & Degree
Joseph E Ippolito, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Diffusion Basis Spectrum Imaging of the Prostate

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