Diffusion Basis Spectrum Imaging of the Prostate

Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: MRI with DBSI analysis

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric H Kim, M.D.; Phone Number: 314-747-9781; Email: ehkim@wustl.edu
• Study Contact Backup: Name: Alex Klim; Phone Number: 314-747-9781; Email: klima@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Eric H Kim, M.D.; Phone Number: 314-747-9781; Email: ehkim@wustl.edu
      • Contact: Alex Kim; Phone Number: 314-747-9781; Email: klima@wustl.edu
      • Principal Investigator: Eric H Kim, M.D.
      • Sub-Investigator: Sheng-Kwei Song, Ph.D.
      • Sub-Investigator: Joseph E Ippolito, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)
  • Those who cannot lie flat for over 1 hour
• Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Detection Cohort (MRI with DBSI); 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; -The procedure will take approximately 1 hour of the participant's time
Experimental: Active Surveillance Cohort (MRI with DBSI); 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; -The procedure will take approximately 1 hour of the participant's time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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		Up to 12 weeks
Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation		Up to 12 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); American Cancer Society, Inc.; The Foundation for Barnes-Jewish Hospital; Midwest Stone Institute.
• Investigators: Principal Investigator: Eric Kim, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 201908215; R01CA258690 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes