Diffusion Basis Spectrum Imaging of the Prostate

NCT04420702 | Recruiting FDA Device

• 2 other identifiers: 201908215R01CA258690
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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 (3)

• Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology

  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

Study Arms (2)

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

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Cancer Society, Inc.: collaborator
• The Foundation for Barnes-Jewish Hospital: collaborator
• Midwest Stone Institute.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Joseph Ippolito, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Ippolito, M.D.

CONTACT

314-362-2925; ippolitoj@wustl.edu

Alex Klim

CONTACT

314-747-9781; klima@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: -Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: February 27, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)