Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT04420702

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI with DBSI analysis

Study Details

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

Study ID

NCT04420702

Start date

Feb 27, 2020

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

MRI with DBSI analysis

-The procedure will take approximately 1 hour of the participant's time

Primary outcome measure

  • Area under the curve (AUC) comparison from biopsy and DBSI [ Time Frame: Up to 12 weeks ]
  • Receiver operating characteristic (ROC) comparison from biopsy to DBSI [ Time Frame: 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 [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Joseph Ippolito, M.D.

314-362-2925ippolitoj@wustl.edu

Alex Klim

314-747-9781klima@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Joseph Ippolito, M.D.

314-362-2928ippolitoj@wustl.edu

Alex Kim

314-747-9781klima@wustl.edu

Principal Investigator:

Joseph Ippolito, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-14.