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NCT Number: NCT04420702

Diffusion Basis Spectrum Imaging of the Prostate

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Alex Kim

CONTACT

[email protected]

314-747-9781

Joseph Ippolito, M.D.

CONTACT

[email protected]

314-362-2928

Joseph Ippolito, M.D.

PRINCIPAL_INVESTIGATOR

Michael H Johnson, M.D.

SUB_INVESTIGATOR

Sheng-Kwei Song, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI with DBSI analysis

Device

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

Primary outcomes

  1. Area under the curve (AUC) comparison from biopsy and DBSI

    Time frame: Up to 12 weeks

    • 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.

  2. Receiver operating characteristic (ROC) comparison from biopsy to DBSI

    Time frame: Up to 12 weeks

    • 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.

  3. 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 outcomes

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

    Time frame: Up to 12 weeks

    -Only for those patients with a suspicious MRI lesion

  2. Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation

    Time frame: Up to 12 weeks

  3. Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation

    Time frame: Up to 12 weeks

  4. Compare DBSI with the advanced restriction spectrum imaging (RSI)

    Time frame: Up to 12 weeks

    The investigators will perform DBSI modeling on RSI data obtained from UCSD and the results from both DBSI and RSI protocols will be compared and analyzed to determine a strategy for improving the DBSI protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Klim

CONTACT

[email protected]

314-747-9781

Joseph Ippolito, M.D.

CONTACT

[email protected]

314-362-2925

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2020
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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