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Diffusion Basis Spectrum Imaging of the Prostate

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The Washington University

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Device: MRI with DBSI analysis

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04420702
201908215
R01CA258690 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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 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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

Early Detection Cohort (MRI with DBSI)
Experimental group
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
Treatment:
Device: MRI with DBSI analysis
Active Surveillance Cohort (MRI with DBSI)
Experimental group
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
Treatment:
Device: MRI with DBSI analysis

Trial contacts and locations

1

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Central trial contact

Joseph Ippolito, M.D.; Alex Klim

Data sourced from clinicaltrials.gov

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