Diffusion Basis Spectrum Imaging of the Prostate

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

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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