Diffusion Basis Spectrum Imaging of the Prostate

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: MRI with DBSI analysis

• Registration Number: NCT04420702
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-27
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

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")

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Detection Cohort (MRI with DBSI)	MRI with DBSI analysis	* 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
Active Surveillance Cohort (MRI with DBSI)	MRI with DBSI analysis	* 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

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) comparison from biopsy and DBSI	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.
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
Receiver operating characteristic (ROC) comparison from biopsy to DBSI	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology	Up to 12 weeks	-Only for those patients with a suspicious MRI lesion
Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation	Up to 12 weeks
Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation	Up to 12 weeks

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States