Diffusion Basis Spectrum Imaging of the Prostate

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: MRI with DBSI analysis


Participation Criteria
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Eligibility Criteria
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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 Those who cannot lie flat for over 1 hour Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Detection Cohort (MRI with DBSI)<br>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 | Device: MRI with DBSI analysis<br>* -The procedure will take approximately 1 hour of the participant's time<br>|
| Experimental: Active Surveillance Cohort (MRI with DBSI)<br>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 | Device: MRI with DBSI analysis<br>* -The procedure will take approximately 1 hour of the participant's time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) comparison from biopsy and DBSI | 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. | Up to 12 weeks | 
| Receiver operating characteristic (ROC) comparison from biopsy to DBSI | 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. | 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 |  | Up to 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer