Diffusion Basis Spectrum Imaging of the Prostate

Clinicaltrials.gov ID: NCT04420702
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 500

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Joseph Ippolito, M.D.

Eligibility Criteria

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)

Study Plan

Early Detection Cohort (MRI with DBSI)

EXPERIMENTAL

* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsyn* Standard of care prostate biopsy will be performed within 12 weeks of MRIn* 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

    Description:

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

Active Surveillance Cohort (MRI with DBSI)

EXPERIMENTAL

* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsyn* Standard of care prostate biopsy will be performed within 12 weeks of MRIn* 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

    Description:

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

Outcome Measures

Primary Outcome Measures

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

Time Frame: Up to 12 weeks

Receiver operating characteristic (ROC) comparison from biopsy to DBSI

Time Frame: 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

Time Frame: Up to 12 weeks

Secondary Outcome Measures

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

Time Frame: Up to 12 weeks

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

Time Frame: Up to 12 weeks

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

Time Frame: Up to 12 weeks

Timeline

  • Last Updated
    July 16, 2024
  • Start Date
    June 9, 2020
  • Today
    January 22, 2025
  • Completion Date ( Estimated )
    May 31, 2027

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