Clinical trial NCT04420702: Diffusion Basis Spectrum Imaging of the Prostate
Official title: Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: The Foundation for Barnes-Jewish Hospital
name: Midwest Stone Institute.
name: National Cancer Institute (NCI)
First posted: 2020-06-09
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Area under the curve (AUC) comparison from biopsy and DBSI
timeFrame: Up to 12 weeks
measure: Receiver operating characteristic (ROC) comparison from biopsy to DBSI
timeFrame: Up to 12 weeks
measure: 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
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology
timeFrame: Up to 12 weeks
measure: Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation
timeFrame: Up to 12 weeks
measure: Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joseph Ippolito, M.D.
role: PRINCIPAL_INVESTIGATOR
References: