Diffusion Basis Spectrum Imaging of the Prostate

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04420702
• Other study ID #: 201908215
• Secondary ID: R01CA258690
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: May 31, 2027

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: Eric H Kim, M.D.
• Phone: 314-747-9781
• Email: ehkim[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Cancer Society, Inc., Midwest Stone Institute., National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation		Up to 12 weeks
Secondary	Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation		Up to 12 weeks

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine