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Imaging

DBSI-MRI for Prostate Cancer

N/A
Recruiting
Led By Eric Kim, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial shows that DBSI is a potential non-invasive and accurate imaging test for clinically significant prostate cancer.

Who is the study for?
This trial is for men over 18 who are being checked for prostate cancer either because they have a high PSA level with no previous biopsy, or a high PSA with one negative biopsy. It's also for those already diagnosed and on active surveillance. Men can't join if they have metal implants like pacemakers, cochlear implants, suffer from claustrophobia, can't lie flat for an hour, or had prior prostate surgery.Check my eligibility
What is being tested?
The trial is testing Diffusion Basis Spectrum Imaging (DBSI), which is a non-invasive MRI technique that could improve early detection of clinically significant prostate cancer without the need to take tissue samples.See study design
What are the potential side effects?
Since DBSI involves MRI scanning, there are generally no side effects associated with this procedure itself. However, individuals may experience discomfort from lying still during the scan or anxiety due to the enclosed space of the MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am planning to have a prostate biopsy and have never been diagnosed with prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve (AUC) comparison from biopsy and DBSI
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
Receiver operating characteristic (ROC) comparison from biopsy to DBSI
Secondary outcome measures
Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation
Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology
Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation

Trial Design

2Treatment groups
Experimental Treatment
Group I: Early Detection Cohort (MRI with DBSI)Experimental Treatment1 Intervention
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
Group II: Active Surveillance Cohort (MRI with DBSI)Experimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,255 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,771 Patients Enrolled for Prostate Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
109,955 Total Patients Enrolled
11 Trials studying Prostate Cancer
1,380 Patients Enrolled for Prostate Cancer
Midwest Stone Institute.OTHER
3 Previous Clinical Trials
219 Total Patients Enrolled
1 Trials studying Prostate Cancer
65 Patients Enrolled for Prostate Cancer

Media Library

MRI with DBSI analysis (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT04420702 — N/A
Prostate Cancer Research Study Groups: Early Detection Cohort (MRI with DBSI), Active Surveillance Cohort (MRI with DBSI)
Prostate Cancer Clinical Trial 2023: MRI with DBSI analysis Highlights & Side Effects. Trial Name: NCT04420702 — N/A
MRI with DBSI analysis (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04420702 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment rate for this trial?

"Affirmative. Evidence on clinicaltrials.gov reveals that this study is currently enrolling participants; the trial was uploaded on February 27th 2020 and further adjusted October 3rd 2022. A total of 500 individuals need to be recruited at a single site."

Answered by AI

Are there any vacancies for prospective participants in this medical experiment?

"Yes, according to the details listed on clinicaltrials.gov this trial is actively seeking participants and was first posted on February 27th 2020 with modifications made most recently on October 3rd 2022. Five hundred individuals are required for the study from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diffusion Basis Spectrum Imaging of the Prostate
2020. "Diffusion Basis Spectrum Imaging of the Prostate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04420702.
~213 spots leftby May 2027
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