Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2020-02-27
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Early Detection Cohort (MRI with DBSI)
* 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
MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
Active Surveillance Cohort (MRI with DBSI)
* 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
MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
Interventions
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MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
Eligibility Criteria
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Inclusion Criteria
* 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
\*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)
18 Years
MALE
No
Sponsors
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American Cancer Society, Inc.
OTHER
The Foundation for Barnes-Jewish Hospital
OTHER
Midwest Stone Institute.
OTHER
National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Joseph Ippolito, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201908215
Identifier Type: -
Identifier Source: org_study_id
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