Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer
NCT ID: NCT01764347
Last Updated: 2014-01-28
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2010-11-30
2013-09-30
Brief Summary
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Detailed Description
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I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.
OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (MRI-TRUS fusion image-guided biopsy)
Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
therapeutic conventional surgery
Undergo robotic radical prostatectomy
ultrasound-guided prostate biopsy
Undergo MRI-TRUS fusion image-guided prostate biopsy
magnetic resonance imaging
Undergo MRI-TRUS fusion image-guided prostate biopsy
Interventions
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therapeutic conventional surgery
Undergo robotic radical prostatectomy
ultrasound-guided prostate biopsy
Undergo MRI-TRUS fusion image-guided prostate biopsy
magnetic resonance imaging
Undergo MRI-TRUS fusion image-guided prostate biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
* Subjects must have decided to have their prostate surgically removed
Exclusion Criteria
* Patients with extracapsular extension of their prostate cancer
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Osamu Ukimura
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2012-03037
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-10-6
Identifier Type: -
Identifier Source: org_study_id
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