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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03234556
Other study ID # 4P-16-7
Secondary ID NCI-2017-008904P
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 25, 2017
Est. completion date September 25, 2026

Study information

Verified date April 2024
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy of Prostate
Undergo SR-Bx
Other:
Laboratory Biomarker Analysis
Correlative studies
Diagnostic Test:
Magnetic Resonance Imaging
Undergo MRI
MRI Ultrasound Fusion Guided Biopsy
Undergo MRUS-Bx

Locations

Country Name City State
United States University of Maryland Baltimore Maryland
United States Henry Ford Hospital Vattikuti Urology Institute Detroit Michigan
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Highest Gleason score Will assess the highest Gleason score in magnetic resonance imaging-ultrasound image fusion biopsy and systematic random biopsy. Will evaluated using agreement metrics such as percent agreement, Cohen's kappa (k) statistic and Krippendorff's alpha statistic. Significance will be considered if p < 0.05. Up to 5 years
Primary Biopsy detection rate of clinically significant prostate cancer Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score >= 7 or any Gleason score with core length >= 5 mm or any Gleason score that includes Gleason pattern >= 4 at initial systematic random biopsy. Up to 5 years
Secondary Presence of any of the complications Will be summarized in the complications checklist. Will determine any striking co-morbidities that are present post-biopsy and were absent pre-biopsy within each arm, and next determine if the prevalence of any of these identified post-biopsy morbidities differs between the two arms. For these analyses, regression methods (linear, logistic, multinomial logistic as appropriate for the "dependent" variable being analyzed) will be used. Standard descriptive methods will be used to summarize and display the results. Up to 5 years
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