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NCT03234556 · ClinicalTrials.gov registry record · NA
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
A NA study of Health Status Unknown and Elevated PSA, sponsored by University of Southern California.
- Active
- Registry status
- NA
- Development phase
- 288
- Enrollment target
- 4
- Study locations
NCT03234556: Active NA study of Health Status Unknown and Elevated PSA, sponsored by University of Southern California.
NCT03234556 is a NA study of Health Status Unknown and Elevated PSA that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 288 participants, below the 1,280-participant average among 6 other Health Status Unknown trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03234556, a NA study of Health Status Unknown and Elevated PSA, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 288 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Biopsy of Prostate
- DIAGNOSTIC_TEST Magnetic Resonance Imaging
- DIAGNOSTIC_TEST MRI Ultrasound Fusion Guided Biopsy
Study Locations (4)
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
Maryland
- University of Maryland - Baltimore
Michigan
- Henry Ford Hospital Vattikuti Urology Institute - Detroit
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2028-05-23 |
| Phase | NA |
What the registry record for NCT03234556 still lists
NCT03234556 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 1,280-participant average among 6 other Health Status Unknown trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Health Status Unknown appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03234556 reports a single indexed study location in California, Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT03234556 about?
NCT03234556 is a clinical study titled "Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA". 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 i...
What is the current status of trial NCT03234556?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 288 participants. The study started on 2017-09-25. Estimated completion is 2028-05-23.
What conditions does trial NCT03234556 study?
This clinical trial studies the following conditions: Health Status Unknown, Elevated PSA.
What interventions are being tested in trial NCT03234556?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Biopsy of Prostate (PROCEDURE), Magnetic Resonance Imaging (DIAGNOSTIC_TEST), MRI Ultrasound Fusion Guided Biopsy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03234556?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03234556 being conducted?
This trial has 4 study locations across California, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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