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Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA

NCT03234556 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-12-22

No results posted yet for this 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.

Conditions

  • Health Status Unknown
  • Elevated PSA

Interventions

PROCEDURE

Biopsy of Prostate

Undergo SR-Bx

OTHER

Laboratory Biomarker Analysis

Correlative studies

DIAGNOSTIC_TEST

Magnetic Resonance Imaging

Undergo MRI

DIAGNOSTIC_TEST

MRI Ultrasound Fusion Guided Biopsy

Undergo MRUS-Bx

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Inderbir Gill · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2026-06-30
Completion
2028-05-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234556 on ClinicalTrials.gov