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Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer

NCT02079025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1676

Last updated 2019-02-26

Study results available
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Summary

This trial uses a ultra high-resolution ultrasound system and specialized transducer, intended for use in prostate imaging. The system's image resolution is significantly better than the standard of care, due to its higher frequency. This allows the system to visualize suspicious areas and structures, and for greater accuracy for guided biopsy.

The primary objective of this study is to demonstrate that ultra high-resolution transrectal ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer and with an indication for prostate biopsy.

The secondary objective of this study is to compare the difference in the rate of detection of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator training to after investigator training.

The tertiary objective for the investigation is to compare the combined sensitivity and specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs. LR-TRUS.

Conditions

Interventions

DEVICE

High-resolution ultrasound guided prostate biopsy

Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system

DEVICE

Standard ultrasound guided prostate biopsy

Ultrasound guided prostate biopsy using standard of care ultrasound system

Sponsors & Collaborators

  • Exact Imaging

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31
Completion
2018-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02079025 on ClinicalTrials.gov