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Completed

NCT Number: NCT04981223

Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging

The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 95304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
  • Agree to consent to the study

Exclusion criteria

  • Does not agree to consent.

Treatment and study plan

ExactVu

Device

clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging

Primary outcomes

  1. Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology

    Time frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)

    Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)

Secondary outcomes

  1. Prostate Cancer Border Identification Post-Prostatectomy

    Time frame: 3 years

    Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy.

  2. Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)

    Time frame: 1 year and 10 months

    Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)

  3. Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison

    Time frame: 1 year and 10 months

    Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).

  4. Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation

    Time frame: 3 years

    Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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