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Completed

NCT Number: NCT03035487

Urology of Virginia Case Series

The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.

The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).

These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.

In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.

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Key information

Conditions

Prostate Cancer Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasm Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology of Virginia

Virginia Beach, Virginia, 23452, United States

About this study

This trial will enroll nine men with an indication for a prostate biopsy.

The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.

The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.

Procedures in the study are:

  • obtain informed consent for the subject
  • image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report
  • perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit)
  • prepare biopsy specimens for pathology
  • record all procedure details in a case report form, including pathology and mpMRI reports

The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities.

Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
  • PSA<50
  • Clinical stage < cT2c

Exclusion criteria

Patients will be excluded from being included in the investigation if any of the following is true:

  • Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
  • Men with known prostate volume (from prior imaging) of > 60cc
  • Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
  • Men who are unable to provide their own informed consent
  • Men who have contraindications to MRI or gadolinium chelate contrast

Treatment and study plan

Ultrasound guided prostate exam using SOC ultrasound system

Device

mpMRI guided prostate examination using PI-RADS v2

Device

mpMRI guided prostate examination using standard of care MRI system

High-resolution micro-ultrasound guided prostate biopsy

Device

Other names: ExactVu micro-ultrasound imaging system

Primary outcomes

  1. Keyword Description of Each Biopsy Sample

    Time frame: For each patient, keywords will be assigned within one week following the patient's procedure.

    The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.

Sponsors and collaborators

Lead sponsor

Exact Imaging

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Jan 30, 2017
Registry last updated
May 15, 2019

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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