NCT03035487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 4, 2019

Completed
Last Updated

May 15, 2019

Status Verified

April 1, 2019

Enrollment Period

Same day

First QC Date

January 16, 2017

Results QC Date

November 5, 2018

Last Update Submit

April 30, 2019

Conditions

Prostate CancerCancer of the PROSTATEProstatic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Keyword Description of Each Biopsy Sample

    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.

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

Study Arms (1)

Micro-ultrasound

EXPERIMENTAL

Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities: * Low resolution transrectal ultrasound examination ("LR-TRUS") * Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol

Device: Ultrasound guided prostate exam using SOC ultrasound systemDevice: mpMRI guided prostate examination using PI-RADS v2Device: High-resolution micro-ultrasound guided prostate biopsy

Interventions

Ultrasound guided prostate exam using SOC ultrasound systemDEVICE
Micro-ultrasound
mpMRI guided prostate examination using PI-RADS v2DEVICE

mpMRI guided prostate examination using standard of care MRI system

Micro-ultrasound
High-resolution micro-ultrasound guided prostate biopsyDEVICE
Also known as: ExactVu micro-ultrasound imaging system
Micro-ultrasound

Eligibility Criteria

Age40 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PSA\<50
  • Clinical stage \< cT2c

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology of Virginia

Virginia Beach, Virginia, 23452, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Manager, Clinical Research
Organization
Exact Imaging
bwodlinger@exactimaging.com
905-415-0030

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 30, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2018

Last Updated

May 15, 2019

Results First Posted

March 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)