Urology San Antonio MRI/MicroUS Comparison

• Sponsor: Exact Imaging (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03762616
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.2
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: Micro-ultrasound targeted biopsy; Diagnostic Test: mpMRI targeted biopsy	N/A

Detailed Description

The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Masking Description: Investigator performing the micro-ultrasound biopsy will be blinded to the MRI report, and the investigator performing the MRI targeted biopsy will be blinded to the micro-ultrasound images and targets.
• Primary Purpose: Diagnostic
• Official Title: Urology San Antonio MRI/MicroUS Comparison
• Actual Study Start Date: Nov 28, 2018
• Actual Primary Completion Date: Nov 4, 2019
• Actual Study Completion Date: Nov 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Micro-Ultrasound Biopsy	Diagnostic Test: Micro-ultrasound targeted biopsy; Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
Experimental: MRI Targeted Biopsy	Diagnostic Test: mpMRI targeted biopsy; Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Clinically Significant Cancer [At time of biopsy]

   Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer

2. 40-75 years old

3. Available mpMRI images and report, performed according to the PI-RADS v2 standard

Exclusion Criteria:

1. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy

2. Men who are unable to provide their own informed consent

3. Prostate volume on MRI > 100cc

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology San Antonio - Pasteur Plaza Surgery Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Exact Imaging

Investigators

• Principal Investigator: David R Talley, MD, Urology San Antonio

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 19, 2018

More Information

Publications

None provided.

• Responsible Party: Exact Imaging
• ClinicalTrials.gov Identifier: NCT03762616
• Other Study ID Numbers: EVU-2018-001
• First Posted: Dec 4, 2018
• Last Update Posted: Apr 21, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Exact Imaging: multiparametric MRI; micro-ultrasound; prostate biopsy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Micro-ultrasound Biopsy Then MRI Biopsy
Arm/Group Description	Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by MRI biopsy by a second blinded operator
Period Title: Overall Study
STARTED	120
COMPLETED	118
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Micro-ultrasound Biopsy Then MRI Biopsy
Arm/Group Description	Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by... mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
Overall Participants	118
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	67
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	118 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	118 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinically Significant Cancer
Description	Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
Time Frame	At time of biopsy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Micro-ultrasound Biopsy	MRI Targeted Biopsy
Arm/Group Description	Micro-ultrasound biopsy: Micro-ultrasound biopsy using the ExactVu micro-ultrasound system	mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
Measure Participants	118	118
Count of Participants [Participants]	38 32.2%	31 NaN

Adverse Events

Time Frame	During biopsy procedure
Arm/Group Title	Micro-ultrasound Targeted Biopsy		MRI Targeted Biopsy
Arm/Group Description	Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system		mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
All Cause Mortality
	Micro-ultrasound Targeted Biopsy		MRI Targeted Biopsy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/118 (0%)
Serious Adverse Events
	Micro-ultrasound Targeted Biopsy		MRI Targeted Biopsy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/118 (0%)
Other (Not Including Serious) Adverse Events
	Micro-ultrasound Targeted Biopsy		MRI Targeted Biopsy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/118 (0%)

Limitations/Caveats

Due to issues with marking of targeted samples the primary endpoint was modified to distinguish between the two devices used in the arms rather than biopsy annotations.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.