Back to resultsARFI Imaging for Targeted Prostate Biopsy
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustic radiation force impulse (ARFI)
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Transrectal Ultrasound, Prostate biopsy
Eligibility Criteria
Inclusion Criteria:
- Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy;
- Men who are willing to participate in the study;
- Subjects must freely sign informed consent to enroll in the study;
- Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation.
- 18 years or older
Exclusion Criteria:
- Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy;
- Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc);
- standard pharmacological treatment of BPH is allowable
- Men who are mentally impaired and cannot give written consent;
- Men with anomalies of the rectum.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acoustic radiation force impulse (ARFI)
MR-ultrasound fusion
Arm Description
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Outcomes
Primary Outcome Measures
PCa detection rate
Length of cancerous tissue
Grade of cancerous tissue
Gleason score
A commonly used method to classify how cells appear in cancerous tissues; the less the cancerous cells look like normal cells, the more malignant the cancer; two numbers, each from 1 to 5, are assigned to the two most predominant types of cells present. These two numbers are added together to produce the Gleason score. Higher numbers indicate more aggressive cancers.
Gleason Grade Group
A newer technique to stratify prostate cancer risk, 5 categories.
Clinically significant disease (CSD) as measured by biopsy score.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04607135
Brief Title
ARFI Imaging for Targeted Prostate Biopsy
Official Title
Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Current sample size sufficiently powers the study to evaluate outcome measures
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Transrectal Ultrasound, Prostate biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acoustic radiation force impulse (ARFI)
Arm Type
Experimental
Arm Description
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Arm Title
MR-ultrasound fusion
Arm Type
Active Comparator
Arm Description
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Intervention Type
Device
Intervention Name(s)
Acoustic radiation force impulse (ARFI)
Intervention Description
Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen
Primary Outcome Measure Information:
Title
PCa detection rate
Time Frame
Up to 30 mins
Title
Length of cancerous tissue
Time Frame
Up to 30 mins
Title
Grade of cancerous tissue
Time Frame
Up to 30 mins
Title
Gleason score
Description
A commonly used method to classify how cells appear in cancerous tissues; the less the cancerous cells look like normal cells, the more malignant the cancer; two numbers, each from 1 to 5, are assigned to the two most predominant types of cells present. These two numbers are added together to produce the Gleason score. Higher numbers indicate more aggressive cancers.
Time Frame
Up to 30 mins
Title
Gleason Grade Group
Description
A newer technique to stratify prostate cancer risk, 5 categories.
Time Frame
Up to 30 mins
Title
Clinically significant disease (CSD) as measured by biopsy score.
Time Frame
Up to 30 mins
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy;
Men who are willing to participate in the study;
Subjects must freely sign informed consent to enroll in the study;
Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation.
18 years or older
Exclusion Criteria:
Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy;
Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc);
standard pharmacological treatment of BPH is allowable
Men who are mentally impaired and cannot give written consent;
Men with anomalies of the rectum.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Polascik, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn Nightingale, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ARFI Imaging for Targeted Prostate Biopsy
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