ARFI Imaging for Targeted Prostate Biopsy

April 29, 2025 updated by: Duke University

Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acoustic radiation force impulse (ARFI)
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Device: Acoustic radiation force impulse (ARFI)
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
Active Comparator: MR-ultrasound fusion
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Device: Ultrasound
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade
Time Frame: Up to 30 minutes
Up to 30 minutes
Length of Cancerous Tissue
Time Frame: Up to 30 minutes
Length of carcinoma per cancer-positive biopsy specimen as reported by the pathology findings, computed from all cancer-positive biopsy specimens from a given biopsy approach for each participant in whom cancer of any grade was detected by any biopsy approach.
Up to 30 minutes
Grade Group of Cancerous Tissue
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk. For each subject, the highest grade group detected by a given biopsy approach is assigned to that subject for that biopsy approach.
Up to 30 minutes
Gleason Score
Time Frame: Up to 30 minutes
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 with a total range of 2 to 10. Higher numbers indicate more aggressive cancers. For each subject, the highest Gleason score detected by a given biopsy approach is assigned to that subject for that biopsy approach.
Up to 30 minutes
Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes
Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5
Time Frame: Up to 30 minutes
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Polascik, MD, Duke University
  • Principal Investigator: Kathryn Nightingale, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00106093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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