ARFI Imaging for Targeted Prostate Biopsy

NCT04607135 | Terminated Results FDA Device

• 1 other identifier: Pro00106093
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Transrectal Ultrasound; Prostate biopsy

Outcome Measures

Primary Outcomes (13)

• Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade

  Up to 30 minutes

• Length of Cancerous Tissue

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Acoustic radiation force impulse (ARFI)

EXPERIMENTAL

Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.

Device: Acoustic radiation force impulse (ARFI)

MR-ultrasound fusion

ACTIVE COMPARATOR

Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.

Device: Ultrasound

Interventions

Acoustic radiation force impulse (ARFI) DEVICE

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

Acoustic radiation force impulse (ARFI)

Ultrasound DEVICE

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

MR-ultrasound fusion

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (3)

• Chan DY. A 3-D Multiparametric Ultrasound Elasticity Imaging System for Targeted Prostate Biopsy Guidance [dissertation]. Durham (NC): Duke University; 2023.

  RESULT

• Chan DY, Moavenzadeh SR, Wightman WE, Palmeri ML, Polascik TJ, Nightingale KR. Clinical Feasibility of 3-D Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy Guidance. Ultrason Imaging. 2025 Mar;47(2):79-92. doi: 10.1177/01617346241311901. Epub 2025 Jan 6.

  PMID: 39760302 RESULT

• Moavenzadeh SR, Chan DY, Adams ES, Deivasigamani S, Kotamarti S, Palmeri ML, Polascik TJ, Nightingale KR. Evaluation of 3D ARFI imaging of prostate cancer: diagnostic reliability and concordance with MpMRI. Cancer Imaging. 2025 Apr 23;25(1):55. doi: 10.1186/s40644-025-00874-0.

  PMID: 40270056 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Elasticity Imaging Techniques; Ultrasonography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Kathy Nightingale, Ph.D.
• Organization: Duke University

kathy.nightingale@duke.edu

919-660-5175

Study Officials

• Thomas Polascik, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Kathryn Nightingale, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: October 22, 2021
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: May 6, 2025
• Results First Posted: January 5, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)