Clinical trial NCT04607135: ARFI Imaging for Targeted Prostate Biopsy
Official title: Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Transrectal Ultrasound
Prostate biopsy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade
timeFrame: Up to 30 minutes
measure: Length of Cancerous Tissue
timeFrame: Up to 30 minutes
measure: Grade Group of Cancerous Tissue
timeFrame: Up to 30 minutes
measure: Gleason Score
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected
timeFrame: Up to 30 minutes
measure: Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5
timeFrame: Up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas Polascik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Kathryn Nightingale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan DY. A 3-D Multiparametric Ultrasound Elasticity Imaging System for Targeted Prostate Biopsy Guidance [dissertation]. Durham (NC): Duke University; 2023.
citation: 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.
citation: 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.