# Image guided targeted biopsy of clinically significant prostate cancer with acoustic radiation force

> **NIH NIH R01** · DUKE UNIVERSITY · 2021 · $474,245

## Abstract

Abstract: Over 1,000,000 biopsies are performed annually in the United States to diagnose prostate cancer
(PCa)[1]. Prostate biopsies are performed using transrectal ultrasound (TRUS) guidance to diagnose PCa when
suspicion is raised through screening mechanisms. However, ultrasonic prostate imaging does not facilitate targeting biopsies to suspicious regions because PCa does not have unique B-mode image characteristics that can
delineate diseased tissues from normal structures and benign pathologies. Therefore, the current standard of
care has poor sensitivity mainly because the sampling grid, which samples <5% of the prostate, only randomly
intersects pathologic tissues. As a result, PCa detection rates are only 18-36% for both ﬁrst and second-time
repeat biopsies[1–5]. In addition, many of the cancers that are detected with the systematic sampling approach
are clinically insigniﬁcant [2, 6], leading to overly aggressive treatment that adversely affects patients and places
an unnecessary burden on our healthcare system. During the previous funding cycle we developed a novel 3D
Acoustic Radiation Force Impulse (ARFI) prostate ultrasound elasticity imaging system. Our experience with
3D ARFI prostate imaging in over 100 patients demonstrated the exciting result that 3D ARFI imaging
is speciﬁc for clinically signiﬁcant disease (CSD)[7], which means it can be used to screen the entire
prostate gland and target biopsies toward regions suspicious for CSD. We have identiﬁed the key technical challenges that must be addressed to bring a low-cost, 3D-ARFI prostate cancer screening and targeted
biopsy guidance system into the current clinical work-ﬂow. In this competing renewal, submitted under PAR-
15-075 for academic-industrial collaborations, we propose to partner with Siemens ultrasound to resolve these
challenges and build a clinic-ready system and assess its performance in the clinic as compared to systematic
TRUS biopsy. The proposed system will remove the random nature of systematic sampling, facilitating initial diagnosis based upon the most aggressive disease present in the gland. We hypothesize that
this system will reduce the required number of biopsy cores, the number of repeat biopsy procedures, and the
number of unnecessary radical prostatectomies associated with PCa. There are 3 speciﬁc aims: 1) To translate
our prototype system into a clinic-ready system through: development and integration of a custom designed,
side-ﬁre transrectal transducer and biopsy needle guides, implementation of our data processing and 3D data
visualization tools on-board a state-of-the-art prototype ultrasound scanner, and integration of positioning feedback in the motorized rotation system. 2) To assess the performance of the 3D TRUS ARFI targeted biopsy
guidance system in tissue mimicking phantoms. 3) To assess the performance of 3D ARFI in vivo in humans
in targeting clinically signiﬁcant prostate disease.

## Key facts

- **NIH application ID:** 10208767
- **Project number:** 5R01CA142824-10
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Kathryn Radabaugh Nightingale
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $474,245
- **Award type:** 5
- **Project period:** 2010-01-18 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10208767

## Citation

> US National Institutes of Health, RePORTER application 10208767, Image guided targeted biopsy of clinically significant prostate cancer with acoustic radiation force (5R01CA142824-10). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10208767. Licensed CC0.

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