A Cognitive Fusion-guided Prostate Biopsy Using Multiparametric Magnetic Resonance Imaging and Transrectal Ultrasound

Summary

Prostate biopsy is the gold standard diagnostic method for prostate cancer. Cognitive fusion-guided prostate biopsy, which combines transrectal ultrasound with pre-measured MRI parameters, improves biopsy accuracy and enhances the detection rate of clinically significant prostate cancer.

Abstract

Traditional transrectal ultrasound (TRUS)-guided prostate biopsy has limited sensitivity and specificity, particularly for detecting early-stage prostate cancer, due to a lack of precise lesion targeting. An improved cognitive fusion-guided prostate biopsy method has been developed to enhance lesion targeting by integrating three parameters of prostate multiparametric MR (mpMRI) images into TRUS images. Prostate mpMRI measurement is initially performed to obtain three key parameters: the rotation angle (α), the distance from the rectal wall (X), and the distance from the prostate apex (Y). These parameters are then cognitively applied in real-time, TRUS-guided prostate needle biopsy to detect target lesions. This improved transperineal cognitive fusion biopsy method enhances diagnostic accuracy, improves reproducibility, and reduces reliance on operator experience. Clinical application in 423 patients demonstrated a prostate cancer detection rate of 73.5%, with 62.9% classified as clinically significant cancers. Compared with equipment-intensive methods such as MRI-ultrasound fusion biopsy, this approach is cost-effective, practical, and well-suited for broader clinical adoption. Additionally, the method's flexibility supports integration with other imaging techniques, such as ⁶⁸Ga-PSMA PET/CT, further improving detection rates for patients with high-risk prostate cancer.

Introduction

Prostate cancer is a major global health concern, with an estimated 1,466,680 new cases and 396,792 deaths reported worldwide in 2022. Prostate cancer is the second most common cancer and the fifth leading cause of cancer death among men¹. By 2040, the number of new prostate cancer cases is projected to rise to 2.9 million, with deaths expected to reach 700,000². Early diagnosis and standardized treatment are crucial for improving survival rates in patients with prostate cancer, and prostate biopsy remains the gold standard for early diagnosis.

Since 1968, transrectal ultrasound (TRUS) has bee....

Protocol

This study involving human participants was conducted in accordance with the principles outlined in the Declaration of Helsinki. Written informed consent was obtained from all participants prior to their inclusion in the study. The inclusion and exclusion criteria were carefully defined to ensure participant safety and the suitability of the procedure.

1. Patient selection

1. Set the following inclusion criteria for patient selection: prostate-specific antigen (PSA) > 10 ng/mL; presence of a suspicious prostate nodule detected by digital rectal examination (DRE), irrespective of PSA level; suspicious lesions id....

Results

In this case, the cognitive fusion-guided prostate biopsy accurately identified a clinically significant prostate cancer lesion. This lesion was indicated by MRI in the left apex of the prostate with a maximum diameter of approximately 6 mm and a PI-RADS score of 4, suggesting a high likelihood of clinically significant prostate cancer.

The pathologic diagnosis of this biopsy lesion was prostatic acinar adenocarcinoma with the following details (Figure 5):

Discussion

MRI-guided biopsy (MRI-GB) is a cornerstone of targeted prostate biopsy and includes MRI-targeted biopsy (MRI-TB), MRI-transrectal ultrasound fusion biopsy (FUS-TB), and cognitive fusion biopsy (COG-TB). MRI-TB achieves high diagnostic accuracy through real-time MR imaging, with an overall cancer detection rate of 80% and a clinically significant cancer detection rate of 55%⁹. However, its high cost and operational complexity limit its widespread use. FUS-TB combines MRI precision with real-time u.......

Materials

Name	Company	Catalog Number	Comments
5% Povidone-Iodine Solution	Chengdu Yong'an Pharmaceutical Co., Ltd.	H51022885	For disinfection of the surgical area
10% Neutral Buffered Formalin Fixative	Guangzhou Vigrass Biotechnology Co., Ltd.	24010506	For fixing biopsy tissue
AccuCARE Transperineal Solutions	CIVCO Medical Instruments Co., Inc	620-119	For supporting the probe
Injection syringe (20 mL)	Shandong weigao group medical polymer Co., LTD	20211001	For local anesthesia
Lidocaine	Hubei Tiansheng Pharmaceutical Co., Ltd.	H42021839	Diluted with saline to 1% for local anesthesia
MRI 3.0T	Philips	Ingenia	For prostate examination
RadiAnt DICOM Viewer	Medixant	V2024.1	For reading prostate MRI, outlining lesions, measuring distances, and angles
Single-use Biopsy Needle MC1820	Bard Peripheral Vascular, Inc.	REHU3231	For needle biopsy sampling
Single-use Sterile Needle 0.7 x 80 TWLB	Zhejiang Kangdeli Medical Devices Co., Ltd.	C20230923	For local anesthesia
Sodium chloride injection	Southwest pharmaceutical Co., LTD	H50021610	For diluting lidocaine
Ultrasound	BK Medical	bk3000-01	For guiding prostate biopsy