Multi-parametric Ultrasound Versus Multi-parametric MRI for Prostate Cancer Detection

NANot yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 31, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
PROSTATE CANCERProstate Biopsy
Interventions
DIAGNOSTIC_TEST

Prostate imaging

"Multiparametric ultrasound (mpUS) The mpUS examinations are performed in the order of greyscale imaging, elastography and contrast-enhanced ultrasound (CEUS), with the patients in the left lateral decubitus position.Greyscale imaging and elastography are evaluated by one radiologist. After standard step-sectional greyscale imaging, transverse elastic images are obtained from the base to the apex by manual compression. The amplitude and frequency of compression are adjusted according to the visual compression indicator on the screen to minimize interoperator variability. CEUS is performed using a bolus of 2.4 mL contrast agents (SonoVue, Bracco) using Contrast mode.~Multiparametric MRI (mpMRI) Prostate mpMRI images were acquired using a 3-T scanner with an external phased-array coil."

PROCEDURE

Prostate biopsy

All patients will undergo standard 12-core systematic biopsy (SB) within 1 week following the imaging protocol in conjunction with targeted biopsy (TB) for suspicious lesions on mpUS and/or mpMRI. First, 12-core SB is performed, followed by cognitive mpUS-TB with 2-3 cores for each suspicious lesion. The suspicious lesions on mpUS include hypoechoic lesion(s) on greyscale imaging, reproducible stiff lesion(s) on elastography, and hypoperfused area(s) with ill-defined boundaries or increased focal/asymmetric contrast enhancement on CEUS. Thereafter, MRI/US fusion TB is performed sampling 2-3 cores for each lesion with a Prostate Imaging Reporting and Data System (PI-RADS) version 2 score of 3 or above.Each biopsy sample is placed in the micro-cassette and labelled to identify the biopsy technique and location.

Trial Locations (1)

200092

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

All Listed Sponsors
lead

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

NCT06183905 - Multi-parametric Ultrasound Versus Multi-parametric MRI for Prostate Cancer Detection | Biotech Hunter | Biotech Hunter