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

NCT06183905 | Unknown DMC

• 2 other identifiers: XH-23-01221y11911000
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cohort study is to investigate multiparametric ultrasound versus multiparametric MRI for clinically significant prostate cancer detection in patients scheduled for initial biopsy. The main questions it aims to answer are:

• whether the clinically significant prostate cancer detection rate of multiparametric ultrasound is comparable to multiparametric MRI
• the any cancer detection of multiparametric ultrasound versus multiparametric MRI Participants will undergo multiparametric ultrasound and multiparametric MRI before prostate biopsy. In case of suspicious findings on ultrasound or MRI, they will undergo combined systematic biopsy and targeted biopsy. In case of nonsuspicious imaging finding, they will undergo systematic biopsy alone.

Conditions

PROSTATE CANCER; Prostate Biopsy

Keywords

prostate cancer; multiparametric ultrasound; multiparametric MRI

Outcome Measures

Primary Outcomes (1)

• clinically significant prostate cancer detection

  The primary definition was Grade Group(GG) ≥ 2. The secondary definition included PROMIS definition 1 (GG ≥ 3 and/or maximal cancer core length ≥ 6 mm) and PROMIS definition 2 (GG ≥ 2 and/or maximal cancer core length ≥ 4 mm). The measurement that will be based on biopsy histopathology.

  Up to 12 weeks following imaging

Secondary Outcomes (2)

• Any cancer detection

  Up to 12 weeks following imaging

• Clinically insignificant prostate cancer detection

  Up to 12 weeks following imaging

Study Arms (1)

Imaging (multiparametric ultrasound and multiparametric MRI)

EXPERIMENTAL

All patients will undergo multiparametric ultrasound and multiparametric MRI. In case of suspicious multiparametric ultrasound and/or multiparametric MRI,they will undergo combined targeted biopsy and systematic biopsy. In case of nonsuspicious imaging findings, only systematic biopsy will be performed.

Diagnostic Test: Prostate imaging; Procedure: Prostate biopsy

Interventions

Prostate imaging DIAGNOSTIC_TEST

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.

Imaging (multiparametric ultrasound and multiparametric MRI)

Prostate biopsy PROCEDURE

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.

Imaging (multiparametric ultrasound and multiparametric MRI)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for prostate biopsy;
• Signed the informed consent.

You may not qualify if:

• Contraindications to MRI, such as metal implants, claustrophobia, etc;
• Contraindications to ultrasound, such as acute myocardial infarction, acute cerebral infarction and rectal tumor after Miles operation;
• Contraindications of prostate biopsy, such as abnormal routine urine test, coagulation function and electrocardiogram
• Any medical condition or other event that may significantly reduce the chances of obtaining reliable data, achieving the purpose of the study or completing the study and follow-up;
• The study doctor thinks it is not suitable to participate in this study.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yunkai Zhu

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunkai Zhu

CONTACT

+86-13818674709; zhuyunkai@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 28, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)