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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• Men only
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: A Prospective Cohort Study Comparing Multi-parametric Ultrasound Versus Multi-parametric MRI for Clinically Significant Prostate Cancer Detection

Conditions

PROSTATE CANCER, Prostate Biopsy

Being tested

Prostate imaging, Prostate biopsy

Keywords

prostate cancer, multiparametric ultrasound, multiparametric MRI

Medical subject headings

Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Prostate imagingDiagnostic 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.

• Prostate biopsyProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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 will be based on the final prostate biopsy histopathology report.

   Measured: Up to 12 weeks following imaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Dec 2023
2. Study start29 Dec 2023
3. Primary completion30 Jun 2025
4. Study completion31 Dec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for PROSTATE CANCERStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.