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NOT YET RECRUITING
NCT06024772
PHASE3

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

Summary

This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US) to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically significant prostate cancer when compared to standard of care mp-MRI.

Official title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03-15

Completion Date

2027-02

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

PROCEDURE

ultiparametric Magnetic Resonance Imaging

Undergo mp-MRI

DRUG

Perflutren lipid microsphere

Given IV

PROCEDURE

Transrectal Ultrasound

Undergo transrectal mp-US

PROCEDURE

Biopsy of Prostate

Undergo prostate biopsies

Locations (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Amsterdam Medical Center

Amsterdam-Zuidoost, Netherlands