MedTrace Logo

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

NCT06024772 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Prostate Carcinoma

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

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Eindhoven University of Technology

    collaborator OTHER

  • Eigen

    collaborator OTHER

  • GE Healthcare

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-08-01
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024772 on ClinicalTrials.gov