Multiparametric Ultrasound + MRI for Prostate Cancer

Recruiting at 1 trial location

Overseen By Flemming Forsberg, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adult men who need a prostate biopsy due to high PSA levels, increased PSA velocity, or abnormal rectal exams. They must be willing to consent to an ultrasound study with additional biopsies and have not had any treatments for prostate cancer including hormone therapy.

Inclusion Criteria

I am willing to sign consent for a special ultrasound and extra biopsies of my prostate.

I am a man aged 18 or older.

I am scheduled for a prostate biopsy due to high PSA or an abnormal exam.

Exclusion Criteria

I have received treatment for prostate cancer, including hormone therapy.

Clinically unstable, severely ill, or moribund as per treating physician

You have a known or suspected allergy to perflutren, polyethylene glycol (PEG), or any other ingredient in Definity.

Treatment Details

Interventions

• Biopsy of Prostate (Procedure)
• Multiparametric Magnetic Resonance Imaging (Procedure)
• Multiparametric Ultrasound (Procedure)
• Perflutren lipid microsphere (Drug)

Trial Overview The trial compares contrast-enhanced multiparametric ultrasound (mp-US) using Definity with standard multiparametric MRI (mp-MRI) in diagnosing significant prostate cancer. It aims to see if mp-US can more accurately guide targeted biopsies.

Participant Groups

Group I: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) Experimental Treatment 4 Interventions

Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Amsterdam UMC, location VUmc

Collaborator

Trials

421

Recruited

218,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Eindhoven University of Technology

Collaborator

Trials

25

Recruited

4,300+

Eigen

Collaborator

Trials

3

Recruited

560+