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Multiparametric Ultrasound for Prostate Cancer Diagnosis

This study is comparing two imaging methods to diagnose prostate cancer: contrast-enhanced multiparametric ultrasound (mp-US) and multiparametric magnetic resonance imaging (mp-MRI). You would receive Perflutren lipid microsphere (Definity) intravenously (into a vein) to enhance the ultrasound images. Researchers want to see if mp-US, combined with a biopsy, is as good as mp-MRI at finding important prostate cancers. You might be able to join if you are a man, 18 years or older, and are scheduled for a prostate biopsy due to an elevated PSA (prostate-specific antigen) level, a fast-rising PSA, or an abnormal digital rectal exam. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 300 participants. It compares the detection rates of prostate cancer using two different imaging techniques.
What's involved
You would undergo an mp-MRI, receive Definity intravenously, and have a transrectal mp-US and prostate biopsies.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for prostate cancer detection is measured for up to 2 years.

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NCT06024772

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Not Yet Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Thomas Jefferson University
~300 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:ultiparametric Magnetic Resonance ImagingPerflutren lipid microsphereTransrectal UltrasoundBiopsy of Prostate

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy
Measured over Up to 2 years

Conditions

Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 2 states
Pennsylvania1
Netherlands1

Who to contact

Flemming Forsberg, PhD
[email protected]
215-955-4870
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject must be scheduled for a prostate biopsy, based on an elevated PSA (\> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (\> 0.75ng/ml/year), or abnormal digital rectal examination
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies
Subject must be a male at least 18 years of age when informed consent is obtained

Exclusion

Participant in a clinical trial involving an investigational drug within the past 30 days
Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity
Previous treatment for prostate cancer, including hormone therapy
Clinically unstable, severely ill, or moribund as per treating physician

What this trial measures

  • Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsyUp to 2 years

    Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.