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Procedure

Multiparametric Ultrasound + MRI for Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be a male at least 18 years of age when informed consent is obtained
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
Must not have
Previous treatment for prostate cancer, including hormone therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial compares ultrasound (with bubbles) and MRI to diagnose prostate cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions to the contrast agent Definity such as hypersensitivity or allergy symptoms. The procedure itself might cause discomfort similar to that of regular transrectal ultrasounds and biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
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I am scheduled for a prostate biopsy due to high PSA or an abnormal exam.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received treatment for prostate cancer, including hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy
Secondary study objectives
Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI
PCa detection rate of 3D mp-US

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)Experimental Treatment4 Interventions
Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflutren lipid microsphere
2016
Completed Phase 2
~110
Transrectal Ultrasound
2012
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
456 Previous Clinical Trials
149,096 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,226 Patients Enrolled for Prostate Cancer
Amsterdam UMC, location VUmcOTHER
403 Previous Clinical Trials
212,902 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,360 Patients Enrolled for Prostate Cancer
GE HealthcareIndustry Sponsor
295 Previous Clinical Trials
633,266 Total Patients Enrolled
5 Trials studying Prostate Cancer
672 Patients Enrolled for Prostate Cancer
~200 spots leftby Aug 2026
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