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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am a man aged 18 or older.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,414 Total Patients Enrolled

6 Trials studying Prostate Cancer

1,226 Patients Enrolled for Prostate Cancer

Amsterdam UMC, location VUmcOTHER

388 Previous Clinical Trials

196,051 Total Patients Enrolled

7 Trials studying Prostate Cancer

1,360 Patients Enrolled for Prostate Cancer

GE HealthcareIndustry Sponsor

289 Previous Clinical Trials

630,756 Total Patients Enrolled

4 Trials studying Prostate Cancer

172 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment of participants still underway for this trial?

"It appears that this medical study is no longer enrolling patients, as indicated by the data on clinicaltrials.gov. The trial was initiated on December 1st 2023 and its most recent update occurred August 29th 2023. While there currently aren't any available spots in this specific experiment, 1354 other trials are actively recruiting participants at present."

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