Multiparametric Ultrasound + MRI for Prostate Cancer

Palo Alto (17 mi)

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 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.

Treatment Details

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.

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.