Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Starting soon · Phase 3

Conditions studied: Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT06024772

Run by

Thomas Jefferson University

People needed

300

Starts

2026-07-01

Expected to finish

2027-02-01

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Amsterdam Medical Center — Amsterdam-Zuidoost, Netherlands

Full record on ClinicalTrials.gov

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