Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To demonstrate non-inferiority between the detection rate of clinically significant PCa with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI + systematic biopsy.

SECONDARY OBJECTIVES:

I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically significant PCa.

II. To construct an optimal logistic regression model to predict the presence of clinically significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA), PSA velocity and any other biological variables (e.g., age).

OUTLINE:

Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US and prostate biopsies on study. ;

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

• NCT number: NCT06024772
• Study type: Interventional
• Source: Thomas Jefferson University
• Contact: Flemming Forsberg, PhD
• Phone: 215-955-4870
• Email: Flemming.Forsberg@jefferson.edu
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Completion date: February 2027