NCT06024772

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. II. To compare the positive yield of targeted biopsy cores based on mp-US + systematic biopsy with targeted biopsy based on mp-MRI + systematic biopsy, for detection of clinically significant PCa. 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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	ultiparametric Magnetic Resonance Imaging	Undergo mp-MRI
DRUG	Perflutren lipid microsphere	Given IV
PROCEDURE	Transrectal Ultrasound	Undergo transrectal mp-US
PROCEDURE	Biopsy of Prostate	Undergo prostate biopsies

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2023-09-06
• Last updated: 2025-12-22

Locations

2 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study