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Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
Sponsor: Thomas Jefferson University
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.
Official title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-03-15
Completion Date
2027-02
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
ultiparametric Magnetic Resonance Imaging
Undergo mp-MRI
Perflutren lipid microsphere
Given IV
Transrectal Ultrasound
Undergo transrectal mp-US
Biopsy of Prostate
Undergo prostate biopsies
Locations (2)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Amsterdam Medical Center
Amsterdam-Zuidoost, Netherlands