Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
NCT ID: NCT06024772
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2026-03-15
2027-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.
ultiparametric Magnetic Resonance Imaging
Undergo mp-MRI
Perflutren lipid microsphere
Given IV
Transrectal Ultrasound
Undergo transrectal mp-US
Biopsy of Prostate
Undergo prostate biopsies
Interventions
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ultiparametric Magnetic Resonance Imaging
Undergo mp-MRI
Perflutren lipid microsphere
Given IV
Transrectal Ultrasound
Undergo transrectal mp-US
Biopsy of Prostate
Undergo prostate biopsies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Eindhoven University of Technology
OTHER
Eigen
OTHER
GE Healthcare
INDUSTRY
Thomas Jefferson University
OTHER
Responsible Party
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Flemming Forsberg
Professor - Radiology
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Amsterdam Medical Center
Amsterdam-Zuidoost, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Flemming Forsberg, PhD
Role: primary
Harrie Beerlage, MD
Role: primary
Other Identifiers
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JT 20767
Identifier Type: OTHER
Identifier Source: secondary_id
iRISID-2022-1191
Identifier Type: -
Identifier Source: org_study_id