Status:
NOT_YET_RECRUITING
Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Eindhoven University of Technology
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 prostat...
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-MR...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06024772
Start Date
March 15 2026
End Date
February 1 2027
Last Update
December 22 2025
Active Locations (2)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
2
Amsterdam Medical Center
Amsterdam-Zuidoost, Netherlands