Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

NCT06024772 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: iRISID-2022-1191JT 20767
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy

  Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.

  Up to 2 years

Secondary Outcomes (2)

• PCa detection rate of 3D mp-US

  Up to 2 years

• Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI

  Up to 2 years

Study Arms (1)

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

EXPERIMENTAL

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

Procedure: ultiparametric Magnetic Resonance Imaging; Drug: Perflutren lipid microsphere; Procedure: Transrectal Ultrasound; Procedure: Biopsy of Prostate

Interventions

ultiparametric Magnetic Resonance Imaging PROCEDURE

Undergo mp-MRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

Perflutren lipid microsphere DRUG

Given IV

Also known as: Definity

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

Transrectal Ultrasound PROCEDURE

Undergo transrectal mp-US

Also known as: endorectal ultrasound, ERUS, TRUS

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

Biopsy of Prostate PROCEDURE

Undergo prostate biopsies

Also known as: Prostate Biopsy, Prostatic Biopsy

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Amsterdam UMC, location VUmc: collaborator
• Eindhoven University of Technology: collaborator
• Eigen: collaborator
• GE Healthcare: collaborator

Study Sites (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Amsterdam Medical Center

Amsterdam-Zuidoost, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

perflutren; Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Flemming Forsberg, PhD

CONTACT

215-955-4870; Flemming.Forsberg@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Radiology

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 6, 2023
• Study Start: March 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

NL (1); US (1)