Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

NCT05336786 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 21G.1212R01CA252311JT 18100
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief Summary

This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate

  Up to 12 months

Study Arms (1)

Diagnostic (perflutren lipid microspheres, ultrasound)

EXPERIMENTAL

Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres

Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound

Interventions

Perflutren Lipid Microspheres DRUG

Given IV

Also known as: Definity

Diagnostic (perflutren lipid microspheres, ultrasound)

Ultrasound PROCEDURE

Undergo ultrasound

Diagnostic (perflutren lipid microspheres, ultrasound)

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 radical prostatectomy for treatment of prostate cancer
• Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
• 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, 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
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Amsterdam University Medical Centers

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

perflutren; High-Energy Shock Waves

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)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

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: April 7, 2022
• First Posted: April 20, 2022
• Study Start: June 15, 2022
• Primary Completion: May 26, 2025
• Study Completion (Estimated): May 26, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NL (1)