Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Phase 3

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound

• Registration Number: NCT05336786
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.

II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.

OUTLINE:

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

After completion of study, patients are followed up for 30 days.

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Study Start: 2022-06-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-05-26
• Study Completion: 2026-05-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (perflutren lipid microspheres, ultrasound)	Ultrasound	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
Diagnostic (perflutren lipid microspheres, ultrasound)	Perflutren Lipid Microspheres	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

Primary Outcome Measures

Name	Time	Method
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate	Up to 12 months

Trial Locations

Locations (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Amsterdam University Medical Centers; 🇳🇱 Amsterdam, Netherlands