Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05336786

Enrollment

Registered

2022-04-20

Start date

2022-06-15

Completion date

2026-05-26

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

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.

Interventions

DRUGPerflutren Lipid Microspheres

Given IV

PROCEDUREUltrasound

Undergo ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026