Micro-Ultrasound Imaging for Prostate Cancer

Overseen By Ned U Realiza

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Does not consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

95 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment ExactVu for prostate cancer?

The ExactVu micro-ultrasound system has been shown to provide a much clearer image of the prostate, with a 300% higher resolution than traditional methods, helping to detect significant prostate cancer more accurately. It has been used to identify suspicious areas in the prostate that led to further testing and diagnosis of cancer, demonstrating its effectiveness in early detection. ^{1 2 3 4 5}

Is micro-ultrasound imaging for prostate cancer safe for humans?

The ExactVu micro-ultrasound system is approved by the FDA, CE, and Health Canada for prostate visualization and biopsy, indicating it meets safety standards for these uses. ^{1 2 6 7 8}

How does micro-ultrasound imaging differ from other treatments for prostate cancer?

Micro-ultrasound imaging is a new technique that offers much higher resolution than traditional ultrasound, allowing for better detection and visualization of prostate cancer. It is a non-invasive, real-time imaging method that can be used for both diagnosis and guiding biopsies, potentially offering a more accessible and cost-effective alternative to MRI. ^{1 2 3 4 9}

Research Team

Geoffrey Sonn

Principal Investigator

Stanford Universiy

Eligibility Criteria

This trial is for men scheduled to undergo a prostate biopsy or removal due to cancer, who are willing to give their consent. It's not open to those who do not agree to participate.

Inclusion Criteria

Agree to consent to the study

I am scheduled for a prostate biopsy or complete prostate removal.

Exclusion Criteria

Does not agree to consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo micro-ultrasound imaging of the prostate before biopsy or surgery

1 week

1 visit (in-person)

Analysis

Analysis of micro-ultrasound images compared to other imaging modalities and pathology

7 days

Follow-up

Participants are monitored for safety and effectiveness after imaging and analysis

1 year and 10 months

Treatment Details

Interventions

• ExactVu

Trial Overview The study is testing the use of a high-resolution micro-ultrasound system called ExactVu. The aim is to capture detailed images of the prostate before biopsy or surgery and compare these with other imaging methods and actual tissue pathology.

Participant Groups

Group I: ExactVu Imaging Experimental Treatment 1 Intervention

EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: 1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

The ExactVu™ Micro-Ultrasound system is an FDA-approved imaging technology that allows for high-resolution visualization of the prostate, which can aid in the detection of prostate cancer.

In a case study involving a healthy 50-year-old man with no known risk factors, the use of the ExactVu system identified multiple lesions classified as PRI-MUS 3-5, leading to further testing and a diagnosis of significant prostate cancer, highlighting its efficacy in early cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspicious findings on micro-ultrasound imaging and early detection of prostate cancer. Ghai, S., Van der Kwast, T.[2020]

ExactVuTM, a high-resolution micro-ultrasound system, demonstrated a sensitivity of 74% and specificity of 75% for detecting clinically significant prostate cancer (CsPCa) in the peripheral zone, indicating its potential effectiveness in identifying this type of cancer.

The system showed a positive predictive value (PPV) of 94% for detecting CsPCa in the peripheral zone, suggesting that when ExactVuTM indicates a positive result, it is likely to be accurate, although further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of the Novel 29 MHz micro-ultrasound "ExactVuTM" for the detection of clinically significant prostate cancer: A prospective single institutional study. A step forward in the diagnosis of prostate cancer. Chessa, F., Schiavina, R., Ercolino, A., et al.[2021]

In a study involving 1676 men, high-frequency micro-ultrasound (micro-US) did not show a significant advantage over conventional ultrasound (conv-US) for detecting clinically significant prostate cancer (csPCa) during prostate biopsies, with detection rates of 34.6% for micro-US and 36.6% for conv-US.

However, after implementing a training protocol for interpreting micro-US images, sensitivity for detecting csPCa improved significantly from 24.6% to 60.8%, indicating that training can enhance the effectiveness of this imaging technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy. Pavlovich, CP., Hyndman, ME., Eure, G., et al.[2022]

In a first-in-human study involving 24 patients with prostate cancer, the ultrasound molecular contrast agent BR55 was found to be safe, with no serious adverse events reported during or after its administration.

BR55 successfully detected 50% of malignant lesions identified by histopathology, and with an improved imaging protocol, this detection rate increased to 68%, indicating its potential effectiveness for cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study. Smeenge, M., Tranquart, F., Mannaerts, CK., et al.[2022]

There is currently no robust data on the long-term effectiveness of high intensity focused ultrasound (HIFU) for treating localized prostate cancer in the United States, which poses challenges for clinical decision-making.

Patient preference data regarding the safety and effectiveness of HIFU treatment for prostate cancer is lacking, highlighting the need for future studies to better inform patients and regulators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Ablation Using High Intensity Focused Ultrasound: A Literature Review of the Potential Role for Patient Preference Information. Babalola, O., Lee, TJ., Viviano, CJ.[2019]

In a study of 100 patients with low-risk prostate cancer, micro-ultrasound (microUS) demonstrated high sensitivity (94.1%) for detecting clinically significant cancer (ISUP ≥ 2), making it a valuable tool for monitoring patients on active surveillance.

MicroUS can effectively identify suspicious lesions and may reduce the need for confirmatory biopsies, although it may miss some upgraded cases; it serves as a viable alternative to mpMRI in guiding targeted biopsies for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer. Maffei, D., Fasulo, V., Avolio, PP., et al.[2023]

High resolution micro-ultrasound (micro-u/s) offers a resolution of 70 μm, allowing for detailed visualization of prostate lesions and potentially superior sensitivity for detecting clinically significant prostate cancer compared to mpMRI.

Micro-u/s is a cost-effective and accessible alternative to mpMRI for prostate cancer imaging, with comparable specificity, making it a promising tool for diagnosis in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Laurence Klotz, CM.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Suspicious findings on micro-ultrasound imaging and early detection of prostate cancer. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of the Novel 29 MHz micro-ultrasound "ExactVuTM" for the detection of clinically significant prostate cancer: A prospective single institutional study. A step forward in the diagnosis of prostate cancer. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Use of high-resolution micro-ultrasound to predict extraprostatic extension of prostate cancer prior to surgery: a prospective single-institutional study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Detection of Clinically Significant Index Prostate Cancer Using Micro-ultrasound: Correlation With Radical Prostatectomy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prostate Ablation Using High Intensity Focused Ultrasound: A Literature Review of the Potential Role for Patient Preference Information. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? [2021]