Micro-Ultrasound Imaging for Prostate Cancer

(MUSIC-AS Trial)

Overseen By Adam Kinnaird, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Cannot undergo MRI, biopsy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment High-resolution micro-ultrasound for prostate cancer?

Research shows that high-resolution micro-ultrasound, like the ExactVu system, provides much clearer images of the prostate compared to traditional methods, helping doctors find significant prostate cancer more accurately. It has been found to be as good as or better than MRI in detecting important prostate cancer, making it a useful tool for diagnosis. ^{1 2 3 4 5}

Is micro-ultrasound imaging 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. ^{3 5 6 7 8}

How is the micro-ultrasound treatment for prostate cancer different from other treatments?

The micro-ultrasound treatment for prostate cancer is unique because it offers a much higher resolution imaging compared to traditional ultrasound, allowing for better visualization of prostate cancer lesions. This high-resolution imaging can detect significant prostate cancer that might be missed by MRI, making it a more accessible and convenient alternative for diagnosing prostate cancer. ^{2 3 4 5 9}

Eligibility Criteria

This trial is for adult men with low-grade prostate cancer (Gleason Grade Group 1) who are being monitored closely rather than receiving immediate treatment and need a confirmatory biopsy. Participants must be able to undergo both a prostate biopsy and an MRI.

Inclusion Criteria

I am a man with low-risk prostate cancer under active surveillance needing a confirmatory biopsy.

Exclusion Criteria

I cannot have a prostate biopsy.

I am unable to have a prostate MRI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy Session

Participants undergo a combined MRI and micro-ultrasound guided prostate biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy

4 weeks

Treatment Details

Interventions

• High-resolution micro-ultrasound

Trial Overview The study is testing if high-resolution micro-ultrasound imaging is as good as MRI in detecting significant changes in prostate cancer during active surveillance. It involves taking targeted samples using micro-ultrasound, then MRI, followed by systematic biopsies.

Participant Groups

Group I: Combined MRI and micro-ultrasound guided prostate biopsy. Experimental Treatment 1 Intervention

In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.

High-resolution micro-ultrasound is already approved in United States, Canada, European Union for the following indications:

Approved in United States as ExactVu micro-ultrasound for:

• Prostate cancer diagnosis and monitoring

Approved in Canada as ExactVu micro-ultrasound for:

• Prostate cancer diagnosis and monitoring

Approved in European Union as ExactVu micro-ultrasound for:

• Prostate cancer diagnosis and monitoring

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

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 study of 75 biopsy-naive men, high-resolution micro-ultrasound (microUS) combined with MRI significantly improved the detection of clinically significant prostate cancer (csPCa), identifying csPCa in 52% of cases during biopsies.

The Prostate Risk Identification using MicroUS (PRI-MUS) score was effective in stratifying cancer risk, with cores scoring PRI-MUS ≥3 showing a 3.5-fold higher likelihood of detecting csPCa compared to those scoring PRI-MUS ≤2, highlighting the potential of microUS as a valuable tool in prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of clinically significant prostate cancer by micro-ultrasound-informed systematic biopsy during MRI/micro-ultrasound fusion biopsy. Wang, B., Broomfield, S., Martín, AM., et al.[2023]

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]

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]

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]

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]

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]

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]

Micro-ultrasound (Micro-US) demonstrated a sensitivity of 76.5% and specificity of 76.6% in detecting prostate cancer index lesions, showing good reliability in diagnosis.

When compared to multiparametric MRI (mpMRI), Micro-US performed similarly, with mpMRI showing a sensitivity of 65.1% and higher specificity of 93.4%, indicating that Micro-US can be a viable alternative for prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Micro-Ultrasound and Multiparametric MRI Regarding the Correct Identification of Prostate Cancer Lesions. Lorusso, V., Kabre, B., Pignot, G., et al.[2022]

References

1. 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]

2. Canada pubmed.ncbi.nlm.nih.gov

Detection of clinically significant prostate cancer by micro-ultrasound-informed systematic biopsy during MRI/micro-ultrasound fusion biopsy. [2023]

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

8. 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]

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

Comparison Between Micro-Ultrasound and Multiparametric MRI Regarding the Correct Identification of Prostate Cancer Lesions. [2022]