Micro-Ultrasound Imaging for Prostate Cancer

(MUSIC-AS Trial)

Recruiting at 4 trial locations

Overseen By Stacey Broomfield, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of two imaging techniques, MRI and high-resolution micro-ultrasound, in monitoring prostate cancer under active surveillance. It aims to determine if micro-ultrasound matches MRI in detecting prostate cancer that may require treatment. Men diagnosed with low-risk prostate cancer (Gleason Grade Group 1) and currently monitored without active treatment might be suitable candidates. The trial also collects blood samples for future research on potential new cancer markers. As an unphased trial, it offers participants the chance to contribute to research that could enhance future prostate cancer monitoring techniques.

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 prior data suggests that micro-ultrasound imaging is safe for prostate cancer detection?

Research shows that high-resolution micro-ultrasound is a promising tool for imaging prostate cancer. Studies have demonstrated that it provides clear, detailed images in real-time, aiding in the detection of significant prostate cancer. Micro-ultrasound has proven to be as effective as MRI in identifying important cases of prostate cancer, making it a dependable option.

Regarding safety, no specific reports link negative effects directly to micro-ultrasound in the sources provided. This non-invasive imaging method is generally easy for patients to tolerate. Since the trial is in a "Not Applicable" phase, it likely focuses on comparing imaging techniques rather than testing a new drug or treatment, suggesting minimal safety concerns.

Overall, current research indicates that micro-ultrasound is a safe and effective method for detecting prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using high-resolution micro-ultrasound for prostate cancer because it offers a more precise imaging technique compared to traditional methods like MRI alone. This approach allows for targeted biopsies by identifying regions of interest with greater clarity, potentially leading to more accurate diagnosis. Additionally, combining micro-ultrasound with MRI guidance in a single session could streamline the biopsy process, making it more efficient and less invasive for patients. This innovation represents a step forward in enhancing the accuracy and effectiveness of prostate cancer detection.

What evidence suggests that micro-ultrasound is effective for detecting prostate cancer?

Research has shown that high-resolution micro-ultrasound effectively detects prostate cancer. Studies have found its clarity comparable to MRI, a common diagnostic tool for prostate cancer. Sometimes, micro-ultrasound can even provide faster results. In this trial, participants will undergo a combined MRI and micro-ultrasound guided prostate biopsy. An international study found that biopsies using micro-ultrasound technology performed as well as those using MRI, making it a promising option for detecting significant cases of prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Adam Kinnaird, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06626022

NCT06626022 | Screening for Prostate Cancer Using High ... The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy. Official Title. A Phase 3, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12299324/

Micro-Ultrasound in the Detection of Clinically Significant ... ... micro-ultrasound (micro-US) has emerged as a novel high-resolution imaging modality for prostate cancer detection. Unlike conventional ultrasound, which ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143925000870

Clinical-Prostate cancer Diagnostic performance of high ... The aim of this study was to evaluate the diagnostic outcomes of MRI-ultrasound fusion targeted biopsy in detecting clinically significant prostate cancer ( ...

4. eaucongress.uroweb.org eaucongress.uroweb.org/eau25-press-release-high-resolution-ultrasound-could-enable-faster-prostate-cancer-diagnosis/

High resolution ultrasound could enable faster prostate ... Biopsies guided by high-resolution ultrasound are as effective as those using MRI in diagnosing prostate cancer, an international clinical trial has shown.

5. exactimaging.com exactimaging.com/exactvu-micro-ultrasound-system

ExactVu™ Micro-Ultrasound System A revolution in ultrasound, operating at 29 MHz. Micro-ultrasound resolution is comparable to MRI and 300% improvement · Unmatched real-time resolution

6. mdpi.com mdpi.com/2379-139X/11/7/80

Micro-Ultrasound in the Detection of Clinically Significant ... Micro-US consistently demonstrated non-inferiority to mpMRI for csPCa detection across retrospective studies, prospective cohorts, and meta-analyses.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322825/

Micro-Ultrasound: a way to bring imaging for prostate ... Microultrasound presents a promising technology for further improving urological imaging and allows for the possibility of returning prostate cancer imaging to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107814392500345X

Microultrasound-targeted biopsies in patients with ... Background. Microultrasound (microUS) is an emerging imaging modality that enables real-time, high-resolution prostate cancer detection.