Micro-ultrasound vs MRI for Prostate Cancer Screening

(MUSIC-Screen Trial)

Recruiting at 3 trial locations

Overseen By Adam Kinnaird, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Alberta

Must not be taking: Testosterone, Androgen therapy

Disqualifiers: Prostate cancer, Prior imaging, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

1284 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you've had testosterone replacement or androgen deprivation therapy in the last 12 months.

Is micro-ultrasound safe for prostate cancer screening?

The ExactVu micro-ultrasound system is approved by the FDA, CE, and Health Canada for visualizing and biopsying the prostate, indicating it meets safety standards for these procedures. ^{1 2 3 4 5}

How does the treatment using micro-ultrasound differ from MRI for prostate cancer screening?

Micro-ultrasound is a new imaging technology that uses high-frequency sound waves to create detailed images of the prostate, offering a simpler, more accessible, and potentially less expensive alternative to MRI. Unlike MRI, which requires specialized expertise and equipment, micro-ultrasound can be performed in real-time by urologists, making it a promising tool for detecting and monitoring prostate cancer. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment ExactVu, MRI, Magnetic Resonance Imaging for prostate cancer screening?

Research shows that high-resolution micro-ultrasound, like ExactVu, can effectively detect prostate cancer by identifying changes in the prostate's structure, similar to MRI. It offers advantages such as being more affordable and easier to access compared to traditional MRI, while still providing reliable detection of significant prostate cancer. ^{5 7 11 12 13}

Are You a Good Fit for This Trial?

This trial is for individuals who need screening for prostate cancer. Participants should be eligible and considering a prostate biopsy based on current medical guidelines. The study excludes those with contraindications to MRI, previous reactions to contrast agents used in MRI, or any condition that would interfere with micro-ultrasound imaging.

Inclusion Criteria

Biopsy naïve

I am between 50 and 70 years old.

My PSA levels are between 3-20, or I had an abnormal DRE result.

Exclusion Criteria

Prior prostate imaging using microUS or MRI

Contraindication to microUS or MRI

I have had prostate cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo imaging using either microUS or MRI to compare effectiveness in detecting prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for detection of clinically significant prostate cancer

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ExactVu
• MRI

Trial Overview The study compares two types of imaging: traditional MRI and a new technique called ExactVu micro-ultrasound (microUS). Patients will be randomly assigned to one of the two methods to determine which is more effective at identifying abnormalities that may require a biopsy.

How Is the Trial Designed?

Group I: microUltransound Experimental Treatment 1 Intervention

Group II: MRI Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

High-resolution micro-ultrasound demonstrated a higher sensitivity (94%) for detecting clinically significant prostate cancer compared to multiparametric MRI (90%), suggesting it may be a more effective imaging option.

Micro-ultrasound offers a low-cost and accessible alternative for prostate cancer screening and targeted biopsy, with similar specificity to mpMRI, making it a promising tool for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. Klotz, L., Lughezzani, G., Maffei, D., et al.[2022]

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]

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]

Citations

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

Comparison of Initial Experience with Transrectal Magnetic Resonance Imaging Cognitive Guided Micro-Ultrasound Biopsies versus Established Transperineal Robotic Ultrasound Magnetic Resonance Imaging Fusion Biopsies for Prostate Cancer. [2020]

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

Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A non-inferiority comparative analysis of micro-ultrasonography and MRI-targeted biopsy in men at risk of prostate cancer. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Role of prostate MRI, TRUS fusion biopsies and new markers in the diagnostic strategy of prostate cancer]. [2017]

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

Diagnostic Accuracy of a Rapid Biparametric MRI Protocol for Detection of Histologically Proven Prostate Cancer. [2023]

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

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

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

Do cancer detection rates differ between transperineal and transrectal micro-ultrasound mpMRI-fusion-targeted prostate biopsies? A propensity score-matched study. [2023]

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

Comparison of Micro-US and Multiparametric MRI for Prostate Cancer Detection in Biopsy-Naive Men. [2023]

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

Active Surveillance for Prostate Cancer: Expanding the Role of MR Imaging and the Use of PRECISE Criteria. [2023]

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

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

11. Canada pubmed.ncbi.nlm.nih.gov

Comparison of conventional transrectal ultrasound, magnetic resonance imaging, and micro-ultrasound for visualizing prostate cancer in an active surveillance population: A feasibility study. [2020]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Micro-Ultrasound: a way to bring imaging for prostate cancer back to urology. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Micro-Ultrasound: Current Role in Prostate Cancer Diagnosis and Future Possibilities. [2023]