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?

This trial aims to determine if a new imaging technique, micro-ultrasound (microUS), matches the effectiveness of the currently used MRI (Magnetic Resonance Imaging) for examining the prostate gland. Researchers will divide participants into two groups to compare MRI and microUS results in guiding prostate biopsy decisions. Men who have never had a prostate biopsy but exhibit certain symptoms, such as a PSA level between 3-20 or an abnormal digital rectal exam (DRE), might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking advancement in prostate imaging.

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.

What prior data suggests that micro-ultrasound is safe for prostate cancer screening?

Research has shown that micro-ultrasound (ExactVu) is a promising tool for examining the prostate. One study compared it to MRI and found that patients generally tolerate micro-ultrasound well. Reports of negative side effects are few, making it a safe option for prostate checks.

Micro-ultrasound is currently undergoing testing in a Phase 3 study, indicating its safety has been demonstrated in earlier tests.

MRI, by contrast, is a well-known and widely used imaging method. It has a strong safety record, with most patients experiencing few or no side effects.

Overall, both micro-ultrasound and MRI are considered safe for prostate cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could transform how prostate cancer is screened. Unlike the standard MRI screening, which can be expensive and time-consuming, micro-ultrasound offers a potentially faster and more cost-effective option. This new technique boasts a higher resolution imaging capability, allowing for a more detailed view of the prostate. If successful, micro-ultrasound could lead to more accurate and earlier detection of prostate cancer, making it a groundbreaking development in the field.

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

This trial will compare the ExactVu micro-ultrasound system with MRI for prostate cancer screening. Research has shown that the ExactVu micro-ultrasound system holds promise for detecting prostate cancer. Studies have found that micro-ultrasound allows doctors to see more details in the prostate, improving diagnostic accuracy. It effectively identifies most prostate cancer cases, though it may occasionally suggest cancer when none is present. The FDA and Health Canada have approved the system, indicating its effectiveness. While MRI is the current standard tool, micro-ultrasound might be equally effective in helping doctors decide if a biopsy is necessary. ^{1 6 7 8 9}

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

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]

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]

Citations

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

Micro-Ultrasound in the Detection of Clinically Significant ... Exact Imaging's ExactVu 29 MHz micro-US system is currently the only clinically studied micro-US platform for the detection of csPCa, with its first adoption by ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143925001176

Enhanced diagnostic accuracy of micro-ultrasound in ... All patients underwent imaging with the ExactVu system, followed by both microUS-targeted and MRI-targeted biopsies. The primary outcome was the accuracy of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06626022

NCT06626022 | Screening for Prostate Cancer Using High ... 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 ...

4. exactimaging.com exactimaging.com/papers-and-publications

Papers and Posters Listing of published peer-reviewed clinical papers and scientific posters citing the ExactVu micro-ultrasound system for prostate imaging and guided biopsy.

5. link.springer.com link.springer.com/article/10.1007/s00261-025-05218-x

a systematic review and diagnostic test accuracy meta ... Micro-US shows high sensitivity but low specificity for classifying clinically significant prostate cancer, resulting in modest overall ...

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

Micro-Ultrasound in the Detection of Clinically Significant ... Micro-Ultrasound in the Detection of Clinically Significant Prostate Cancer: A Comprehensive Review and Comparison with Multiparametric MRI.

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

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

8. exactimaging.com exactimaging.com/images/manuals/English/ExactVu%20Operation%20and%20Safety%20Manual%20(PN%206746)%20Rev%203.7.pdf

ExactVu High Resolution Micro-Ultrasound System ... • Image the prostate, optimize the image and align the micro-ultrasound image with the MRI study data with the prostate mid-line (i.e., the urethra), and ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209454

Prostate Cancer Screening with PSA and MRI Followed by ... The primary outcome was clinically insignificant prostate cancer, defined as a Gleason score of 3+3. The secondary outcome was clinically ...