Prostate Cancer ScreeningPhase 3MUSIC-ScreenNCT06626022
Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
A Phase 3 study testing MRI and ExactVu in people with Prostate Cancer Screening, run by University of Alberta at 9 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Screening
- What is being tested?
- MRI and ExactVu
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,284 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 8 May 2025to 30 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex;
- Age 50-70;
- PSA 3-20 and/or abnormal DRE;
- Biopsy naïve.
Who cannot join
- Prior personal history of prostate cancer;
- Prior prostate imaging using microUS or MRI;
- Contraindication to microUS or MRI;
- Testosterone replacement therapy within last 12 months; or
- Androgen deprivation therapy within last 12 months.
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
Canada4 sites, 3 recruiting
- Active, not recruiting
University of Alberta
Edmonton, Alberta, T6G 1Z1
- Not yet recruiting
CIUSSS du Nord-de-l'Île-de-Montréal
Montréal, Quebec, H4J 1C5
Hugo Lavigueur-Blouin, MD, hugo.lavigueur-blouin.med@ssss.gouv.qc.ca
Hugo Lavigueur-Blouin, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Shania Nigli, 416-480-6100 ext. 2890, shania.nigli@sunnybrook.ca
Laurence Klotz, MD
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Miles Mannas, MD, mmannas@mail.ubc.ca
Miles Mannas, MD
United States2 sites, 2 recruiting
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Sonobia Garrett, 214-645-8787, Sonobia.Garrett@UTSouthwestern.edu
Xiaosong Meng, MD, PhD
- Recruiting
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
Ankush Sachdeva, 310-794-3452, ASachdeva@mednet.ucla.edu
Wayne Brisbane, MD
France1 site, 1 recruiting
- Recruiting
CH de Martigues
Martigues
Gwladys M-Bou, MD, 04 42 43 24 69, Gwladys.MBOUNGOU@ch-martigues.fr
Harry Toledano, MD
Norway1 site, 1 recruiting
- Recruiting
Vestfold Hospital Trust
Tønsberg
Sven Loffeler, PhD, MD
Spain1 site, 1 recruiting
- Recruiting
Urologia Clinica Bilbao
Bilbao
Felipe Urdaneta, MD, luisurdaneta03@yahoo.com
Felipe Urdaneta, MD
About this study
Official title: A Phase 3, Multicenter, International, Non-inferiority, Randomized Clinical Trial Comparing Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging (MUSIC-Screen)
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.
- Conditions
- Prostate Cancer Screening
- Being tested
- MRI, ExactVu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Standard prostate mpMRI.
ExactVuDevice
microUltrasound
| Study group | Role | What they receive |
|---|---|---|
| MRI | Active comparator | Not described Receives: Device: MRI |
| microUltransound | Experimental | Not described Receives: Device: ExactVu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Clinically significant prostate cancer.
The primary objective of this trial is to determine if a screening pathway using microUS is non-inferior to a pathway using MRI for the detection of clinically significant prostate cancer, defined as Gleason Grade Group 2 or more.
Measured: Once enrolled, men will be followed for 1 year after the imaging test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start8 May 2025
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Kinnaird, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626022
- Sponsor's protocol ID
- HREBA.CC-24-0325
- Acronym
- MUSIC-Screen
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guer M, Beksac AT, Brisbane W, Cash H, Ghai S, Ghosh S, Heinrichs A, Klotz L, Lavigueur-Blouin H, Loffeler S, Lughezzani G, Mannas M, Meng X, Morgan TN, Nahar B, Rodrigues T, Struck JP, Tiwari R, Toledano H, Urdaneta F, Kinnaird A. Optimizing prostate biopsy decision making - (MUSIC-screen): A 1:1 randomized controlled trial comparing micro-ultrasound versus multiparametric magnetic resonance imaging for prostate cancer diagnosis. Contemp Clin Trials. 2026 Sep;168:108410. doi: 10.1016/j.cct.2026.108410. Epub 2026 Jul 20.
PubMed 42476253
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, International, Non-inferiority, Randomized Clinical Trial Comparing Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging (MUSIC-Screen)
- ClinicalTrials.gov ID
- NCT06626022
- Acronym / sponsor ID
- MUSIC-Screen / HREBA.CC-24-0325
- Conditions
- Prostate Cancer Screening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,284 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI | Active comparator | Device: MRI |
| microUltransound | Experimental | Device: ExactVu |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male sex;
- Age 50-70;
- PSA 3-20 and/or abnormal DRE;
- Biopsy naïve.
Key exclusion criteria (5 listed)
- Prior personal history of prostate cancer;
- Prior prostate imaging using microUS or MRI;
- Contraindication to microUS or MRI;
- Testosterone replacement therapy within last 12 months; or
- Androgen deprivation therapy within last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIStandard prostate mpMRI. | Device | MRI |
| ExactVumicroUltrasound | Device | microUltransound |
Primary outcome
Detection of Clinically significant prostate cancer.
Time frame: Once enrolled, men will be followed for 1 year after the imaging test.
The primary objective of this trial is to determine if a screening pathway using microUS is non-inferior to a pathway using MRI for the detection of clinically significant prostate cancer, defined as Gleason Grade Group 2 or more.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 42476253Guer M, Beksac AT, Brisbane W, Cash H, Ghai S, Ghosh S, Heinrichs A, Klotz L, Lavigueur-Blouin H, Loffeler S, Lughezzani G, Mannas M, Meng X, Morgan TN, Nahar B, Rodrigues T, Struck JP, Tiwari R, Toledano H, Urdaneta F, Kinnaird A. Optimizing prostate biopsy decision making - (MUSIC-screen): A 1:1 randomized controlled trial comparing micro-ultrasound versus multiparametric magnetic resonance imaging for prostate cancer diagnosis. Contemp Clin Trials. 2026 Sep;168:108410. doi: 10.1016/j.cct.2026.108410. Epub 2026 Jul 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Kinnaird, MD, PhD principal investigator
University of Alberta
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRI and ExactVu in people with Prostate Cancer Screening, run by University of Alberta at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United States, France, Norway, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Broomfield, PhD (+1-780-407-5800 ext. 321, sbroomfi@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Clinically significant prostate cancer. (time frame: Once enrolled, men will be followed for 1 year after the imaging test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06626022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.