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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI | Active Comparator |
| |
| microUltransound | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | Standard prostate mpMRI. |
| |
| ExactVu |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Once enrolled, men will be followed for 1 year after the imaging test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacey Broomfield, PhD | Contact | +1-780-407-5800 | 321 | sbroomfi@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Adam Kinnaird, MD, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles (UCLA) | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Device |
microUltrasound |
|
| UT Southwestern Medical Center | Not yet recruiting | Dallas | Texas | 75390 | United States |
|
| University of Alberta | Active, not recruiting | Edmonton | Alberta | T6G 1Z1 | Canada |
| University of British Columbia | Not yet recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
|
| CIUSSS du Nord-de-l'Île-de-Montréal | Not yet recruiting | Montréal | Quebec | H4J 1C5 | Canada |
|
| CH de Martigues | Recruiting | Martigues | France |
|
| Vestfold Hospital Trust | Recruiting | Tønsberg | Norway |
|
| Urologia Clinica Bilbao | Recruiting | Bilbao | Spain |
|