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This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined MRI and micro-ultrasound guided prostate biopsy. | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution micro-ultrasound | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer upgrading during Active surveillance by micro-ultrasound and MRI | The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy. | Immediately after biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy. | Secondary outcome will compare each imaged-guided biopsy technique to the standard-of-care 12 core systematic biopsy simultaneously obtained. | Immediately after biopsy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Kinnaird, MD, PhD | Contact | 780-407-5800 | 321 | ask@ualberta.ca |
| Stacey Broomfield, PhD | Contact | 780-407-5800 | 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, Department of Urology | Recruiting | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Prospective paired diagnostic trial
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| Kipnes Urology Centre - Kaye Edmonton Clinic | Recruiting | Edmonton | Alberta | T6G1Z1 | Canada |
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| University of British Columbia | Recruiting | Vancouver | Alberta | V6T 1Z3 | Canada |
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| CIUSSS du Nord-de-L'Ile-De-Montreal | Recruiting | Montreal | Quebec | H3L 1K5 | Canada |
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| University Hospital Centre Zagreb | Recruiting | Zagreb | Croatia |
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| Humanitas | Recruiting | Milan | Italy |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |