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| Name | Class |
|---|---|
| Ontario Institute for Cancer Research | OTHER |
| Eigen | OTHER |
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This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRUS guided biopsy | No Intervention | ||
| MRI Assisted TRUS guided biopsy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI assisted TRUS guided biopsy | Device | All subjects to have a confirmatory biopsy at one year. Those assigned ARM 1 to have a TRUS guided biopsy and those assigned to ARM 2to have a MRI assisted TRUS guided biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher | one year |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher | one year |
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Inclusion Criteria:
histological confirmation of adenocarcinoma of the prostate
candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Klotz, MD | Canadian Urology Research Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada | ||
| Sunnybrook Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31708295 | Derived | Klotz L, Pond G, Loblaw A, Sugar L, Moussa M, Berman D, Van der Kwast T, Vesprini D, Milot L, Kebabdjian M, Fleshner N, Ghai S, Chin J, Haider M. Randomized Study of Systematic Biopsy Versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-year Postbiopsy Follow-up. Eur Urol. 2020 Mar;77(3):311-317. doi: 10.1016/j.eururo.2019.10.007. Epub 2019 Nov 8. | |
| 30017404 |
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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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| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Derived |
| Klotz L, Loblaw A, Sugar L, Moussa M, Berman DM, Van der Kwast T, Vesprini D, Milot L, Kebabdjian M, Fleshner N, Ghai S, Chin J, Pond GR, Haider M. Active Surveillance Magnetic Resonance Imaging Study (ASIST): Results of a Randomized Multicenter Prospective Trial. Eur Urol. 2019 Feb;75(2):300-309. doi: 10.1016/j.eururo.2018.06.025. Epub 2018 Jul 13. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |