Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
250 participants
INTERVENTIONAL
2011-11-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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TRUS guided biopsy
No interventions assigned to this group
MRI Assisted TRUS guided biopsy
MRI assisted TRUS guided biopsy
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
Interventions
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MRI assisted TRUS guided biopsy
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
Eligibility Criteria
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Inclusion Criteria
* candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
* Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
* Clinical (diagnostic biopsy) Gleason sum \< 6
* PSA \< 10.0 ng/ml (ug/L)
Exclusion Criteria
* Planned anti-androgen therapy
* Inability to undergo TRUS biopsy
* Inability to undergo multi-parametric MRI
18 Years
MALE
No
Sponsors
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Ontario Institute for Cancer Research
OTHER
Eigen
OTHER
Canadian Urology Research Consortium
OTHER
Responsible Party
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Principal Investigators
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Laurence Klotz, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Urology Research Consortium
Locations
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London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
Other Identifiers
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CURC-003
Identifier Type: -
Identifier Source: org_study_id
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