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MRI for Prostate Cancer (PRECISE Trial)
N/A
Waitlist Available
Research Sponsored by Canadian Urology Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MRI-The proportion of men with clinically significant cancer (Gleason > 7)
Secondary study objectives
Biopsy-The proportion of men with clinically significant cancer (Gleason ≥7)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MRIExperimental Treatment2 Interventions
Men in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years.
Group II: Standard of CareActive Control1 Intervention
Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1620
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Who is running the clinical trial?
Prostate Cancer CanadaOTHER
9 Previous Clinical Trials
7,076 Total Patients Enrolled
6 Trials studying Prostate Cancer
6,832 Patients Enrolled for Prostate Cancer
Canadian Urology Research ConsortiumLead Sponsor
6 Previous Clinical Trials
741 Total Patients Enrolled
4 Trials studying Prostate Cancer
415 Patients Enrolled for Prostate Cancer
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
8,723 Total Patients Enrolled
2 Trials studying Prostate Cancer
580 Patients Enrolled for Prostate Cancer
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