PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures
NCT ID: NCT02936258
Last Updated: 2018-02-22
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
NA
450 participants
INTERVENTIONAL
2016-11-30
2019-11-30
Brief Summary
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Detailed Description
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An alternative pathway for prostate cancer diagnosis in men with elevated PSA is to perform multi-parametric magnetic resonance imaging (MPMRI) to localize cancer. This information is used to direct a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar or greater amount of clinically significant cancer than systematic TRUS guided biopsy and has several other potential advantages including: the ability to differentiate between clinically significant and insignificant cancer, reducing unnecessary biopsy and fewer numbers of biopsy cores, reducing biopsy-related side-effects.
A 'clinically insignificant cancer' is cancer that is unlikely to progress or to affect an individual's life expectancy and therefore does not warrant treatment. However when diagnosed with low grade cancer that is likely to be insignificant, a large proportion of subjects request treatment in case a more significant cancer is present. A challenge in this area is that subjects are typically not aware that their cancer is clinically insignificant, and often view the early diagnosis and aggressive treatment they have been subjected to as life-saving.
A prostate cancer detection procedure that differentiates clinically significant cancer from clinically insignificant cancer is therefore a major unmet need.
The potential implications of this trial include:
* A redefinition of the prostate cancer diagnostic pathway;
* A reduction in the number of subjects undergoing prostate biopsy;
* A reduction in the number of biopsy cores taken per subject;
* A reduction in biopsy-related adverse events including sepsis and pain;
* A reduction in the over-diagnosis of clinically insignificant prostate cancer;
* A reduction in the economic burden of diagnosing and treating prostate cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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MRI
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.
MRI
Men 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.
MRI Targeted Biopsy
Men 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.
Standard of Care
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).
Standard of Care
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).
Interventions
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Standard of Care
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).
MRI
Men 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.
MRI Targeted Biopsy
Men 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.
Eligibility Criteria
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Inclusion Criteria
2. ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp;
3. Serum PSA ≤ 20ng/ml within 3 months of randomization
4. Fit to undergo all procedures listed in protocol;
5. Able to provide written informed consent.
Exclusion Criteria
2. Prior treatment for prostate cancer
3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
4. Contraindication to prostate biopsy
5. Men in whom artifact would reduce the quality of the MRI, i.e. previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
6. Unfit to undergo any procedures listed in protocol.
18 Years
MALE
No
Sponsors
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Ontario Institute for Cancer Research
OTHER
Prostate Cancer Canada
OTHER
Canadian Urology Research Consortium
OTHER
Responsible Party
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Locations
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Vancouver Prostate Centre
Vancouver, British Columbia, Canada
London Health Sciences Centre-Victoria Hospital
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CIUSSS du Centre-Ouest-de-I'ile-de-Montreal-Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Machado A, Levental M, Ghai S, Chang SD, Patel C, Kassam Z, Loblaw A, Kebabdjian M, Pond G, Haider MA. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of a Prospective Randomized Trial (PRECISE). Eur Urol Oncol. 2024 Jun;7(3):456-461. doi: 10.1016/j.euo.2023.09.013. Epub 2023 Oct 12.
Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Bladou F, Mercado A, Levental M, Ghai S, Chang SD, Milot L, Patel C, Kassam Z, Moore C, Kasivisvanathan V, Loblaw A, Kebabdjian M, Earle CC, Pond GR, Haider MA. Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):534-542. doi: 10.1001/jamaoncol.2020.7589.
Other Identifiers
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PRECISE Trial
Identifier Type: -
Identifier Source: org_study_id
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