PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not?
NCT ID: NCT02380027
Last Updated: 2018-05-01
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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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
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We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.
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Detailed Description
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An alternative pathway for the diagnosis of prostate cancer in men with raised prostate specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use this information to influence conduct of a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount of clinically significant cancer to TRUS-biopsy but may have several advantages, for example in reducing the number of men who require biopsy.
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's life expectancy and therefore does not warrant treatment. However when diagnosed with insignificant cancer a large proportion of patients request treatment in case a more significant cancer is present. A prostate cancer detection pathway that finds significant cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.
The potential implications of this trial include:
* A redefining of the prostate cancer diagnostic pathway
* A reduction in the number of patients undergoing prostate biopsy
* A reduction in the number of biopsy cores taken per patient
* A reduction in biopsy-related sepsis, pain and other side effects
* A reduction in the over-diagnosis of clinically insignificant prostate cancer
* A reduction of the economic burden of diagnosing and treating prostate cancer
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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MRI-arm
Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.
MRI
This will be a multi-parametric MRI of the prostate
MRI-targeted biopsy
This will be a biopsy targeted to suspicious areas on the MRI
TRUS-biopsy arm
Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy
TRUS-biopsy
This will be a standard 12 core trans-rectal prostate biopsy
Interventions
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MRI
This will be a multi-parametric MRI of the prostate
MRI-targeted biopsy
This will be a biopsy targeted to suspicious areas on the MRI
TRUS-biopsy
This will be a standard 12 core trans-rectal prostate biopsy
Eligibility Criteria
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Inclusion Criteria
2. Serum PSA ≤ 20ng/ml within the previous 3 months
3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
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 glomerular filtration rate ≤ 50mls/min)
4. Contraindication to prostate biopsy
5. Men in whom artifact would reduce the quality of the MRI
6. Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
7. Unfit to undergo any procedures listed in protocol
18 Years
MALE
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University Hospital, Lille
OTHER
Radboud University Medical Center
OTHER
London North West Healthcare NHS Trust
OTHER
Royal Free Hospital NHS Foundation Trust
OTHER
Sunnybrook Health Sciences Centre
OTHER
University College London Hospitals
OTHER
University Ghent
OTHER
Helsinki University Central Hospital
OTHER
Jewish General Hospital
OTHER
University of Roma La Sapienza
OTHER
Göteborg University
OTHER
Erasmus Medical Center
OTHER
Hunter Holmes Mcguire Veteran Affairs Medical Center
FED
University Hospital Heidelberg
OTHER
University Hospital, Aachen
OTHER
Hampshire Hospitals NHS Foundation Trust
OTHER
Princess Alexandra Hospital NHS Trust
OTHER
San Raffaele University Hospital, Italy
OTHER
M.D. Anderson Cancer Center
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
University of Oulu
OTHER
The Whittington Hospital NHS Trust
OTHER_GOV
University Hospital of Cologne
OTHER
Mayo Clinic
OTHER
Centro de Urologia Argentina
UNKNOWN
Weill Medical College of Cornell University
OTHER
University of Chicago
OTHER
University Hospital, Bordeaux
OTHER
University College, London
OTHER
Responsible Party
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Veeru Kasivisvanathan
Study Coordinator
Principal Investigators
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Caroline Moore, MD FRCS
Role: STUDY_CHAIR
University College Hospital London and University College London
Mark Emberton, MD FRCS
Role: STUDY_CHAIR
University College Hospital London and University College London
Locations
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University College Hospitals
London, , United Kingdom
Countries
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References
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Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
Kasivisvanathan V, Jichi F, Klotz L, Villers A, Taneja SS, Punwani S, Freeman A, Emberton M, Moore CM. A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol. BMJ Open. 2017 Oct 12;7(10):e017863. doi: 10.1136/bmjopen-2017-017863.
Other Identifiers
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DRF-2014-07-146
Identifier Type: -
Identifier Source: org_study_id
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