Imaging for Significant Prostate Cancer Risk Evaluation
NCT ID: NCT01492270
Last Updated: 2011-12-30
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
126 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
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Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.
An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.
The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.
The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Prostate HistoScanning
Advanced Ultrasound assessment of the prostate
Multi-parametric MRI
Multi-sequence Magnetic resonance imaging of the prostate
Transperineal prostate mapping biopsy
Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.
Image guided biopsies
Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy.
Exclusion Criteria
* Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.
* Men unable to have general or regional anaesthesia
* Men unable to give informed consent
20 Years
MALE
No
Sponsors
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Advanced Medical Diagnostics s.a.
INDUSTRY
University College London Hospitals
OTHER
Responsible Party
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Professor Mark Emberton
Professor of Interventional Oncology
Principal Investigators
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Mark Emberton, MBBS,MD,FRCS
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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University College London Hospitals
London, London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Lucy AM Simmons, MBBS, MRCS
Role: primary
Hashim Uddin Ahmed, MBBS, MRCS
Role: backup
References
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Simmons LAM, Kanthabalan A, Arya M, Briggs T, Charman SC, Freeman A, Gelister J, Jameson C, McCartan N, Moore CM, van der Muelen J, Emberton M, Ahmed HU. Prostate Imaging Compared to Transperineal Ultrasound-guided biopsy for significant prostate cancer Risk Evaluation (PICTURE): a prospective cohort validating study assessing Prostate HistoScanning. Prostate Cancer Prostatic Dis. 2019 May;22(2):261-267. doi: 10.1038/s41391-018-0094-1. Epub 2018 Oct 2.
Simmons LAM, Kanthabalan A, Arya M, Briggs T, Barratt D, Charman SC, Freeman A, Hawkes D, Hu Y, Jameson C, McCartan N, Moore CM, Punwani S, van der Muelen J, Emberton M, Ahmed HU. Accuracy of Transperineal Targeted Prostate Biopsies, Visual Estimation and Image Fusion in Men Needing Repeat Biopsy in the PICTURE Trial. J Urol. 2018 Dec;200(6):1227-1234. doi: 10.1016/j.juro.2018.07.001. Epub 2018 Jul 11.
Miah S, Eldred-Evans D, Simmons LAM, Shah TT, Kanthabalan A, Arya M, Winkler M, McCartan N, Freeman A, Punwani S, Moore CM, Emberton M, Ahmed HU. Patient Reported Outcome Measures for Transperineal Template Prostate Mapping Biopsies in the PICTURE Study. J Urol. 2018 Dec;200(6):1235-1240. doi: 10.1016/j.juro.2018.06.033. Epub 2018 Jun 27.
Other Identifiers
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11/LO/1657
Identifier Type: -
Identifier Source: org_study_id