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
NA
134 participants
INTERVENTIONAL
2014-11-30
2016-09-30
Brief Summary
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The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.
An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.
SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.
This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Biopsy
Single Arm Study. Biopsy Intervention.
SmartTarget - Biopsy
MRI to ultrasound fusion guided prostate biopsy
Interventions
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SmartTarget - Biopsy
MRI to ultrasound fusion guided prostate biopsy
Eligibility Criteria
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Inclusion Criteria
* Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
* An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
* Signed informed consent
Exclusion Criteria
* Men with an irreversible coagulopathy predisposing to bleeding
* Men who are unability to undergo transrectal ultrasonography
* Men who have had previous radiation therapy to the pelvis
* Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
* Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* Men who are unable to give informed consent
MALE
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Hashim U Ahmed, FRCS PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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University College London
London, , United Kingdom
Countries
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Other Identifiers
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14/0044
Identifier Type: -
Identifier Source: org_study_id
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