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|ClinicalTrials.gov Identifier: NCT02341677|
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : January 31, 2019
The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.
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
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Diagnostic Techniques and Procedures||Procedure: SmartTarget - Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Single Arm Study. Biopsy Intervention.
Procedure: SmartTarget - Biopsy
MRI to ultrasound fusion guided prostate biopsy
- Cancer Detection [ Time Frame: Within 3 weeks of biopsy ]The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.
- Targeting Efficiency (core length, grade) [ Time Frame: Within 3 weeks of Biopsy ]
The targeting efficiency of the SmartTarget guided biopsies versus visually-directed biopsies measured by:
Number of cores required to obtain the highest cancer risk category Number of cores with cancer Maximum Cancer Core Length and Total Cancer Core Length Highest Grade Cancer
- Clinical Usability (length of procedure, generation time, re-registration rate, failure rate) [ Time Frame: During Procedure ]
To evaluate the clinical usability of SmartTarget guided biopsy as measured by:
Length of Procedure SmartTarget model generation time SmartTarget re-registration rate SmartTarget failure rate
- Quality of Life [ Time Frame: 6 Weeks post biopsy ]
To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires:
IPSS IIEF EQ5D - 5L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341677
|University College London|
|London, United Kingdom|
|Principal Investigator:||Hashim U Ahmed, FRCS PhD||University College, London|