An interventional study of SmartTarget - Biopsy in Prostatic Neoplasms and Diagnostic Techniques and Procedures, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to male participants. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by University College, London · Not applicable, Interventional, and Diagnostic
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
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 134 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Single Arm Study. Biopsy Intervention.
Procedure: SmartTarget - Biopsy
MRI to ultrasound fusion guided prostate biopsy
Cancer Detection
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.
Time frame: Within 3 weeks of biopsy
Targeting Efficiency (core length, grade)
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
Time frame: Within 3 weeks of Biopsy
Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)
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
Time frame: During Procedure
Quality of Life
To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires: IPSS IIEF EQ5D - 5L
Time frame: 6 Weeks post biopsy
Ran from Nov 2014 to primary completion in Sep 2016, 22 months.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's 22 months is below that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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