SmartTarget: BIOPSY
- Conditions
- Prostatic NeoplasmsDiagnostic Techniques and Procedures
- Interventions
- Procedure: SmartTarget - Biopsy
- Registration Number
- NCT02341677
- Lead Sponsor
- University College, London
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 134
- Previous TRUS biopsy with clinical indication for repeat biopsy
- 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
- Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Biopsy SmartTarget - Biopsy Single Arm Study. Biopsy Intervention.
- Primary Outcome Measures
Name Time Method Cancer Detection 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.
- Secondary Outcome Measures
Name Time Method Targeting Efficiency (core length, grade) 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 CancerQuality of Life 6 Weeks post biopsy To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires:
IPSS IIEF EQ5D - 5LClinical Usability (length of procedure, generation time, re-registration rate, failure rate) 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
Trial Locations
- Locations (1)
University College London
🇬🇧London, United Kingdom