SmartTarget THERAPY

Study Overview
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Brief Summary
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The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate. The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue. Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects. SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation. The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan

Official Title
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SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Procedure: SmartTarget Therapy
* Device: MRI
* Device: high intensity focused ultrasound (HIFU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of prostate cancer (PSA </=15ng/ml, Gleason score </=4+3, and radiological stage </=T3aNoMo) Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only) Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T An understanding of the English language sufficient to understand written and verbal information about the trial and consent process Signed informed consent Exclusion Criteria: No lesion on mpMRI Bilateral lesions on mpMRI mpMRI undertaken over 6 months prior to visit 1 Contralateral Gleason >/=3+4 and/or Maximum Cancer Core Length Involvement >/=6mm Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months Prior immunosuppression or predefined immunosuppressed state An irreversible coagulopathy predisposing to bleeding Unable to undergo transrectal ultrasonography Previous radiation therapy to the pelvis Previous HIFU, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging Men not fit for major surgery as assessed by a consultant anaesthetist Men who are unable to give informed consent
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SmartTarget Therapy|MRI to Ultrasound fusion directed HIFU|
|Device: MRI|nan|
|Device: high intensity focused ultrasound (HIFU)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Ablation | The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist. | 1 week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment. | 1 week post treatment | 
| Length of the procedure | The efficiency and clinical usability of the SmartTarget device as measured by the: Length of the procedure The time taken during the procedure using SmartTarget, including: The total prostate computer model generation time The total time taken to register (fuse) MRI and ultrasound image data and the number of times an image registration is performed using SmartTarget (the re-registration rate) SmartTarget failure rate | intraoperative | 
| Quality of Life | To assess how this treqatment strategy impacts on quality of life as measured using validated questionnaires at 6 weeks and 3 months post treatment. IPSS IIEF EQ5D - 5L | 6 weeks and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Therapeutics, Magnetic Resonance Imaging, Ultrasonography, High Intensity Focused Ultrasound, Image Fusion