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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartTarget Therapy | Procedure | MRI to Ultrasound fusion directed HIFU | ||
| MRI | Device | |||
| high intensity focused ultrasound (HIFU) | Device |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ian A Donaldson, BMBS MRCS | Contact | 0044 (0)207 679 9092 | i.donaldson@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Hashim U Ahmed, FRCS PhD | University College, London | Principal Investigator |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |