SmartTarget THERAPY
Primary Purpose
Prostatic Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SmartTarget Therapy
MRI
high intensity focused ultrasound (HIFU)
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Therapeutics, Magnetic Resonance Imaging, Ultrasonography, High Intensity Focused Ultrasound, Image Fusion
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Accuracy
The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one 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
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
Full Information
NCT ID
NCT02290561
First Posted
November 10, 2014
Last Updated
November 13, 2014
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT02290561
Brief Title
SmartTarget THERAPY
Official Title
SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic Neoplasms, Therapeutics, Magnetic Resonance Imaging, Ultrasonography, High Intensity Focused Ultrasound, Image Fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
SmartTarget Therapy
Intervention Description
MRI to Ultrasound fusion directed HIFU
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Type
Device
Intervention Name(s)
high intensity focused ultrasound (HIFU)
Primary Outcome Measure Information:
Title
Target Ablation
Description
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.
Time Frame
1 week post treatment
Secondary Outcome Measure Information:
Title
Accuracy
Description
The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment.
Time Frame
1 week post treatment
Title
Length of the procedure
Description
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
Time Frame
intraoperative
Title
Quality of Life
Description
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
Time Frame
6 weeks and 3 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian A Donaldson, BMBS MRCS
Phone
0044 (0)207 679 9092
Email
i.donaldson@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim U Ahmed, FRCS PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
SmartTarget THERAPY
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