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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
University College, London
About
Eligibility
Locations
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histological diagnosis of prostate cancer (PSA </=15ng/ml, Gleason score </=4+3, and radiological stage </=T3aNoMo)
  2. Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only)
  3. Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion
  4. mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T
  5. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
  6. Signed informed consent

Exclusion Criteria:

  1. No lesion on mpMRI
  2. Bilateral lesions on mpMRI
  3. mpMRI undertaken over 6 months prior to visit 1
  4. Contralateral Gleason >/=3+4 and/or Maximum Cancer Core Length Involvement >/=6mm
  5. Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
  6. Prior immunosuppression or predefined immunosuppressed state
  7. An irreversible coagulopathy predisposing to bleeding
  8. Unable to undergo transrectal ultrasonography
  9. Previous radiation therapy to the pelvis
  10. Previous HIFU, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate.
  11. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
  12. Men not fit for major surgery as assessed by a consultant anaesthetist
  13. 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

    First Posted
    November 10, 2014
    Last Updated
    November 13, 2014
    Sponsor
    University College, London
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    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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