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SmartTarget THERAPY

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290561
Recruitment Status : Unknown
Verified November 2014 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
University College, London

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


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: SmartTarget Therapy Device: MRI Device: high intensity focused ultrasound (HIFU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy
Study Start Date : December 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: SmartTarget Therapy
    MRI to Ultrasound fusion directed HIFU
  • Device: MRI
  • Device: high intensity focused ultrasound (HIFU)


Primary Outcome Measures :
  1. Target Ablation [ Time Frame: 1 week post treatment ]
    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 :
  1. Accuracy [ Time Frame: 1 week post treatment ]
    The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment.

  2. Length of the procedure [ Time Frame: intraoperative ]

    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


  3. Quality of Life [ Time Frame: 6 weeks and 3 months ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290561


Contacts
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Contact: Ian A Donaldson, BMBS MRCS 0044 (0)207 679 9092 i.donaldson@ucl.ac.uk

Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Hashim U Ahmed, FRCS PhD University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02290561    
Other Study ID Numbers: 14/0389
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by University College, London:
Prostatic Neoplasms
Therapeutics
Magnetic Resonance Imaging
Ultrasonography
High Intensity Focused Ultrasound
Image Fusion
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases