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SmartTarget: BIOPSY

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ClinicalTrials.gov Identifier: NCT02341677
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.

The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.

An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.

SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.

This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Diagnostic Techniques and Procedures Procedure: SmartTarget - Biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy
Actual Study Start Date : November 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Biopsy
Single Arm Study. Biopsy Intervention.
Procedure: SmartTarget - Biopsy
MRI to ultrasound fusion guided prostate biopsy




Primary Outcome Measures :
  1. Cancer Detection [ Time Frame: Within 3 weeks of biopsy ]
    The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.


Secondary Outcome Measures :
  1. Targeting Efficiency (core length, grade) [ Time Frame: Within 3 weeks of Biopsy ]

    The targeting efficiency of the SmartTarget guided biopsies versus visually-directed biopsies measured by:

    Number of cores required to obtain the highest cancer risk category Number of cores with cancer Maximum Cancer Core Length and Total Cancer Core Length Highest Grade Cancer


  2. Clinical Usability (length of procedure, generation time, re-registration rate, failure rate) [ Time Frame: During Procedure ]

    To evaluate the clinical usability of SmartTarget guided biopsy as measured by:

    Length of Procedure SmartTarget model generation time SmartTarget re-registration rate SmartTarget failure rate


  3. Quality of Life [ Time Frame: 6 Weeks post biopsy ]

    To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires:

    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:

  • Previous TRUS biopsy with clinical indication for repeat biopsy
  • Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
  • An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
  • Signed informed consent

Exclusion Criteria:

  • Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
  • Men with an irreversible coagulopathy predisposing to bleeding
  • Men who are unability to undergo transrectal ultrasonography
  • Men who have had previous radiation therapy to the pelvis
  • Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
  • Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
  • 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): NCT02341677


Locations
United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Hashim U Ahmed, FRCS PhD University College, London

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02341677     History of Changes
Other Study ID Numbers: 14/0044
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Keywords provided by University College, London:
Prostatic Neoplasms
Diagnostic Techniques and Procedures
Magnetic Resonance Imaging
Ultrasonography
Biopsy
Image Fusion

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases