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OpenTrials
Completed

NCT Number: NCT02341677

SmartTarget: BIOPSY

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

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Key information

Conditions

Prostatic Neoplasms Diagnostic Techniques and Procedures Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartTarget - Biopsy

Procedure

MRI to ultrasound fusion guided prostate biopsy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 19, 2015
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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