SmartTarget: BIOPSY

January 29, 2019 updated by: University College, London

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 weeks of biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 3 weeks of Biopsy
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
During Procedure
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
6 Weeks post biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Hashim U Ahmed, FRCS PhD, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/0044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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