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SmartTarget: BIOPSY

Primary Purpose

Prostatic Neoplasms, Diagnostic Techniques and Procedures

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

SmartTarget - Biopsy

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Diagnostic Techniques and Procedures, Magnetic Resonance Imaging, Ultrasonography, Biopsy, Image Fusion

Eligibility Criteria

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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

Sites / Locations

University College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy

Arm Description

Single Arm Study. Biopsy Intervention.

Outcomes

Primary Outcome Measures

Cancer Detection

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

Targeting Efficiency (core length, grade)

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

Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)

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

Quality of Life

To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires: IPSS IIEF EQ5D - 5L

Full Information

NCT ID

NCT02341677

First Posted

November 24, 2014

Last Updated

January 29, 2019

Sponsor

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT02341677

Brief Title

SmartTarget: BIOPSY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

November 2014 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms, Diagnostic Techniques and Procedures

Keywords

Prostatic Neoplasms, Diagnostic Techniques and Procedures, Magnetic Resonance Imaging, Ultrasonography, Biopsy, Image Fusion

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biopsy

Arm Type

Experimental

Arm Description

Single Arm Study. Biopsy Intervention.

Intervention Type

Procedure

Intervention Name(s)

SmartTarget - Biopsy

Intervention Description

MRI to ultrasound fusion guided prostate biopsy

Primary Outcome Measure Information:

Title

Cancer Detection

Description

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.

Time Frame

Within 3 weeks of biopsy

Secondary Outcome Measure Information:

Title

Targeting Efficiency (core length, grade)

Description

Time Frame

Within 3 weeks of Biopsy

Title

Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)

Description

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

Time Frame

During Procedure

Title

Quality of Life

Description

To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires: IPSS IIEF EQ5D - 5L

Time Frame

6 Weeks post biopsy

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility 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

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

Facility Information:

Facility Name

University College London

City

London

Country

United Kingdom

12. IPD Sharing Statement

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