SmartTarget: BIOPSY

NCT02341677 | Completed

• 1 other identifier: 14/0044
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Conditions

Prostatic Neoplasms; Diagnostic Techniques and Procedures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 3 weeks of biopsy

Secondary Outcomes (3)

• Targeting Efficiency (core length, grade)

  Within 3 weeks of Biopsy

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

  During Procedure

• Quality of Life

  6 Weeks post biopsy

Study Arms (1)

Biopsy

EXPERIMENTAL

Single Arm Study. Biopsy Intervention.

Procedure: SmartTarget - Biopsy

Interventions

SmartTarget - Biopsy PROCEDURE

MRI to ultrasound fusion guided prostate biopsy

Biopsy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hashim U Ahmed, FRCS PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: January 19, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

GB (1)