SmartTarget: BIOPSY

• Sponsor: University College, London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02341677
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 6.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms; Diagnostic Techniques and Procedures	Procedure: SmartTarget - Biopsy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 134 participants
• Allocation: N/A
• 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: Nov 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cancer Detection [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) [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) [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 [6 Weeks post biopsy]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College London	London		United Kingdom

Sponsors and Collaborators

• University College, London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT02341677
• Other Study ID Numbers: 14/0044
• First Posted: Jan 19, 2015
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 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

Study Results

No Results Posted as of Jan 31, 2019