Clinical trial NCT02341677: SmartTarget: BIOPSY
Official title: SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Diagnostic Techniques and Procedures
Keywords: Prostatic Neoplasms
Diagnostic Techniques and Procedures
Magnetic Resonance Imaging
Ultrasonography
Biopsy
Image Fusion
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 134
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Cancer Detection
timeFrame: Within 3 weeks of biopsy
Secondary outcomes:
measure: Targeting Efficiency (core length, grade)
timeFrame: Within 3 weeks of Biopsy
measure: Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)
timeFrame: During Procedure
measure: Quality of Life
timeFrame: 6 Weeks post biopsy
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Hashim U Ahmed, FRCS PhD
role: PRINCIPAL_INVESTIGATOR
References: