Diagnostic accuracy of biopsy techniques for prostate cancer v1
Research type
Research Study
Full title
Comparing the diagnostic accuracy of biopsy techniques for prostate cancer
IRAS ID
203710
Contact name
JH Donaldson
Contact email
Sponsor organisation
University of Stirling
Clinicaltrials.gov Identifier
REC16/WS/0161, West of Scotland REC
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
The normal clinical pathway within NHS Ayrshire and Arran, involves targeting the prostate for biopsy procedures using two biopsy methods: (1) Trans-rectal ultrasound guided biopsy, and (2) Magnetic Resonance (MR) imaging transrectal ultrasound (TRUS)fusion with use of software.
Method 1: Trans-rectal ultrasound-guided biopsy (TRUSGB) essentially consists of random sampling from different areas of the peripheral zone, and may allow pre-treatment disease risk stratification in only about 16% of patients (where the false-negative rate is 47% and the underestimation of the Gleason score in around 1/3rd of patients) (Costa et al 2015).
Method 2: The MRI-TRUS fusion with software assistance (called Artemis) allows MR imaging to identify targets which is sent to the fusion system where the transrectal US data are acquired during biopsy and both are blended together.The primary research aim: How does the diagnostic accuracy of MRI-TRUS fusion using Artemis (index test) compare to that of TRUSGB biopsy (reference standard) for the detection of prostate cancer?
REC name
West of Scotland REC 5
REC reference
16/WS/0161
Date of REC Opinion
23 Aug 2016
REC opinion
Favourable Opinion