TRANSLATE: Multicentre Trial of Prostate Biopsy Techniques

What is it about?

The TRANSLATE trial is a UK-wide, multicentre, randomised clinical trial comparing local anaesthetic transperineal prostate biopsy (LATP) and transrectal ultrasound-guided (TRUS) prostate biopsy for biopsy-naive men with suspicion of clinically significant prostate cancer (csPCa). The primary objective is to determine whether LATP biopsy improves the detection of csPCa compared to TRUS biopsy. Secondary objectives include comparing infection rates, health-related quality of life, patient-reported procedure tolerability, patient-reported biopsy-related complications, number of subsequent biopsy procedures required, cost-effectiveness, other histological parameters, and the detection of clinically insignificant PCa. The trial began recruitment on 1 December 2021 and transitioned through its internal pilot phase on 1 May 2022. It is now in progress, with a total of 1042 biopsy-naive men needing to be recruited. The study aims to provide robust prospective data on the diagnostic ability of LATP biopsy versus TRUS biopsy in the primary diagnostic setting. Several other ongoing clinical trials are also investigating LATP biopsy and TRUS biopsy, including the ProBE-C trial, the PCORI trial, and a smaller study in Hong Kong. The TRANSLATE study is expected to complete recruitment within 18 months and report mid-2024.

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Why is it important?

This research is important because it aims to provide level-one evidence on the diagnostic accuracy of local anaesthetic transperineal prostate biopsy (LATP) compared to transrectal ultrasound-guided (TRUS) prostate biopsy in biopsy-naive men undergoing biopsy based on suspicion of clinically significant prostate cancer (csPCa). The study will also compare infection rates, health-related quality of life, patient-reported procedure tolerability, patient-reported biopsy-related complications, number of subsequent prostate biopsy procedures required, cost-effectiveness, other histological parameters, and the burden and rate of detection of clinically insignificant PCa. Key Takeaways: 1. The TRANSLATE trial is a UK-wide, multicentre, randomised clinical trial that aims to determine whether LATP biopsy leads to a higher rate of detection of csPCa compared to TRUS prostate biopsy. 2. The study will provide robust prospective data to determine the diagnostic ability of LATP biopsy vs TRUS biopsy in the primary diagnostic setting. 3. The study is powered to detect a 10% difference in detection rate between LATP biopsy and TRUS biopsy.