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Local anaesthetic transperineal biopsy versus transrectal prostate biopsy in prostate cancer detection (TRANSLATE): a multicentre, randomised, controlled trial - 01/05/25

Doi : 10.1016/S1470-2045(25)00100-7 
Richard J Bryant, PhD a, b, c, *⁎ , Ioana R Marian, MSc d, Roxanne Williams, BSc (Hons) b, c, J Francisco Lopez, MSc a, Claudia Mercader, FEBU a, Mutie Raslan, FRCS (Urol) a, Christopher Berridge, FRCS (Urol) e, Jessica Whitburn, DPhil f, Teresa Campbell, MSc a, Steve Tuck g, Vicki S Barber, PhD d, Jessica Scaife, PhD b, c, Aimi Hewitt, BSc (Hons) b, c, Amy Taylor, MSc (Res) b, c, Alexander Ooms, MSc d, Filipa Landeiro, DPhil h, Matthew Little, PhD h, Jane Wolstenholme, PhD h, Sukanya Ghosh, FRCR i, John M Reynard, DM a, Freddie C Hamdy, ProfMA a, b, c, Matthew P C Liew, MD j, Tom A Leslie, FRCS (Urol) a, b, k, James W F Catto, ProfPhD l, Derek J Rosario, MD l, Altan Omer, MD e, Daniel W Good, PhD m, Robert HR Gray, MBChB f, Sashi Kommu, FRCS (Urol) n, Daniel Chung, FRCR o, Hannah Wells, MBBCh o, Krishna Narahari, FRCS (Urol) o, Ruth E Macpherson, FRCR p, Clare Verrill, ProfFRCPath b, q, r, Ben Eddy, FRCS (Urol) n, Hide Yamamoto, PhD s, Alastair D Lamb, PhD a, b, t, *
for the

TRANSLATE Trial Study Group

Richard J Bryant, Alastair D Lamb, Roxanne Williams, Ioana R Marian, Teresa Campbell, J Francisco Lopez, Claudia Mercader, Mutie Raslan, Ruth E Macpherson, Clare Verrill, Vicki S Barber, Jessica Scaife, Aimi Hewitt, Amy Taylor, Alexander Ooms, Filipa Landeiro, Jane Wolstenholme, Freddie C Hamdy, John M Reynard, Steve Tuck, Silvia Mantovani, Richard Colling, Lisa Browning, Odette Dawkins, Jacob Freda, Nadjat Medeghri, Lucy Davies, Matthew Parkes, James Whiteside, Kelly Rafique, Toni Bassett, Patrick Tan, Mark Sullivan, Jeremy Crew, William Gietzmann, Sarah Howles, Ben Turney, Sarp Keskin, Ibrahim Jour, Simon Brewster, Musaab Yassin, Catherine Hobbs, Aaron Leiblich, Richard Bell, Angus Campbell, Krishna Narahari, Hannah Wells, Daniel Chung, Clare Geere, Colette Clements, Kevin Pearse, Maggie Saunders, Ceri Morris, Hywel Thomas, Sashi Kommu, Ben Eddy, Jenny Hansen, Adrian Simoes, Curtis Phelan, Matthias Koslowski, Ian Morrison, Hide Yamamoto, Sukanya Ghosh, Alastair Henderson, Julia Sunnucks, Alison Richards, Iveta Los, Graham Russell, Ab A Bhat, Biswaranjan Datta, Dler Besarani, Amit Goel, Jenny Pablo, Soni Xavier, Ellen O’Grady, Bethany Jones, Altan Omer, Christopher Berridge, Davina Hewitt, Sian McKee, Subiatu Wurie, Bidisha Sinha, Nicholas Hedley, Tom A Leslie, Reema A Babu, Claire Chama-Hall, Hayley Moss, Jeannette Smith, Angus Molyneux, Khalid Enver, Imoh Ibiok, Sharadchandra Prasad, Robert HR Gray, Jessica Whitburn, Marjorie Castillo, Sonia Dayal, Yalda Alizadeh, Simon Bay, James WF Catto, Derek J Rosario, Amy Cooney, Michael Slater, Irene Sharkey, Susan Morgan, Steven Kennish, Daniel W Good, Katie Power, Rebecca O’Donnell, Sarah Myerscough, Marie O’Donnell, Julian Keanie, Matthew PC Liew, Joanna Borzomatoa, Lee Unsworth

a Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK 
b Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK 
c Surgical Intervention Trials Unit, University of Oxford, Oxford, UK 
d Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK 
e Department of Urology, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Coventry, UK 
f Department of Urology, Buckinghamshire Healthcare NHS Trust, Wycombe Hospital, High Wycombe, UK 
g Oxfordshire Prostate Cancer Support Group, Oxford, UK 
h Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK 
i Department of Radiology, Maidstone and Tunbridge Wells NHS Trust, Maidstone Hospital, Maidstone, UK 
j Department of Urology, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK 
k Department of Urology, Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes Hospital, Milton Keynes, UK 
l Division of Clinical Medicine, University of Sheffield and Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK 
m Department of Urology, NHS Lothian, Western General Hospital, Edinburgh, UK 
n Department of Urology, East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, UK 
o Department of Urology, Cardiff and Vale University Health Board, University Hospital of Wales, Cardiff, UK 
p Department of Radiology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK 
q Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK 
r Oxford NIHR Biomedical Research Centre, Oxford, UK 
s Department of Urology, Maidstone and Tunbridge Wells NHS Trust, Maidstone Hospital, Maidstone, UK 
t Barts Cancer Institute, Queen Mary University of London, London, UK 

* Correspondence to: Prof Richard J Bryant, Nuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 7DQ, UK Nuffield Department of Surgical Sciences University of Oxford Oxford OX3 7DQ UK

Summary

Background

Prostate cancer diagnosis requires biopsy, traditionally performed under local anaesthetic with ultrasound guidance via a transrectal approach (TRUS). Local anaesthetic ultrasound-guided transperineal biopsy (LATP) is gaining popularity in this setting; however, there is uncertainty regarding prostate sampling, infection rates, tolerability, side-effects, and cost-effectiveness. TRANSLATE was a randomised clinical trial that aimed to compare detection of Gleason Grade Group (GGG) 2 or higher prostate cancer, side-effects, tolerability, and patient-reported outcomes, after LATP versus TRUS biopsy.

Methods

In this randomised clinical trial which was done at ten hospitals in the UK, patients aged 18 years or older were eligible if investigated for suspected prostate cancer based on elevated age-specific prostate-specific antigen or abnormal digital rectal examination, and if biopsy-naive having received pre-biopsy MRI on a 1·5 or higher Tesla scanner. Individuals were excluded if they had any previous prostate biopsy, extensive local disease easily detectable by any biopsy (prostate-specific antigen >50 ng/mL or entire gland replaced by tumour on MRI), symptoms of concurrent or recent urinary tract infection, history of immunocompromise, need for enhanced antibiotic prophylaxis, absent rectum, or inability to position in lithotomy. Participants were randomly assigned in a 1:1 ratio to receive LATP or TRUS biopsy, using web-based software with a randomisation sequence using a minimisation algorithm to ensure balanced allocation across biopsy groups for minimisation factors (recruitment site, and location of the MRI lesion). The primary outcome was detection of GGG 2 or higher prostate cancer, analysed in the modified intention-to-treat population (all randomly assigned to treatment who had a biopsy result available). Key secondary endpoints assessing post-biopsy adverse events were infection, bleeding, urinary and sexual function, tolerability, and patient-reported outcomes. This trial is registered with ClinicalTrials.gov (NCT05179694) and at ISRCTN (ISRCTN98159689), and is complete.

Findings

Between Dec 3, 2021, and Sept 26, 2023, 2078 (76%) of 2727 assessed individuals were eligible, and 1126 (41%) of 2727 agreed to participate. 1044 (93%) of the 1126 participants were White British. Participants were allocated to TRUS (n=564) or LATP (n=562) biopsy, and were followed up at time of biopsy, and at 7 days, 35 days, and 4 months post-biopsy. We found GGG 2 or higher prostate cancer in 329 (60%) of 547 participants with biopsy results randomly assigned to LATP compared with 294 (54%) of 540 participants with biopsy results randomly assigned to TRUS biopsy (odds ratio [OR] 1·32 [95% CI 1·03–1·70]; p=0·031). Infection requiring admission to hospital within 35 days post-biopsy occurred in 2 (<1%) of 562 participants in the LATP group compared with 9 (2%) of 564 in the TRUS group. No statistically significant difference was observed in the reporting of overall biopsy-related complications (LATP 454 [81%] of 562 vs TRUS 436 [77%] of 564, OR 1·23 [95% CI 0·93 to 1·65]), urinary retention requiring catheterisation (LATP 35 [6%] of 562 vs TRUS 27 [5%] of 564), urinary symptoms (median International Prostate Symptom Score: LATP 8 [IQR 4–14] vs TRUS 8 [4–13], OR 0·36 [95% CI –0·38 to 1·10]), nor sexual function (median International Index of Erectile Function score: LATP 5 [2–25] vs TRUS 8 [3–24], OR –0·60 [–1·79 to 0·58]) at 4 months after biopsy. Trial participants more commonly reported LATP biopsy to be immediately painful and embarrassing compared with TRUS (LATP 216 [38%] of 562 vs TRUS 153 [27%] of 564; OR 1·84 [95% CI 1·40 to 2·43]). Serious adverse events occurred in 14 (2%) of 562 participants in the LATP group and 25 (4%) of 564 in the TRUS group.

Interpretation

Among biopsy-naive individuals being investigated for possible prostate cancer, biopsy with LATP led to greater detection of GGG 2 or higher disease compared with TRUS. These findings will help to inform patients, clinicians, clinical guidelines, and policy makers regarding the important trade-offs between LATP and TRUS prostate biopsy.

Funding

National Institute for Health and Care Research (NIHR) Health Technology Assessment.

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© 2025  The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Publié par Elsevier Masson SAS. Tous droits réservés.
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