Clinical trial · Interventional
The TRANSLATE Trial
A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The TRANSLATE randomised controlled trial aims to evaluate local anaesthetic transperineal biopsy (LATP) versus transrectal ultrasound-guided (TRUS) prostate biopsy, in the evaluation of previously biopsy-naive men being investigated for clinically significant prostate cancer (on the basis of an elevated age-specific PSA, or abnormal digital rectal examination, or MRI-visible lesion). Men under investigation for possible prostate cancer and recruited to TRANSLATE will be randomised to receive either an LATP or TRUS prostate biopsy, with the primary outcome measure being detection of clinically significant prostate cancer (defined as any Gleason pattern 4 disease, i.e. any Gleason Grade Group \>=2 disease). Secondary outcome measures include infection, other complications, tolerability, rate of re-biopsy, detection of clinically insignificant prostate cancer, and a full health economics evaluation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Local Anaesthetic Transperineal Prostate Biopsy (LATP)
- description
- LATP prostate biopsy performed with an average of 12 biopsy cores in 6 sectors depending on prostate size, plus typically 4 target cores per MRI lesion, using an ultrasound probe-mounted LATP needle guidance device (e.g. the "Precision-Point" access system, or BK UA1232, or any other which is used in a virtually identical fashion).
- interventionNames
- Diagnostic Test: Prostate biopsy
- type
- ACTIVE_COMPARATOR
- label
- Transrrectal Ultrasound-guided Prostate Biopsy (TRUS)
- description
- TRUS prostate biopsy performed according to each hospital's standard practice, with an average of 12 biopsy cores, in two sectors with additional target pots (typically 4 target cores per MRI lesion).
- interventionNames
- Diagnostic Test: Prostate biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All biopsy-naïve men aged 18 years and over who, during investigation for suspicion of possible prostate cancer, require a prostate biopsy. This includes: * A PSA value above the age-adjusted upper limit of normal, regardless of the MRI result, OR An abnormal pre-biopsy MRI on a 1.5 Tesla or higher MRI scanner, OR An abnormal prostate DRE (regardless of serum PSA or MRI result) * Considered suitable to tolerate an LATP biopsy procedure by the local clinical team * Able to give informed consent * Able to understand written English to enable completion of study validated patient reported outcome measures (questionnaires). Exclusion Criteria: The participant may not enter the study if ANY of the following apply: * Any previous prostate biopsy * Dysuria on the day of biopsy or untreated urinary tract infection (UTI) * Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate) * May need enhanced antibiotic prophylaxis: Indwelling catheter, recurrent UTIs * Previous abdomino-perineal resection (i.e. absent rectum) * Unable to recline adequately in Lloyd-Davis / lithotomy position (e.g. hip surgery, contractures) * Unable to have a pre-biopsy MRI (e.g. pacemaker, eGFR \<50, claustrophobia) * PSA \>50 ng/ml (i.e. locally advanced/metastatic prostate cancer easily detectable by TRUS).
References
Publications (3)
- DERIVEDBryant RJ, Marian IR, Williams R, Lopez JF, Mercader C, Raslan M, Berridge C, Whitburn J, Campbell T, Tuck S, Barber VS, Scaife J, Hewitt A, Taylor A, Ooms A, Landeiro F, Little M, Wolstenholme J, Ghosh S, Reynard JM, Hamdy FC, Liew MPC, Leslie TA, Catto JWF, Rosario DJ, Omer A, Good DW, Gray RH, Kommu S, Chung D, Wells H, Narahari K, Macpherson RE, Verrill C, Eddy B, Yamamoto H, Lamb AD; TRANSLATE Trial Study Group. Local anaesthetic transperineal biopsy versus transrectal prostate biopsy in prostate cancer detection (TRANSLATE): a multicentre, randomised, controlled trial. Lancet Oncol. 2025 May;26(5):583-595. doi: 10.1016/S1470-2045(25)00100-7. Epub 2025 Mar 23. PMID 40139210
- DERIVEDMarian IR, Ooms A, Holmes J, Parkes MJ, Lamb AD, Bryant RJ. Statistical analysis plan for the TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation of potentially clinically significant prostate cancer) multicentre randomised controlled trial. Trials. 2024 Jun 14;25(1):383. doi: 10.1186/s13063-024-08224-4. PMID 38872174
- DERIVEDKaplan-Marans E, Zhang TR, Hu JC. Differing Recommendations on Prostate Biopsy Approach to Minimize Infections: An Examination of the European Association of Urology and American Urological Association Guidelines. Eur Urol. 2023 Nov;84(5):445-446. doi: 10.1016/j.eururo.2023.05.036. Epub 2023 Jun 7. PMID 37296040