The TRANSLATE Trial

NCT05179694 | Unknown DMC

• 1 other identifier: 15497-SP001-AC001
• Study Type: interventional
• Target: 1,042
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Biopsy; Transrectal biopsy; Local anaesthetic transperineal biopsy; Pathology; Infection; Tolerability; Complications; Health economics

Outcome Measures

Primary Outcomes (1)

• Detection of clinically significant prostate cancer.

  Clinically significant prostate cancer (as defined by the presence of Gleason Grade Group ≥2 prostate cancer, i.e. any Gleason pattern ≥4 disease).

  4 weeks

Secondary Outcomes (8)

• Infection

  7 days, 35 days, and 4 months post procedure.

• Health-related quality of life.

  At baseline, 7 days, 35 days and 4 months post procedure.

• Patient reported tolerability of the procedure.

  Immediately post-procedure.

• Patient reported biopsy-related complications.

  7 days post-procedure.

• Number of subsequent prostate biopsy procedures required.

  7 days, 35 days, and 4 months post procedure.

Study Arms (2)

Local Anaesthetic Transperineal Prostate Biopsy (LATP)

EXPERIMENTAL

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).

Diagnostic Test: Prostate biopsy

Transrrectal Ultrasound-guided Prostate Biopsy (TRUS)

ACTIVE COMPARATOR

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).

Diagnostic Test: Prostate biopsy

Interventions

Prostate biopsy DIAGNOSTIC_TEST

Prostate biopsy via either the Transrectal route (comparator) or Transperineal route (experimental), each under local anaesthetic.

Local Anaesthetic Transperineal Prostate Biopsy (LATP); Transrrectal Ultrasound-guided Prostate Biopsy (TRUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Department of Urology, Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

Related Publications (3)

• Bryant 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 DERIVED

• Marian 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 DERIVED

• Kaplan-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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Infections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Richard Bryant

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Alastair Lamb

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanne Williams

CONTACT

01865223492; TRANSLATE@nds.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: January 5, 2022
• Study Start: December 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: October 31, 2023
• Last Updated: January 5, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)