Prostate CancerTRANSLATENCT05179694
The TRANSLATE Trial
A study testing Prostate biopsy in people with Prostate Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,042 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Urology, Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
Roxanne Williams, TRANSLATE@nds.ox.ac.uk
Richard Bryant, MBChB, PhD
About this study
Official title: A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer
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.
Read the detailed description
100,000 men each year in the United Kingdom are referred for investigation for possible prostate cancer based on an abnormal digital rectal examination of the prostate and/or an elevated age-specific PSA blood test. These men may be offered a pre-biopsy MRI scan, followed by a prostate biopsy. Prostate biopsies have typically been taken via an ultrasound-guided transrectal approach (TRUS) under local anaesthetic in the clinic for several decades. However, local anaesthetic transperineal biopsy (LATP) has been pioneered in recent years, in order to sample the prostate gland via the perineum in the clinic, with the potential advantage that the transperineal approach to sampling reduces the risk of serious infection, and improves the sampling of the prostate gland (thus increasing the cancer detection), whilst avoiding the need for general anaesthetic in the operating theatre (as was the case for historical template prostate biopsies).
The way in which urologists take biopsies for possible prostate has started to vary across the United Kingdom; however, no level 1 evidence exists as to which method is best - both in terms of detecting clinically significant prostate cancer, and in terms of the occurrence of serious infection and other common side-effects of the biopsy process, along with patient tolerability, re-biopsy rate, and cost-effectiveness.
The TRANSLATE study aims to recruit 1042 men from at least 9 large Urology departments from United Kingdom Hospitals. These men will be under investigation for possible prostate cancer, and will not have received a prostate biopsy previously.
All men eligible for the study will have had a pre-biopsy MRI scan as part of the investigation for possible prostate cancer. After obtaining informed consent they will be randomised to either a TRUS biopsy or an LATP biopsy. Following the biopsy procedure, the study team will follow up the men in order to determine the rate of detection of clinically significant prostate cancer (primary outcome) in each biopsy group. The study team will also gather information (as secondary outcomes) on the occurrence of any post biopsy infections, and other patient reported biopsy-related complications such as bleeding, bruising, pain, and loss of erections and sexual function. Additionally, the study team will record any subsequent prostate biopsy procedures, which might be recommended if the first prostate biopsy has produced a possible 'false negative' result, where clinicians have concerns that the prostate biopsy result is inconsistent with the pre-biopsy MRI scan result and where there are concerns that a 'clinically significant' prostate cancer may have been under-detected. Data will be collected before the biopsy (baseline), immediately after the biopsy, and then at 7 days, 35 days and 4 months following the biopsy.
The total length of the study is 31 months (to include trial setup phase, recruitment phase, data analysis and write-up of reports and publications). Recruitment of patients will last for 15 months. There will be a formal 'stop/go' review at the end of month 12 (i.e. after a full 6 months of recruitment) in order to ensure that a minimum of 140 patients has been randomised, and that at least 4 centres have been opened to recruitment. If the study team meets the 'stop/go' recruitment target, the trial will continue to recruit for a further 9 months. Data from all patients recruited in the 15 month period will be included in the final analysis.
- Conditions
- Prostate Cancer
- Being tested
- Prostate biopsy
- Keywords
- Biopsy, Transrectal biopsy, Local anaesthetic transperineal biopsy, Pathology, Infection, Tolerability, Complications, Health economics
- Medical subject headings
- Prostatic Neoplasms, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsyDiagnostic test
Prostate biopsy via either the Transrectal route (comparator) or Transperineal route (experimental), each under local anaesthetic.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (8)
Infection
Post-biopsy infection - patient questionnaire reporting.
Measured: 7 days, 35 days, and 4 months post procedure.
Health-related quality of life.
Patient reporting.
Measured: At baseline, 7 days, 35 days and 4 months post procedure.
Patient reported tolerability of the procedure.
ProBE questionnaire.
Measured: Immediately post-procedure.
Patient reported biopsy-related complications.
ProBE questionnaire.
Measured: 7 days post-procedure.
Number of subsequent prostate biopsy procedures required.
Patient reporting.
Measured: 7 days, 35 days, and 4 months post procedure.
Cost-effectiveness.
Resource use questionnaire.
Measured: Baseline, 7 days, 35 days and 4 months post procedure.
Histological parameters (ISUP grade group, cancer core length, core involvement, target biopsy cancer parameters).
Histology reporting of grading of biopsy samples as per local reporting practices.
Measured: Within 4 weeks of biopsy.
Serious adverse events incidence.
Patient questionnaires.
Measured: Up to 4 months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start3 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,042 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Richard Bryant, Principal investigator, University of OxfordAlastair Lamb, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179694
- Sponsor's protocol ID
- 15497-SP001-AC001
- Acronym
- TRANSLATE
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40139210Marian 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.
PubMed 38872174Kaplan-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.
PubMed 37296040
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05179694
- Acronym / sponsor ID
- TRANSLATE / 15497-SP001-AC001
- Conditions
- Prostate Cancer
- Keywords
- Biopsy, Transrectal biopsy, Local anaesthetic transperineal biopsy, Pathology, Infection, Tolerability, Complications, Health economics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,042 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
100,000 men each year in the United Kingdom are referred for investigation for possible prostate cancer based on an abnormal digital rectal examination of the prostate and/or an elevated age-specific PSA blood test. These men may be offered a pre-biopsy MRI scan, followed by a prostate biopsy. Prostate biopsies have typically been taken via an ultrasound-guided transrectal approach (TRUS) under local anaesthetic in the clinic for several decades. However, local anaesthetic transperineal biopsy (LATP) has been pioneered in recent years, in order to sample the prostate gland via the perineum in the clinic, with the potential advantage that the transperineal approach to sampling reduces the risk of serious infection, and improves the sampling of the prostate gland (thus increasing the cancer detection), whilst avoiding the need for general anaesthetic in the operating theatre (as was the case for historical template prostate biopsies).
The way in which urologists take biopsies for possible prostate has started to vary across the United Kingdom; however, no level 1 evidence exists as to which method is best - both in terms of detecting clinically significant prostate cancer, and in terms of the occurrence of serious infection and other common side-effects of the biopsy process, along with patient tolerability, re-biopsy rate, and cost-effectiveness.
The TRANSLATE study aims to recruit 1042 men from at least 9 large Urology departments from United Kingdom Hospitals. These men will be under investigation for possible prostate cancer, and will not have received a prostate biopsy previously.
All men eligible for the study will have had a pre-biopsy MRI scan as part of the investigation for possible prostate cancer. After obtaining informed consent they will be randomised to either a TRUS biopsy or an LATP biopsy. Following the biopsy procedure, the study team will follow up the men in order to determine the rate of detection of clinically significant prostate cancer (primary outcome) in each biopsy group. The study team will also gather information (as secondary outcomes) on the occurrence of any post biopsy infections, and other patient reported biopsy-related complications such as bleeding, bruising, pain, and loss of erections and sexual function. Additionally, the study team will record any subsequent prostate biopsy procedures, which might be recommended if the first prostate biopsy has produced a possible 'false negative' result, where clinicians have concerns that the prostate biopsy result is inconsistent with the pre-biopsy MRI scan result and where there are concerns that a 'clinically significant' prostate cancer may have been under-detected. Data will be collected before the biopsy (baseline), immediately after the biopsy, and then at 7 days, 35 days and 4 months following the biopsy.
The total length of the study is 31 months (to include trial setup phase, recruitment phase, data analysis and write-up of reports and publications). Recruitment of patients will last for 15 months. There will be a formal 'stop/go' review at the end of month 12 (i.e. after a full 6 months of recruitment) in order to ensure that a minimum of 140 patients has been randomised, and that at least 4 centres have been opened to recruitment. If the study team meets the 'stop/go' recruitment target, the trial will continue to recruit for a further 9 months. Data from all patients recruited in the 15 month period will be included in the final analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anaesthetic Transperineal Prostate Biopsy (LATP) | Experimental | Diagnostic Test: Prostate biopsyLATP 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). |
| Transrrectal Ultrasound-guided Prostate Biopsy (TRUS) | Active comparator | Diagnostic Test: Prostate biopsyTRUS 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate biopsyProstate biopsy via either the Transrectal route (comparator) or Transperineal route (experimental), each under local anaesthetic. | Diagnostic test | Local Anaesthetic Transperineal Prostate Biopsy (LATP), Transrrectal Ultrasound-guided Prostate Biopsy (TRUS) |
Primary outcome
Detection of clinically significant prostate cancer.
Time frame: 4 weeks
Clinically significant prostate cancer (as defined by the presence of Gleason Grade Group ≥2 prostate cancer, i.e. any Gleason pattern ≥4 disease).
8 secondary outcomes
Infection
Time frame: 7 days, 35 days, and 4 months post procedure.
Health-related quality of life.
Time frame: At baseline, 7 days, 35 days and 4 months post procedure.
Patient reported tolerability of the procedure.
Time frame: Immediately post-procedure.
Patient reported biopsy-related complications.
Time frame: 7 days post-procedure.
Number of subsequent prostate biopsy procedures required.
Time frame: 7 days, 35 days, and 4 months post procedure.
Cost-effectiveness.
Time frame: Baseline, 7 days, 35 days and 4 months post procedure.
Histological parameters (ISUP grade group, cancer core length, core involvement, target biopsy cancer parameters).
Time frame: Within 4 weeks of biopsy.
Serious adverse events incidence.
Time frame: Up to 4 months post procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 40139210Bryant 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.
- Derived from this study: PubMed 38872174Marian 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.
- Derived from this study: PubMed 37296040Kaplan-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bryant principal investigator
University of Oxford
Alastair Lamb principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate biopsy in people with Prostate Cancer, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roxanne Williams (01865223492, TRANSLATE@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of clinically significant prostate cancer. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179694, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.