Prostate CancerPhase 3FLAMENCT01168479
FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
A Phase 3 study testing FLAME boost and standard arm in people with Prostate Cancer and Radiotherapy, run by UMC Utrecht at 4 sites in 2 countries.
Trial summary
Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy, MRI
- What is being tested?
- FLAME boost and standard arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2009to Jan 2016
- Phase
- Phase 3
- 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
- Prostate cancer patients scheduled for external beam radiotherapy using IMRT and fiducial marker-based position verification
- Intermediate and high risk prostate cancer, defined by Ash et al. 2000, namely:
- One or more factors: T2, or Gleasonscore >7, or iPSA > 10 ng/mL
- WHO score 0-2
Who cannot join
- Low risk prostate cancer, defined by Ash et al. 2000
- World Heath Organisation (WHO) score >2
- International Prostate Symptom Score (IPSS) >20
- If for any patient related reason an MRI cannot be performed
- If anticoagulation cannot be stopped temporarily regarding the implant of fiducial markers
- Previous prostatectomy (except from Trans Urethral Prostatectomy (TURP))
- TURP within 3 months from start treatment
- Previous pelvic irradiation
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
NKI-AvL
Amsterdam, North Holland, 1066CX
Radboud UMC
Nijmegen, Gelderland, 6500HB
University Medical Center Utrecht
Utrecht, 3584CX
About this study
Official title: FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility study up to appr. 85 Gy on the entire prostate has already been performed and showed acceptable toxicity when combined with adequate position verification. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.
Read the detailed description
Objective:
- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
- Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.
Study design: Single blind prospective randomized controlled phase III trial.
Study population: Patients with intermediate or high risk adenocarcinoma of the prostate. Intermediate or high risk is defined according to the Ash et al. 2000 criteria as:
- One (intermediate-risk) or more (high-risk) factors: T2, or Gleasonscore=7, or iPSA 10-20 ng/mL
- One or more (high-risk) factors: T3, or Gleasonscore >7, or iPSA >20 ng/mL
Intervention: The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
Main study endpoint: To decrease the five-year biochemical relapse rate with at least 10%.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will have to fill in a quality of life questionnaire before and after the radiotherapy treatments. The risk associated with the increased dose to the macroscopic tumour is an increase of toxicity and a reduction of quality of life.
- Conditions
- Prostate Cancer, Radiotherapy, MRI
- Being tested
- FLAME boost, standard arm
- Keywords
- prostate cancer, external beam radiotherapy, dose escalation, dose painting, 95Gy in 35 fractions, MRI, FLAME
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLAME boostRadiation
Also called FLAME
In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
standard armRadiation
Also called normal dose
The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week.
| Study group | Role | What they receive |
|---|---|---|
| standard arm | Active comparator | The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. Receives: Radiation: standard arm |
| FLAME boost | Experimental | In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week. Receives: Radiation: FLAME boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.
Measured: Every six months for 10 years
Secondary outcomes (3)
Establish and compare the rates of treatment-related toxicity.
Toxicity is scored by Common Toxicity Criteria (CTC). Every grade>2 is considered severe toxicity.
Measured: Every six months until 10 years
quality of life
Quality of life is measured by: SF-36, EORTC-C30 and EORTC-PR25.
Measured: every six months until 10 year
Disease specific survival
Death with metastases is considered a death caused by the disease.
Measured: every 6 montths until 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 UMC UtrechtThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.G.W. Kerkmeijer, UMC Utrecht
- Investigators
- Linda Kerkmeijer, MD, PhD, Principal investigator, UMC UtrechtUulke van der Heide, PhD, Study director, NKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168479
- Sponsor's protocol ID
- UMCU-FLAME
- Acronym
- FLAME
- Status last verified
- Jun 2020
- First submitted
- 21 Jul 2010
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Menne Guricova K, Groen V, Pos F, Monninkhof E, Elias SG, Haustermans K, Smeenk RJ, van der Voort van Zyp J, Draulans C, Isebaert S, van Houdt PJ, Kerkmeijer LGW, van der Heide UA. Risk Modeling for Individualization of the FLAME Focal Boost Approach in External Beam Radiation Therapy for Patients With Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):66-73. doi: 10.1016/j.ijrobp.2023.07.044. Epub 2023 Sep 18.
PubMed 37725026Kowalchuk RO, Kim H, Harmsen WS, Jeans EB, Morris LK, Mullikin TC, Miller RC, Wong WW, Vargas CE, Trifiletti DM, Phillips RM, Choo CR, Davis BJ, Beriwal S, Tendulkar RD, Stish BJ, Breen WG, Waddle MR. Cost effectiveness of treatment strategies for high risk prostate cancer. Cancer. 2022 Nov 1;128(21):3815-3823. doi: 10.1002/cncr.34450. Epub 2022 Sep 7.
PubMed 36070558Groen VH, Haustermans K, Pos FJ, Draulans C, Isebaert S, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, Kerkmeijer LGW, van der Heide UA. Patterns of Failure Following External Beam Radiotherapy With or Without an Additional Focal Boost in the Randomized Controlled FLAME Trial for Localized Prostate Cancer. Eur Urol. 2022 Sep;82(3):252-257. doi: 10.1016/j.eururo.2021.12.012. Epub 2021 Dec 23.
PubMed 34953603Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, van Vulpen M, Draulans C, van den Bergh L, Isebaert S, van der Heide UA. Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):787-796. doi: 10.1200/JCO.20.02873. Epub 2021 Jan 20.
PubMed 33471548van Schie MA, Janssen TM, Eekhout D, Walraven I, Pos FJ, de Ruiter P, Kotte ANTJ, Monninkhof EM, Kerkmeijer LGW, Draulans C, de Roover R, Haustermans K, Kunze-Busch M, Smeenk RJ, van der Heide UA. Knowledge-Based Assessment of Focal Dose Escalation Treatment Plans in Prostate Cancer. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):1055-1062. doi: 10.1016/j.ijrobp.2020.06.072. Epub 2020 Jul 3.
PubMed 32629078Monninkhof EM, van Loon JWL, van Vulpen M, Kerkmeijer LGW, Pos FJ, Haustermans K, van den Bergh L, Isebaert S, McColl GM, Smeenk RJ, Noteboom J, Walraven I, Peeters PHM, van der Heide UA. Standard whole prostate gland radiotherapy with and without lesion boost in prostate cancer: Toxicity in the FLAME randomized controlled trial. Radiother Oncol. 2018 Apr;127(1):74-80. doi: 10.1016/j.radonc.2017.12.022. Epub 2018 Jan 11.
PubMed 29336835Lips IM, van der Heide UA, Haustermans K, van Lin EN, Pos F, Franken SP, Kotte AN, van Gils CH, van Vulpen M. Single blind randomized phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial. Trials. 2011 Dec 5;12:255. doi: 10.1186/1745-6215-12-255.
PubMed 22141598
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01168479
- Acronym / sponsor ID
- FLAME / UMCU-FLAME
- Conditions
- Prostate Cancer, Radiotherapy, MRI
- Keywords
- prostate cancer, external beam radiotherapy, dose escalation, dose painting, 95Gy in 35 fractions, MRI, FLAME
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jul 2010 (estimated)
- 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.
Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility study up to appr. 85 Gy on the entire prostate has already been performed and showed acceptable toxicity when combined with adequate position verification. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.
Detailed description
Objective:
- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
- Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.
Study design: Single blind prospective randomized controlled phase III trial.
Study population: Patients with intermediate or high risk adenocarcinoma of the prostate. Intermediate or high risk is defined according to the Ash et al. 2000 criteria as:
- One (intermediate-risk) or more (high-risk) factors: T2, or Gleasonscore=7, or iPSA 10-20 ng/mL
- One or more (high-risk) factors: T3, or Gleasonscore >7, or iPSA >20 ng/mL
Intervention: The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
Main study endpoint: To decrease the five-year biochemical relapse rate with at least 10%.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will have to fill in a quality of life questionnaire before and after the radiotherapy treatments. The risk associated with the increased dose to the macroscopic tumour is an increase of toxicity and a reduction of quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard arm | Active comparator | Radiation: standard armThe standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. |
| FLAME boost | Experimental | Radiation: FLAME boostIn the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prostate cancer patients scheduled for external beam radiotherapy using IMRT and fiducial marker-based position verification
- Intermediate and high risk prostate cancer, defined by Ash et al. 2000, namely:
Key exclusion criteria (8 listed)
- Low risk prostate cancer, defined by Ash et al. 2000
- World Heath Organisation (WHO) score >2
- International Prostate Symptom Score (IPSS) >20
- If for any patient related reason an MRI cannot be performed
- If anticoagulation cannot be stopped temporarily regarding the implant of fiducial markers
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 |
|---|---|---|
| FLAME boostAlso: FLAMEIn the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week. | Radiation | FLAME boost |
| standard armAlso: normal doseThe standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. | Radiation | standard arm |
Primary outcome
To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
Time frame: Every six months for 10 years
PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.
3 secondary outcomes
Establish and compare the rates of treatment-related toxicity.
Time frame: Every six months until 10 years
quality of life
Time frame: every six months until 10 year
Disease specific survival
Time frame: every 6 montths until 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Derived from this study: PubMed 37725026Menne Guricova K, Groen V, Pos F, Monninkhof E, Elias SG, Haustermans K, Smeenk RJ, van der Voort van Zyp J, Draulans C, Isebaert S, van Houdt PJ, Kerkmeijer LGW, van der Heide UA. Risk Modeling for Individualization of the FLAME Focal Boost Approach in External Beam Radiation Therapy for Patients With Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):66-73. doi: 10.1016/j.ijrobp.2023.07.044. Epub 2023 Sep 18.
- Derived from this study: PubMed 36070558Kowalchuk RO, Kim H, Harmsen WS, Jeans EB, Morris LK, Mullikin TC, Miller RC, Wong WW, Vargas CE, Trifiletti DM, Phillips RM, Choo CR, Davis BJ, Beriwal S, Tendulkar RD, Stish BJ, Breen WG, Waddle MR. Cost effectiveness of treatment strategies for high risk prostate cancer. Cancer. 2022 Nov 1;128(21):3815-3823. doi: 10.1002/cncr.34450. Epub 2022 Sep 7.
- Derived from this study: PubMed 34953603Groen VH, Haustermans K, Pos FJ, Draulans C, Isebaert S, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, Kerkmeijer LGW, van der Heide UA. Patterns of Failure Following External Beam Radiotherapy With or Without an Additional Focal Boost in the Randomized Controlled FLAME Trial for Localized Prostate Cancer. Eur Urol. 2022 Sep;82(3):252-257. doi: 10.1016/j.eururo.2021.12.012. Epub 2021 Dec 23.
- Derived from this study: PubMed 33471548Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, van Vulpen M, Draulans C, van den Bergh L, Isebaert S, van der Heide UA. Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):787-796. doi: 10.1200/JCO.20.02873. Epub 2021 Jan 20.
- Derived from this study: PubMed 32629078van Schie MA, Janssen TM, Eekhout D, Walraven I, Pos FJ, de Ruiter P, Kotte ANTJ, Monninkhof EM, Kerkmeijer LGW, Draulans C, de Roover R, Haustermans K, Kunze-Busch M, Smeenk RJ, van der Heide UA. Knowledge-Based Assessment of Focal Dose Escalation Treatment Plans in Prostate Cancer. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):1055-1062. doi: 10.1016/j.ijrobp.2020.06.072. Epub 2020 Jul 3.
- Derived from this study: PubMed 29336835Monninkhof EM, van Loon JWL, van Vulpen M, Kerkmeijer LGW, Pos FJ, Haustermans K, van den Bergh L, Isebaert S, McColl GM, Smeenk RJ, Noteboom J, Walraven I, Peeters PHM, van der Heide UA. Standard whole prostate gland radiotherapy with and without lesion boost in prostate cancer: Toxicity in the FLAME randomized controlled trial. Radiother Oncol. 2018 Apr;127(1):74-80. doi: 10.1016/j.radonc.2017.12.022. Epub 2018 Jan 11.
- Derived from this study: PubMed 22141598Lips IM, van der Heide UA, Haustermans K, van Lin EN, Pos F, Franken SP, Kotte AN, van Gils CH, van Vulpen M. Single blind randomized phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial. Trials. 2011 Dec 5;12:255. doi: 10.1186/1745-6215-12-255.
- Click here for more information about this study: FLAME 'Multicenter Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in patients treated with External Beam Radiotherapy for Localized Prostate Cancer'Link provided by the sponsor.
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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.
Linda Kerkmeijer, MD, PhD principal investigator
UMC Utrecht
Uulke van der Heide, PhD study director
NKI
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FLAME boost and standard arm in people with Prostate Cancer and Radiotherapy, run by UMC Utrecht at 4 sites in 2 countries.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care. (time frame: Every six months for 10 years). 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 NCT01168479, which also lists 7 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 2 Jun 2020.