Prostate CancerPhase 2NCT01751451
3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
A Phase 2 study testing Abiraterone acetate, Abiraterone acetate plus degarelix and Degarelix in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 16 sites in United States.
Trial summary
In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). 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?
- Abiraterone acetate, Abiraterone acetate plus degarelix and Degarelix
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 16 sitesUnited States
- Study dates
- 18 Dec 2012to 28 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Male aged 18 years and above
- Patients must have undergone local treatment via radical prostatectomy
- Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.
- Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible
- Histologically confirmed prostate cancer (per standards at Institution of participant registration) currently with progressive disease, defined as:
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- Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential AND
- PSADT ≤ 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm) OR
- Rising PSA as defined above AND
- Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes < 2 cm in short axis.
- Patients must have a serum testosterone of 150 ng/dL or greater
- ECOG performance status of ≤ 2 (Appendix A)
- Adequate bone marrow, hepatic, and renal function, as evidenced within 14 days prior to treatment initiation by:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL without need for hematopoietic growth factor or transfusion support within 30 days prior to treatment initiation
- Aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of the normal range (x ULN)
- Alanine aminotransferase (ALT) ≤ 1.5 x ULN
- Total bilirubin ≤ 1.5 x ULN
- Serum creatinine of ≤ 1.5 mg/dl or Calculated creatinine clearance of ≥ 60 mL/min
- Serum albumin ≥ 3.0 g/dL
- Serum potassium ≥ 3.5 mEq/L
- Prothrombin time (PT) ≤ 1.5 x ULN (or international normalized ratio [INR] ≤ 1.3) unless the patient is receiving anticoagulant therapy
- Partial thromboplastin time (PTT) ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy At least 4 weeks and recovery to Grade 0-1 from reversible effects of prior surgery (i.e., incisional pain, wound drainage)
- Able to swallow the study drug whole as a tablet
- Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken
- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate.
Who cannot join
- Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
- More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex) Note: Patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol.
- Prior ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer.
- Known brain metastasis or evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration
- Patients with equivocal uptake on a bone scan that in the clinician's opinion do not definitively constitute metastatic disease are eligible
- Currently active second malignancy
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- Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:
- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Severe hepatic impairment (Child-Pugh Class C)
- History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
- Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
- Uncontrolled diabetes mellitus
- Active psychiatric condition Use of any prohibited concomitant medications (Section 5.5) within 30 days prior to Cycle 1, Day 1
- Pre-existing condition that warrants long-term corticosteroid use in excess of study dose
- Grade > 2 treatment-related toxicity from prior therapy
- Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone or degarelix
- Administration of an investigational therapeutic within 30 days of Cycle 1, Day1
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
University of North Carolina
Chapel Hill, North Carolina, 27514
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Karmanos Cancer Institute, Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27701
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
NorthShore University Health System
Long Island City, New York
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical Center
New York, New York
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, 97239
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, 10591
About this study
Official title: A Phase 2, Randomized, 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone acetate, Abiraterone acetate plus degarelix, Degarelix
- Keywords
- ABIRATERONE ACETATE (CB 7630), DEGARELIX, PREDNISONE, 12-187
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetateDrug
Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
Abiraterone acetate plus degarelixDrug
Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
DegarelixDrug
Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate | Experimental | Group 1
* Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months Receives: Drug: Abiraterone acetate |
| Abiraterone acetate and Degarelix | Experimental | Group 2
Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
* Degarelix subcutaneous depot injection q 1 month x 8 months Receives: Drug: Abiraterone acetate plus degarelix |
| Degarelix | Experimental | Group 3
• Degarelix subcutaneous depot injection q 1 month x 8 months Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
Measured: 18 months
Soft Tissue Complete Response
In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values.
Measured: 1 year
Secondary outcomes (5)
PSA Response Rate
The percentage of patients with a non-castrate level of testosterone (>150 ng/dL) and an undetectable PSA at 8 months from PSA0 will be measured.
Measured: 8 months
Overall Quality of Life
with particular attention to libido, potency, anxiety, depression, hot flashes, and fatigue. Effects of each arm on health-related quality of life will be assessed via PRO Survey (Appendix C) completed on paper by the patient at the following study visits: Up to 30 Days Prior to Randomization, each Day 1 of Treatment Cycle, End of Treatment, and each Post-Treatment Follow-up.Effects of each arm on quality of life,
Measured: 1 year
Non-hematologic Adverse Events
Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations and clinical laboratory tests throughout the conduct of the study.
Measured: 1 year
Testosterone and Luteinizing Hormone (LH) Recovery Rates
Testosterone and LH recovery rates will be measured at 8 months from the start of randomization and at each month of the 10 month follow up period.
Measured: 8 -10 months
Correlative Tissue Analysis
Tissue samples will be utilized for morphologic assessment, percent tumor involvement (if applicable), and immunohistochemistry. The immunohistochemical markers assessed may be AR, PTEN, PSMA, fatty acid synthase (FASN), phospho-AMPK, phospho-ACC, phospho-S6 kinase, phospho-Akt for the assessment of the AMPK, lipid synthesis, mTOR pathways, and immunological markers.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study start18 Dec 2012
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, OHSU Knight Cancer Institute, Rutgers Cancer Institute of New Jersey, Endeavor Health, Duke University, Northwestern University, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, University of North Carolina, Wayne State University, Perlmutter New York University Cancer Center, Weill Medical College of Cornell University, Ferring Pharmaceuticals, GU Research Network, LLC, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Howard I Scher, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751451
- Sponsor's protocol ID
- 12-187
- Status last verified
- Sep 2020
- First submitted
- 14 Dec 2012
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01751451
- Acronym / sponsor ID
- 12-187
- Conditions
- Prostate Cancer
- Keywords
- ABIRATERONE ACETATE (CB 7630), DEGARELIX, PREDNISONE, 12-187
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, OHSU Knight Cancer Institute, Rutgers Cancer Institute of New Jersey, Endeavor Health, Duke University, Northwestern University, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, University of North Carolina, Wayne State University, Perlmutter New York University Cancer Center, Weill Medical College of Cornell University, Ferring Pharmaceuticals, GU Research Network, LLC, University of California, Los Angeles
- Study start
- 18 Dec 2012 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate | Experimental | Drug: Abiraterone acetateGroup 1 * Abiraterone acetate 1000 mg daily x 8 months * Prednisone 5 mg once daily x 8 months |
| Abiraterone acetate and Degarelix | Experimental | Drug: Abiraterone acetate plus degarelixGroup 2 Abiraterone acetate 1000 mg daily x 8 months * Prednisone 5 mg once daily x 8 months * Degarelix subcutaneous depot injection q 1 month x 8 months |
| Degarelix | Experimental | Drug: DegarelixGroup 3 • Degarelix subcutaneous depot injection q 1 month x 8 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Male aged 18 years and above
- Patients must have undergone local treatment via radical prostatectomy
- Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.
- Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible
Key exclusion criteria (22 listed)
- Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
- More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex) Note: Patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol.
- Prior ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer.
- Known brain metastasis or evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration
- Patients with equivocal uptake on a bone scan that in the clinician's opinion do not definitively constitute metastatic disease are eligible
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 |
|---|---|---|
| Abiraterone acetatePatients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food. | Drug | Abiraterone acetate |
| Abiraterone acetate plus degarelixPatients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter. | Drug | Abiraterone acetate and Degarelix |
| DegarelixPatients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. | Drug | Degarelix |
Primary outcome
Progression-free Survival (PFS)
Time frame: 18 months
defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
Soft Tissue Complete Response
Time frame: 1 year
In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values.
5 secondary outcomes
PSA Response Rate
Time frame: 8 months
Overall Quality of Life
Time frame: 1 year
Non-hematologic Adverse Events
Time frame: 1 year
Testosterone and Luteinizing Hormone (LH) Recovery Rates
Time frame: 8 -10 months
Correlative Tissue Analysis
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink 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.
Howard I Scher, MD principal investigator
Memorial Sloan Kettering Cancer Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone acetate, Abiraterone acetate plus degarelix and Degarelix in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 16 sites in United States.
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 27 inclusion and 22 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (PFS) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2021.