Prostate CancerPhase 2NCT02811809
Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer
A Phase 2 study testing Apalutamide and IHT in people with Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study is open to men who have biochemical recurrence (BCR, increased PSA) following local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. 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?
- Apalutamide and IHT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Dec 2025
- Phase
- Phase 2
- 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
- Age ≥ 18 years
- Patients with a diagnosis of adenocarcinoma of the prostate
- Patients with BCR (PSA becomes detectable, with absolute value ≥1) following prostatectomy who have no evidence of metastatic disease based on radiographic assessment.
- Patients with BCR following radiation therapy who have no radiographic involvement per mpMRI and CT (RTOG-ASTRO Phoenix criteria), size of pelvic nodes ≤1 cm, and whose MRI-directed prostate biopsies are negative.
- Patients must be free of serious comorbidity as determined by investigator.
- Clinical laboratory values at screening:
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- Serum testosterone level ≥150 ng/dL
- Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
- Platelet count ≥100,000 /µL independent of transfusion and/or growth factors within 3 months prior to randomization
- Serum albumin ≥3.0 g/dL
- GFR >45 mL/min
- Serum potassium ≥3.5 mmol/L
- Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
- Medications known to lower the seizure threshold (see list under prohibited meds, Appendix 3) must be discontinued or substituted at least 4 weeks prior to study entry.
- Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
- Written, informed consent to participate in this study.
Who cannot join
- PSA doubling time >12 months
- Positive for HIV or chronic hepatitis B or hepatitis C infection
- Another primary malignancy that has not been in remission for at least 2 years. Non-melanoma skin cancer allowed.
- Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of screening laboratory studies.
- Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
- History of any of the following:
Show all 12Show fewer
- Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization Any condition that in the opinion of the investigator, would preclude participation in this study
- Current evidence of any of the following:
- Uncontrolled hypertension
- Gastrointestinal disorder affecting absorption
- Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) Any condition that in the opinion of the investigator, would preclude participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHealth Memorial Hermann Cancer Center
Houston, Texas, 77030
About this study
Official title: Apalutamide Plus Intermittent Hormone Therapy (IHT) Versus IHT Alone in Prostate Cancer Patients With Biochemical Recurrence
This study is open to men who have biochemical recurrence (BCR, increased PSA) following local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low levels of red blood cells that can make people feel tired and weak), diabetes (low blood sugar), heart disease, metabolic syndromes (sometimes called "pre-diabetes" and includes obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood), and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given "breaks" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.
Apalutamide is an investigational drug, which means it has not been approved by the Food and Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life. This study will also look at the safety of Apalutamide and the effects that Apalutamide has on prostate cancer.
Read more
Men will be randomized (like flipping a coin) to receive:
- Group A: Leuprolide + Apalutamide or
- Group B: Leuprolide only (until second leuprolide injection), then leuprolide + Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken by mouth (4 tablets) daily. Each cycle is 4 weeks long.
Intermittent treatment with Apalutamide + leuprolide will continue until continuous leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above undetectable level unless leuprolide is given without pause, every 3 months).
Read the detailed description
Prostate-specific antigen (PSA) is a sensitive and specific biomarker of prostate tissue. Monitoring of PSA after local treatment for prostate cancer can assist in identifying patients who have only increased PSA (biochemical recurrence [BCR]) despite no symptoms, signs, or evidence of radiographic metastatic disease. This subpopulation of patients are referred to as having "biochemical failure." Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia, diabetes, heart disease, metabolic syndromes and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given "breaks" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance, owing to the removal of constant pressure causing faster mutation of resistant cells; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.
Apalutamide is an investigational antitumor drug, taken by mouth. It is a synthetic compound rationally designed to bind the androgen receptor (with higher affinity than enzalutamide or bicalutamide), prevent both nuclear translocation and DNA binding, and induce apoptosis. It has greater antitumor activity at a lower dose, achieves steady-state levels at a lower dose, and accumulates more into tumor tissue without building up in the brain, which both increases effectiveness and decreases the risk of seizure.
Apalutamide's mechanism of action gives it the potential to extend the time to PSA increase during intermittent ADT, delaying the necessity for continuous ADT. Investigators will assess the potential applications of intermittent ADT plus Apalutamide for participants with BCR. This study will elucidate the potential of this regimen to reduce the burden of adverse events of continuous ADT and delay the development of hormone resistance.
This is a randomized crossover study intended to determine the interval of ADT administration achievable with supportive Apalutamide treatment. Investigators will assess the significance of time to PSA recurrence, time to next leuprolide injection, time to testosterone recovery, duration of testosterone recovery, time to biochemical recurrence, percentage of men developing biochemical recurrence, number of detectable CTCs, and quality of life measures.
Treatment will be 66 participants in 2:1 randomized crossover - 45 IHT + apalutamide:21 IHT only until second leuprolide injection, then IHT + apalutamide
Apalutamide + IHT Participants will be treated with 240 mg (4 60 mg tablets) oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.
IHT Participants will receive 22.5 mg 3-month depot intramuscular leuprolide until PSA progression, when they will receive 240 mg oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.
Participants remain on study until continuous ADT is required to maintain castrate PSA levels (i.e., leuprolide is needed every 3 months to maintain PSA <1 ng/dL).
- Conditions
- Prostate Cancer
- Being tested
- Apalutamide, IHT
- Keywords
- Prostate cancer, Apalutamide, IHT, BCR, Biochemical recurrence, intermittent hormone therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Also called ARN-509, JNJ-56021927
Apalutamide 240 mg (4 60mg tablets) daily
IHTDrug
Also called Leuprolide, Lupron Depot
Leuprolide 3-month depot 22.5 intramuscular dose
| Study group | Role | What they receive |
|---|---|---|
| Apalutamide + IHT | Experimental | Participants will be treated with 240 mg (4-60 mg tablets) oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently. Receives: Drug: Apalutamide; Drug: IHT |
| IHT only | Active comparator | Participants will receive 22.5 mg 3-month depot intramuscular leuprolide until PSA progression, then they will crossover to Apalutamide + IHT Receives: Drug: IHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to second injection
Time to second injection
Measured: 48 months
Secondary outcomes (8)
Time to prostate-specific antigen (PSA) nadir
Time to prostate-specific antigen (PSA) nadir
Measured: 48 months
Duration of PSA nadir
Duration of PSA nadir
Measured: 48 months
Time to testosterone recovery to >50 ng/dl
Time to testosterone recovery to >50 ng/dl
Measured: 48 months
Duration of testosterone recovery
Duration of testosterone recovery
Measured: 48 months
Circulating tumor cell (CTC) enumeration
Circulating tumor cell (CTC) enumeration
Measured: 48 months
Time until BCR after discontinuation of Apalutamide and ADT
Time until BCR after discontinuation of Apalutamide and ADT
Measured: 48 months
Quality of life as determined by FACT-P survey
Quality of life as determined by FACT-P survey
Measured: 48 months
Number of Adverse Events
Number of Adverse Events
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startDec 2020 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Withdrawn due to operational issues. The study was withdrawn early, before enrolling its first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Robert J Amato, DO, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811809
- Sponsor's protocol ID
- GU-15-105
- Other IDs
- HSC-MS-16-0477
- Status last verified
- Feb 2020
- First submitted
- 21 Jun 2016
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apalutamide Plus Intermittent Hormone Therapy (IHT) Versus IHT Alone in Prostate Cancer Patients With Biochemical Recurrence
- ClinicalTrials.gov ID
- NCT02811809
- Acronym / sponsor ID
- GU-15-105
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Apalutamide, IHT, BCR, Biochemical recurrence, intermittent hormone therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to operational issues. The study was withdrawn early, before enrolling its first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jun 2016 (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.
This study is open to men who have biochemical recurrence (BCR, increased PSA) following local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low levels of red blood cells that can make people feel tired and weak), diabetes (low blood sugar), heart disease, metabolic syndromes (sometimes called "pre-diabetes" and includes obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood), and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given "breaks" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.
Apalutamide is an investigational drug, which means it has not been approved by the Food and Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life. This study will also look at the safety of Apalutamide and the effects that Apalutamide has on prostate cancer.
Men will be randomized (like flipping a coin) to receive:
- Group A: Leuprolide + Apalutamide or
- Group B: Leuprolide only (until second leuprolide injection), then leuprolide + Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken by mouth (4 tablets) daily. Each cycle is 4 weeks long.
Intermittent treatment with Apalutamide + leuprolide will continue until continuous leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above undetectable level unless leuprolide is given without pause, every 3 months).
Detailed description
Prostate-specific antigen (PSA) is a sensitive and specific biomarker of prostate tissue. Monitoring of PSA after local treatment for prostate cancer can assist in identifying patients who have only increased PSA (biochemical recurrence [BCR]) despite no symptoms, signs, or evidence of radiographic metastatic disease. This subpopulation of patients are referred to as having "biochemical failure." Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia, diabetes, heart disease, metabolic syndromes and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given "breaks" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance, owing to the removal of constant pressure causing faster mutation of resistant cells; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.
Apalutamide is an investigational antitumor drug, taken by mouth. It is a synthetic compound rationally designed to bind the androgen receptor (with higher affinity than enzalutamide or bicalutamide), prevent both nuclear translocation and DNA binding, and induce apoptosis. It has greater antitumor activity at a lower dose, achieves steady-state levels at a lower dose, and accumulates more into tumor tissue without building up in the brain, which both increases effectiveness and decreases the risk of seizure.
Apalutamide's mechanism of action gives it the potential to extend the time to PSA increase during intermittent ADT, delaying the necessity for continuous ADT. Investigators will assess the potential applications of intermittent ADT plus Apalutamide for participants with BCR. This study will elucidate the potential of this regimen to reduce the burden of adverse events of continuous ADT and delay the development of hormone resistance.
This is a randomized crossover study intended to determine the interval of ADT administration achievable with supportive Apalutamide treatment. Investigators will assess the significance of time to PSA recurrence, time to next leuprolide injection, time to testosterone recovery, duration of testosterone recovery, time to biochemical recurrence, percentage of men developing biochemical recurrence, number of detectable CTCs, and quality of life measures.
Treatment will be 66 participants in 2:1 randomized crossover - 45 IHT + apalutamide:21 IHT only until second leuprolide injection, then IHT + apalutamide
Apalutamide + IHT Participants will be treated with 240 mg (4 60 mg tablets) oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.
IHT Participants will receive 22.5 mg 3-month depot intramuscular leuprolide until PSA progression, when they will receive 240 mg oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.
Participants remain on study until continuous ADT is required to maintain castrate PSA levels (i.e., leuprolide is needed every 3 months to maintain PSA <1 ng/dL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apalutamide + IHT | Experimental | Drug: Apalutamide, Drug: IHTParticipants will be treated with 240 mg (4-60 mg tablets) oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently. |
| IHT only | Active comparator | Drug: IHTParticipants will receive 22.5 mg 3-month depot intramuscular leuprolide until PSA progression, then they will crossover to Apalutamide + IHT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Patients with a diagnosis of adenocarcinoma of the prostate
- Patients with BCR (PSA becomes detectable, with absolute value ≥1) following prostatectomy who have no evidence of metastatic disease based on radiographic assessment.
- Patients with BCR following radiation therapy who have no radiographic involvement per mpMRI and CT (RTOG-ASTRO Phoenix criteria), size of pelvic nodes ≤1 cm, and whose MRI-directed prostate biopsies are negative.
- Patients must be free of serious comorbidity as determined by investigator.
Key exclusion criteria (12 listed)
- PSA doubling time >12 months
- Positive for HIV or chronic hepatitis B or hepatitis C infection
- Another primary malignancy that has not been in remission for at least 2 years. Non-melanoma skin cancer allowed.
- Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of screening laboratory studies.
- Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
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 |
|---|---|---|
| ApalutamideAlso: ARN-509, JNJ-56021927Apalutamide 240 mg (4 60mg tablets) daily | Drug | Apalutamide + IHT |
| IHTAlso: Leuprolide, Lupron DepotLeuprolide 3-month depot 22.5 intramuscular dose | Drug | Apalutamide + IHT, IHT only |
Primary outcome
Time to second injection
Time frame: 48 months
Time to second injection
8 secondary outcomes
Time to prostate-specific antigen (PSA) nadir
Time frame: 48 months
Duration of PSA nadir
Time frame: 48 months
Time to testosterone recovery to >50 ng/dl
Time frame: 48 months
Duration of testosterone recovery
Time frame: 48 months
Circulating tumor cell (CTC) enumeration
Time frame: 48 months
Time until BCR after discontinuation of Apalutamide and ADT
Time frame: 48 months
Quality of life as determined by FACT-P survey
Time frame: 48 months
Number of Adverse Events
Time frame: 48 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- 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.
Robert J Amato, DO principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apalutamide and IHT in people with Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site 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 17 inclusion and 12 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: withdrawn, as of the sponsor's last update on 27 Feb 2020. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to second injection (time frame: 48 months). 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 27 Feb 2020.