Prostate CancerPhase 2NCT02649439
Prostvac in Patients With Biochemically Recurrent Prostate Cancer
A Phase 2 study testing PROSTVAC -V and PROSTVAC-F in people with Prostate Cancer, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
Background: Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PROSTVAC -V and PROSTVAC-F
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Dec 2015to 1 Oct 2022
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological documentation of prostate cancer confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, Walter Reed National Military Medical Center, Memorial Sloan Kettering Cancer Center (MSKCC), Dana-Farber Cancer Institute (DFCI) or Beth Israel Deaconess Medical Center (BIDMC) prior to enrollment. If no pathologic specimen is available, patients may enroll with a pathologists report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
- Biochemical progression after definitive radiation or surgery defined as follows:
- For patients following definitive therapy: a rise in prostate-specific antigen (PSA) of greater than or equal to 2ng/mL above the nadir (per Radiation Therapy Oncology Group (RTOG)-American Society for Therapeutic Radiology and Oncology (ASTRO) consensus criteria).
- For patients following radical prostatectomy: rising PSA after surgical procedure. (Patients must have a PSA greater than or equal to 0.8 ng/ml)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 1 (Karnofsky greater than or equal to 80%).
- Patients must have a PSA doubling time of 5-15 months.
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- Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month.
- Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity greater than or equal to grade 2.
- Negative computed tomography (CT) scan/magnetic resonance imaging (MRI) and bone scan for metastatic prostate cancer.
- Hematological eligibility parameters (within 16 days before starting therapy)
- Granulocyte count greater than or equal to 1000/mm^3
- Platelet count greater than or equal to 100 000/mm^3
- Hemoglobin (Hgb) greater than or equal to 10g/dL
- Biochemical eligibility parameters (within 16 days before starting therapy):
- --Hepatic function: bilirubin less than or equal to 1.5mg/dL (OR in patients with Gilbert's syndrome normal.
- No other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses, in the opinion of the investigator
- Willing to travel to the National Institutes of Health (NIH), MSKCC, DFCI, BIDMC for follow-up visits.
- 18 years of age or older.
- Able to understand and sign informed consent.
- Baseline testosterone greater than or equal to 100 ng/dl
- PSA less than or equal to 30 ng/mL.
- The effects PROSTVAC on the developing human fetus are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study therapy and at least one month post therapy. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Who cannot join
- Immunocompromised status due to:
- Human immunodeficiency virus (HIV) positivity.
- Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed.
- Other immunodeficiency diseases
- Splenectomy
- Chronic administration (defined as daily or every other day for continued use > 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, intra-articular injections and topical creams for small body areas is allowed.
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- Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient s ability to carry out the treatment program.
- Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (eg phytoestrogens and saw palmetto)
- History of prior chemotherapy
- History of prior immunotherapy within the last 3 years
- Major surgery within 4 weeks prior to enrollment (Day 1 visit).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to poxviral vaccines (e.g., vaccinia vaccine)
- Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin).
- History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
- Previous serious adverse reactions to smallpox vaccination
- Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: Day 1 vaccination: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with current or extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
- Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs.
- Patients who test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Uncontrolled hypertension (systolic blood pressure (SBP)>170/ DBP>105)
- Recruitment Strategies
- This study will be listed on available websites (www.clinicaltrials.gov,
- https://ccr.cancer.gov/clinical-trials-search-start) and participants will be recruited from the current patient population at NIH.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Background:
Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer.
Read more
Objective:
To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone.
Eligibility:
Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Bone scan
Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body.
Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.
Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months.
During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months.
Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests.
Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.
Read the detailed description
BACKGROUND
- Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (biochemically recurrent prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer and to do so with limited toxicity.
- Prostvac (Prostvac; developed by the National Cancer Institute [NCI] and licensed to BN Immunotherapeutics, Mountain View, CA) is a novel candidate prostate cancer immunotherapy for the treatment of prostate cancer. It is a viral vector based therapeutic cancer vaccine that is administered via subcutaneous injections. In a randomized controlled Phase 2 trial, Prostvac therapy was associated with a prolongation of survival in men with metastatic castrate-resistant prostate cancer. A phase III trial recently completed accrual of patients in this same population.
- There is also rationale to use therapeutic cancer vaccines such as Prostvac in earlier stage prostate cancer patients to maximize the potential therapeutic effect of immune stimulating therapy.
- Analysis of previous trials using therapeutic cancer vaccines alone suggests that such therapies may alter tumor growth rate.
OBJECTIVE
Primary Objective:
-Determine if the therapeutic cancer vaccine prostvac can decrease tumor growth rate as measured by prostate-specific antigen (PSA) rise after 6 months compared to a group getting surveillance alone.
KEY ELIGIBILITY CRITERIA
- Histologically confirmed adenocarcinoma of the prostate
- Patients with negative computed tomography (CT) Scan and Tc-99m Bone Scan
- Patients with a PSA over 0.8 ng/ml for patients following radical prostatectomy or for patients following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir
- Patients with a PSA doubling time of 5-15 months
- No history of active autoimmune disease or history of organ compromising autoimmune disease
- Eastern Cooperative Oncology Group (ECOG) 0 -1
DESIGN
- Randomized study
- Accrual goal is 36 evaluable patients per arm; randomized 1:1 to:
- Arm A: Prostvac for 6 months with an additional optional year of maintenance for eligible patients OR
- Arm B: Surveillance for 6 months, then Prostvac for 6 months with an additional year of maintenance for eligible patients
- Conditions
- Prostate Cancer
- Being tested
- PROSTVAC -V, PROSTVAC-F
- Keywords
- Vaccine, PSA, Surveillance, Immunotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSTVAC -VBiological
Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-FBiological
Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
| Study group | Role | What they receive |
|---|---|---|
| A/PROSTVAC treatment | Experimental | PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients Receives: Biological: PROSTVAC -V; Biological: PROSTVAC-F |
| B/ Delayed PROSTVAC treatment | Experimental | Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients Receives: Biological: PROSTVAC -V; Biological: PROSTVAC-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months
Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Measured: 6 months
Secondary outcomes (2)
Effects of Vaccine on Prostate-specific Antigen (PSA) Growth Rate When PROSTVAC is Initiated After 6 Months on Surveillance
Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Measured: After the participants in the Arm/Group "B/ Delayed PROSTVAC Treatment" received treatment for 6 months after their 6 month surveillance (e.g., 12 months total).
Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months
Normal PSA is 0 nanograms per milliliter (ng/mL). Above 0 ng/mL is considered an increase in tumor growth.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start22 Dec 2015
- Primary completion28 Mar 2019
- Study completion1 Oct 2022
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 National Cancer Institute (NCI)The 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Ravi A. Madan, M.D., National Cancer Institute (NCI)
- Investigators
- Ravi A Madan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649439
- Sponsor's protocol ID
- 160035
- Other IDs
- 16-C-0035
- Status last verified
- Nov 2022
- First submitted
- 6 Jan 2016
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostvac in Patients With Biochemically Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT02649439
- Acronym / sponsor ID
- 160035
- Conditions
- Prostate Cancer
- Keywords
- Vaccine, PSA, Surveillance, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 6 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer.
Objective:
To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone.
Eligibility:
Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Bone scan
Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body.
Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.
Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months.
During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months.
Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests.
Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.
Detailed description
BACKGROUND
- Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (biochemically recurrent prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer and to do so with limited toxicity.
- Prostvac (Prostvac; developed by the National Cancer Institute [NCI] and licensed to BN Immunotherapeutics, Mountain View, CA) is a novel candidate prostate cancer immunotherapy for the treatment of prostate cancer. It is a viral vector based therapeutic cancer vaccine that is administered via subcutaneous injections. In a randomized controlled Phase 2 trial, Prostvac therapy was associated with a prolongation of survival in men with metastatic castrate-resistant prostate cancer. A phase III trial recently completed accrual of patients in this same population.
- There is also rationale to use therapeutic cancer vaccines such as Prostvac in earlier stage prostate cancer patients to maximize the potential therapeutic effect of immune stimulating therapy.
- Analysis of previous trials using therapeutic cancer vaccines alone suggests that such therapies may alter tumor growth rate.
OBJECTIVE
Primary Objective:
-Determine if the therapeutic cancer vaccine prostvac can decrease tumor growth rate as measured by prostate-specific antigen (PSA) rise after 6 months compared to a group getting surveillance alone.
KEY ELIGIBILITY CRITERIA
- Histologically confirmed adenocarcinoma of the prostate
- Patients with negative computed tomography (CT) Scan and Tc-99m Bone Scan
- Patients with a PSA over 0.8 ng/ml for patients following radical prostatectomy or for patients following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir
- Patients with a PSA doubling time of 5-15 months
- No history of active autoimmune disease or history of organ compromising autoimmune disease
- Eastern Cooperative Oncology Group (ECOG) 0 -1
DESIGN
- Randomized study
- Accrual goal is 36 evaluable patients per arm; randomized 1:1 to:
- Arm A: Prostvac for 6 months with an additional optional year of maintenance for eligible patients OR
- Arm B: Surveillance for 6 months, then Prostvac for 6 months with an additional year of maintenance for eligible patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A/PROSTVAC treatment | Experimental | Biological: PROSTVAC -V, Biological: PROSTVAC-FPROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients |
| B/ Delayed PROSTVAC treatment | Experimental | Biological: PROSTVAC -V, Biological: PROSTVAC-FSurveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histopathological documentation of prostate cancer confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, Walter Reed National Military Medical Center, Memorial Sloan Kettering Cancer Center (MSKCC), Dana-Farber Cancer Institute (DFCI) or Beth Israel Deaconess Medical Center (BIDMC) prior to enrollment. If no pathologic specimen is available, patients may enroll with a pathologists report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
- Biochemical progression after definitive radiation or surgery defined as follows:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 1 (Karnofsky greater than or equal to 80%).
- Patients must have a PSA doubling time of 5-15 months.
- Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month.
Key exclusion criteria (22 listed)
- Immunocompromised status due to:
- Chronic administration (defined as daily or every other day for continued use > 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, intra-articular injections and topical creams for small body areas is allowed.
- Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient s ability to carry out the treatment program.
- Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (eg phytoestrogens and saw palmetto)
- History of prior chemotherapy
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 |
|---|---|---|
| PROSTVAC -VRecombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus | Biological | A/PROSTVAC treatment, B/ Delayed PROSTVAC treatment |
| PROSTVAC-FRecombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus | Biological | A/PROSTVAC treatment, B/ Delayed PROSTVAC treatment |
Primary outcome
Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months
Time frame: 6 months
Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
2 secondary outcomes
Effects of Vaccine on Prostate-specific Antigen (PSA) Growth Rate When PROSTVAC is Initiated After 6 Months on Surveillance
Time frame: After the participants in the Arm/Group "B/ Delayed PROSTVAC Treatment" received treatment for 6 months after their 6 month surveillance (e.g., 12 months total).
Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
Ravi A Madan, M.D. principal investigator
National Cancer Institute (NCI)
3 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 PROSTVAC -V and PROSTVAC-F in people with Prostate Cancer, run by National Cancer Institute (NCI) at 3 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 22 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 6 Jul 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?
Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months (time frame: 6 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 14 Nov 2022.