Castration Levels of TestosteronePhase 2PILLARNCT03503344
Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer
A Phase 2 study testing Apalutamide and Stereotactic Body Radiation Therapy in people with Castration Levels of Testosterone and Castration-Resistant Prostate Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, PSA Progression
- What is being tested?
- Apalutamide and Stereotactic Body Radiation Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2019to 31 Oct 2025
- 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
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Progressive, castration-resistant prostate cancer demonstrated during continuous antiandrogen therapy (ADT), defined as 3 PSA rises at least 1 week apart, with a minimum PSA > .05 ng/mL obtained during screening.
- At least one but no more than 5 discrete PSMA-avid radiation fields on baseline PSMA-PET scan; all PSMA-avid lesions in radiation fields must be amenable to SBRT in judgment of treating radiation oncologist; there are no restrictions on site of lesion/radiation fields (e.g. bone, lymph node, prostate, visceral). Equivocal lesions/radiation fields on PSMA PET scan that are not definitive for metastasis will not count towards the limit of 5 radiation fields and will not undergo SBRT
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL during screening; if the patient is medically castrated, continuous dosing with luteinizing hormone-releasing hormone (LHRH) analogue must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone including post-treatment follow up period
- No prior systemic treatment initiated for the treatment of castration resistant prostate cancer, including abiraterone acetate, enzalutamide, apalutamide, darolutamide, other novel AR or CYP17 antagonist, or docetaxel.
- Patients receiving bone loss prevention treatment with bone-modifying agents (e.g. denosumab, zoledronic acid) must be on stable doses for at least 4 weeks prior to randomization
Show all 22Show fewer
- Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) as most recent treatment must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after washout
- At least 4 weeks or 5 half-lives, whichever is shorter, must have elapsed from the use of any anti-cancer therapy, other than Luteinizing hormone-releasing hormone (LHRH) analog or first generation antiandrogen, prior to randomization
- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
- Resolution of all acute toxic effects of prior therapy or surgical procedure to grade 1 or baseline prior to randomization
- Serum aspartate transaminase (AST) ((serum glutamic oxaloacetic transaminase (SGOT])) and serum alanine transaminase (ALT) (( serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN)
- Total serum bilirubin ≤ 1.5 x ULN; in subjects with known or suspected Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, direct bilirubin is ≤ 1.5 x ULN
- Glomerular filtration rate ≥ 45 ml/min based on Cockcroft-Gault equation
- Absolute neutrophil count (ANC) ≥ 1500/microliter
- Platelets ≥ 75,000/microliter without transfusion and/or growth factors in the 3 months prior to randomization
- Hemoglobin ≥ 9.0 g/dL without transfusion and/or growth factors in the 3 months prior to randomization
- Serum albumin ≥ 3.0 g/dL
- Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to randomization
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures, including ability to swallow study drug tablets and long-term follow-up
- 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
Who cannot join
- Presence of visceral lesions (e.g. lung, liver) detectable on baseline imaging or bone lesions requiring focal radiation treatment at the time of study entry
- History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system (CNS) or meningeal disease which may require treatment with surgery or radiation therapy
- Concurrent therapy with any of the following (all must have been discontinued or substituted for at least 1 week prior to randomization, except for medications known to lower seizure threshold which must be discontinued or substituted at least 4 weeks prior to randomization)
- Medications known to lower the seizure threshold
- Herbal (e.g., saw palmetto) and non-herbal (e.g., pomegranate) products that may decrease PSA levels
- Systemic (oral/intravenous (IV)/intramuscular (IM)) corticosteroids; patients on chronic stable dose of steroids at an equivalent dose of prednisone ≤ 10 mg daily may be permitted to enroll at the discretion of principal investigator
Show all 14Show fewer
- Any other experimental treatment on another clinical trial
- Any of the following within 6 months prior to randomization: Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias
- Uncontrolled hypertension at study entry; patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
- Gastrointestinal disorder affecting absorption
- Secondary malignancy requiring active treatment except for non-melanoma skin cancer and superficial bladder cancer
- Any medical condition that would be a contra-indication to radiation therapy, such as inflammatory bowel disease
- Spinal cord compression or impending spinal cord compression
- Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: A Randomized, Phase II Study of Apalutamide +/- Stereotactic Body Radiotherapy (SBRT) in Castration-Resistant Prostate Cancer Patients With Oligometastatic Disease on PSMA-PET Imaging
This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving apalutamide with or without stereotactic body radiation therapy works better in treating participants with castration-resistant cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate whether the proportion of patients with an undetectable serum prostate specific antigen (PSA) at 6 months following cessation of apalutamide is higher with addition of stereotactic body radiation therapy (SBRT) to prostate specific membrane antigen (PSMA)-avid oligometastatic sites of disease compared to the group of patients receiving apalutamide monotherapy
SECONDARY OBJECTIVES:
- To compare the time to PSA progression by Prostate Cancer Working Group (PCWG) criteria between treatment arms.
II. To evaluate the safety and tolerability of apalutamide in combination with SBRT.
EXPLORATORY OBJECTIVES:
- To characterize the metastatic pattern at baseline and at progression in these patients and to determine whether features of the baseline PSMA-PET scan are associated with treatment outcomes.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
ARM B: Participants receive apalutamide orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions.
After completion of study treatment, participants are followed at for 30 days.
- Conditions
- Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, PSA Progression, Stage IV Prostate Adenocarcinoma AJCC v7
- Being tested
- Apalutamide, Stereotactic Body Radiation Therapy
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
Given PO, 240 mg per day (4 x 60mg tablets)
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm A (apalutamide monotherapy) | Experimental | Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Apalutamide |
| Arm B (apalutamide, SBRT) | Experimental | Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions. Receives: Drug: Apalutamide; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Undetectable Serum Prostate-specific Antigen (PSA)
The primary endpoint for the study is the proportion of participants with undetectable serum PSA (< 0.2 ng/mL) at 6 months following completion of apalutamide therapy (18 months from date of randomization). Participants who discontinue apalutamide prior to completion of 12 months of therapy for reasons other than disease progression by Prostate Cancer Clinical Trials Working Group (PCWG) criteria, as well as participants who withdraw or are lost to follow up, will be considered unevaluable for this analysis. Participants who discontinue treatment for radiographic or clinical progression, even if occurring prior to receipt of Stereotactic radiation therapy (SBRT) in the experimental arm), would be evaluable for analysis of the primary endpoint.
Measured: Approximately 18 months from date of randomization
Secondary outcomes (2)
Median Time to PSA Progression
Time to a diagnosis of PSA progression defined by the Prostate Cancer Working Group (PCWG) criteria will be estimated using Kaplan-Meier methods for each treatment arm and will be used to estimate the median time to progression and 95% confidence interval (CI).
Measured: Up to 36 months
Number of Participants With Treatment-related Adverse Events (AEs)
For each treatment arm, adverse event incidence per group will be summarized by severity (highest grade) for those AEs judged by the Investigator to be probably, possibly, or definitely related to the study treatment and will be summarized by frequency and percentage, with all participants treated in that treatment arm as the denominator unless otherwise specified. In addition, Adverse events with missing severity or relationship to study drug will be classified as severe and treatment-related, respectively.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start17 Dec 2019
- Primary completion31 Dec 2024
- Study completion31 Oct 2025
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 Castration Levels of TestosteroneStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Principal investigator, Rahul Aggarwal, University of California, San Francisco
- Investigators
- Rahul Aggarwal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503344
- Sponsor's protocol ID
- 175519
- Other IDs
- NCI-2018-00572
- Acronym
- PILLAR
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2018
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Study of Apalutamide +/- Stereotactic Body Radiotherapy (SBRT) in Castration-Resistant Prostate Cancer Patients With Oligometastatic Disease on PSMA-PET Imaging
- ClinicalTrials.gov ID
- NCT03503344
- Acronym / sponsor ID
- PILLAR / 175519
- Conditions
- Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, PSA Progression, Stage IV Prostate Adenocarcinoma AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving apalutamide with or without stereotactic body radiation therapy works better in treating participants with castration-resistant cancer.
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate whether the proportion of patients with an undetectable serum prostate specific antigen (PSA) at 6 months following cessation of apalutamide is higher with addition of stereotactic body radiation therapy (SBRT) to prostate specific membrane antigen (PSMA)-avid oligometastatic sites of disease compared to the group of patients receiving apalutamide monotherapy
SECONDARY OBJECTIVES:
- To compare the time to PSA progression by Prostate Cancer Working Group (PCWG) criteria between treatment arms.
II. To evaluate the safety and tolerability of apalutamide in combination with SBRT.
EXPLORATORY OBJECTIVES:
- To characterize the metastatic pattern at baseline and at progression in these patients and to determine whether features of the baseline PSMA-PET scan are associated with treatment outcomes.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
ARM B: Participants receive apalutamide orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions.
After completion of study treatment, participants are followed at for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (apalutamide monotherapy) | Experimental | Drug: ApalutamideParticipants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm B (apalutamide, SBRT) | Experimental | Drug: Apalutamide, Radiation: Stereotactic Body Radiation TherapyParticipants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Progressive, castration-resistant prostate cancer demonstrated during continuous antiandrogen therapy (ADT), defined as 3 PSA rises at least 1 week apart, with a minimum PSA > .05 ng/mL obtained during screening.
- At least one but no more than 5 discrete PSMA-avid radiation fields on baseline PSMA-PET scan; all PSMA-avid lesions in radiation fields must be amenable to SBRT in judgment of treating radiation oncologist; there are no restrictions on site of lesion/radiation fields (e.g. bone, lymph node, prostate, visceral). Equivocal lesions/radiation fields on PSMA PET scan that are not definitive for metastasis will not count towards the limit of 5 radiation fields and will not undergo SBRT
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL during screening; if the patient is medically castrated, continuous dosing with luteinizing hormone-releasing hormone (LHRH) analogue must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone including post-treatment follow up period
- No prior systemic treatment initiated for the treatment of castration resistant prostate cancer, including abiraterone acetate, enzalutamide, apalutamide, darolutamide, other novel AR or CYP17 antagonist, or docetaxel.
Key exclusion criteria (14 listed)
- Presence of visceral lesions (e.g. lung, liver) detectable on baseline imaging or bone lesions requiring focal radiation treatment at the time of study entry
- History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system (CNS) or meningeal disease which may require treatment with surgery or radiation therapy
- Concurrent therapy with any of the following (all must have been discontinued or substituted for at least 1 week prior to randomization, except for medications known to lower seizure threshold which must be discontinued or substituted at least 4 weeks prior to randomization)
- Medications known to lower the seizure threshold
- Herbal (e.g., saw palmetto) and non-herbal (e.g., pomegranate) products that may decrease PSA levels
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 56021927Given PO, 240 mg per day (4 x 60mg tablets) | Drug | Arm A (apalutamide monotherapy), Arm B (apalutamide, SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Arm B (apalutamide, SBRT) |
Primary outcome
Proportion of Participants With Undetectable Serum Prostate-specific Antigen (PSA)
Time frame: Approximately 18 months from date of randomization
The primary endpoint for the study is the proportion of participants with undetectable serum PSA (< 0.2 ng/mL) at 6 months following completion of apalutamide therapy (18 months from date of randomization). Participants who discontinue apalutamide prior to completion of 12 months of therapy for reasons other than disease progression by Prostate Cancer Clinical Trials Working Group (PCWG) criteria, as well as participants who withdraw or are lost to follow up, will be considered unevaluable for this analysis. Participants who discontinue treatment for radiographic or clinical progression, even if occurring prior to receipt of Stereotactic radiation therapy (SBRT) in the experimental arm), would be evaluable for analysis of the primary endpoint.
2 secondary outcomes
Median Time to PSA Progression
Time frame: Up to 36 months
Number of Participants With Treatment-related Adverse Events (AEs)
Time frame: Up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Castration Levels of Testosterone
RecruitingPhase 3
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma
Active, not recruitingPhase 2
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma
Active, not recruitingPhase 2
Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma
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.
Rahul Aggarwal, MD principal investigator
University of California, San Francisco
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 Stereotactic Body Radiation Therapy in people with Castration Levels of Testosterone and Castration-Resistant Prostate Carcinoma, run by University of California, San Francisco 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 22 inclusion and 14 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 21 Jan 2026. 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?
Yes. Results are posted in the registry (first posted 21 Jan 2026). 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?
Proportion of Participants With Undetectable Serum Prostate-specific Antigen (PSA) (time frame: Approximately 18 months from date of randomization). 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 21 Jan 2026.