Metastatic Castration-resistant Prostate CancerPhase 2NCT06100705
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
A Phase 2 study testing Testosterone Cypionate and Sipuleucel-T in people with Metastatic Castration-resistant Prostate Cancer, run by Yale University at 1 site in United States.
Trial summary
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Testosterone Cypionate and Sipuleucel-T
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to the initiation of study procedures.
- Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.
- Histologically confirmed adenocarcinoma of the prostate.
- Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI).
- Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:
- By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
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- By measurable disease: Progressive disease by RECIST v1.1 criteria
- By non-measurable disease
- Soft tissue disease: The appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
- Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.
- Castration status confirmed by serum testosterone level <50ng/dL
- ECOG Performance Status of 0 or 1.
- Adequate liver function:
- Bilirubin <2.0 x institutional upper limit of normal (UNL)
- AST (SGOT) <2.5 x UNL
- ALT (SGPT) <2.5 x UNL
- Acceptable renal function
- Serum creatinine <2.0 x UNL
- Acceptable hematologic function:
- Absolute neutrophil count (ANC) ≥ 1.0 x10^9 cells /L)
- Platelet counts ≥ 100 x 10^9 / L)
- Hemoglobin ≥9 g/dL
Who cannot join
- PSA >20ng/dL within the 4 weeks prior to signing ICF
- Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.
- Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.
- Prior systemic treatment with androgen/Androgen signaling Inhibitor (ASI, e.,g, abiraterone, enzalutamide, apalutamide, darolutamide, or bicalutamide), PARP inhibitor, or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.
- Prior prednisone >10mg (or its equivalent) within 2 weeks prior to registration.
- Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration.
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- Prior palliative radiotherapy within 2 weeks prior to registration.
- Radiographic evidence of hepatic metastases
- Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed.
- Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids.
- Known active HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. Note: Participants with resolved, historic HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 will be assessed by the PI and deemed eligible if their viral infections are in remission: without detectable viruses and secondary immunodeficiency, and without requiring any treatments that affects immune function. Eligibility will be determined after a discussion with the PI and adequate standard clinical tests are acquired to prove that they are in remission.
- Active infection requiring parenteral antibiotic therapy or causing fever (temperature >100.5 in Fahrenheit scale) within 1 week prior to registration.
- Life expectancy of less than 6 months prior to signing ICF.
- Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
Joseph W Kim, 12037376467, joseph.w.kim@yale.edu
About this study
Official title: A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
Read the detailed description
The primary endpoint is the immune response to PA2024 as measured by ELISPOT by week 26. This immunological endpoint was chosen as the primary based on the data showing the Sipuleucel-T immune parameters correlating with overall survival from the pooled analysis phase III trials of Sipuleucel-T (Sheikh NA et al. Cancer Immunol Immunother 2013). Secondary endpoints include other immune parameters related to the Sipuleucel-T, including (1) APC cumulative activation (CD54 upregulation), (2) APC number and (3) total nucleated cells (TNC) count, which also have correlated with survival outcomes and clinical endpoints, and (4) T cell proliferation response to PA2024 and PAP, (5) ex vivo cytokine profile and (6) humoral response to PA2024 and PAP, clinical endpoints including: (7) PSA50 response rate (PSA50 RR), (8) objective response rate (ORR), (9) radiographic progression-free survival (rPFS), and (10) overall survival (OS), (11) safety and tolerability. We hypothesize that BAT potentiates the anti-tumor immune response and enhances clinical outcomes when given before and concurrently with Sipuleucel-T. Secondarily, we also hypothesize that the clinical activity of BAT will increase with concurrent Sipuleucel-T, as measured by PSA50 response rate and objective response rate compared to historical controls.
Participants will start with testosterone injection every 4 weeks. The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule. The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met.
The participants will be assessed with HPE, and PSA every 4 weeks, and radiographic assessment per PCWG3 every 12 weeks. DEPO-Testosterone (testosterone cypionate) IM injection will continue until disease progression, unacceptable toxicity, or withdrawal of consent to treatment. In the event of suspected/radiographic disease progression, tumor biopsy may be performed as a standard of care to confirm progression.
- Being tested
- Testosterone Cypionate, Sipuleucel-T
- Keywords
- Sipuleucel-T, Bipolar Androgen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone CypionateDrug
Also called DEPO-Testosterone
Testosterone Cypionate is an androgen and anabolic steroid medication which is used mainly in the treatment of low testosterone levels in men.
Sipuleucel-TDrug
Also called Provenge
Sipuleucel-T is the first FDA-approved immunotherapy in treatment of mCRPC. It is a therapeutic cancer vaccine composed of activated autologous dendritic cells loaded with an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor, PAP-GMCSF, also called PA2024. This cellular product is prepared in three steps: (1) leukapheresis to isolate CD54+ dendritic cells, (2) the cells and harvested and cultured with PA2024 ex vivo, and (3) re-infusion of the activated DC into the original patient. The preparation and administration of this autologous cellular product are done every 2 weeks for a total of three infusions and is designed to elicit an immune response to prostatic acid phosphatase.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Cypionate + Sipuleucel-T | Experimental | Participants will start with testosterone injection every 4 weeks. The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule. The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met. Receives: Drug: Testosterone Cypionate; Drug: Sipuleucel-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the immune response to PA2024 with BAT and Sipuleucel-T
As measured by ELISPOT from blood samples in pg/ml
Measured: Through the study completion, average 12 months
Secondary outcomes (13)
To determine antigen presenting cell (APC) cumulative activation
as assessed by flow cytometry staining and defined as the increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on after culture versus before culture cells from the sipuleucel-T product from blood samples in pg/ml
Measured: Through the study completion, average 12 months
To determine APC number
as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml
Measured: Through the study completion, average 12 months
To determine total nucleated cell count
as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml
Measured: Through the study completion, average 12 months
To determine T cell proliferation to PA2024
As measured by ELISPOT from blood samples in pg/ml
Measured: Through the study completion, average 12 months
To determine T cell proliferation to Prostatic Acid Phosphatase (PAP)
As assessed by tritiated thymidine uptake from blood samples
Measured: Through the study completion, average 12 months
To determine ex vivo cytokine profiles with BAT + Sipuleucel-T
As assessed via Luminex assay from blood samples in pg/ml
Measured: Through the study completion, average 12 months
To determine humeral response with BAT + Sipuleucel-T
As assessed by ELISA from blood samples in pg/ml
Measured: Through the study completion, average 12 months
To determine PSA50 response rate to BAT + Sipuleucel-T
As defined by PSA decline > 50% from baseline at any point
Measured: Through the study completion, average 12 months
To determine objective response rate (ORR) to BAT + Sipuleucel-T
As defined by RECIST v1.1 criteria
Measured: Through the study completion, average 12 months
To estimate radiographic progression free survival (rPFS)
Defined as the time interval from registration to the first occurrence of radiographic progression by Tc99 Bone Scan using PCWG3 criteria or radiographic soft tissue progression by RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From the date of registration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 5 years
To estimate overall survival (OS)
Defined as the time interval from registration to death due to any cause
Measured: From the date of registration until the date of death from any cause, assessed up to 5 years
To assess safety and tolerability to BAT+ Sipuleucel-T
As assessed by using CTCAE version 5.0
Measured: Through the study completion, average 12 months
To explore potential blood-based and tissue-based biomarkers of treatments response and resistance
Blood-based biomarkers will be assessed by next-generation sequencing. Tissue-based biomarkers will be assessed by biopsy of metastasis at the time of clinically suspected or radiographic disease progression if deemed safe and recommended by the PI.
Measured: At screening, at End of Treatment (blood-based biomarker only), and at Disease Progression (tissue-based biomarker only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start20 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, single-arm phase II study
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Dendreon
- Responsible party
- Principal investigator, Joseph W Kim, Yale University
- Investigators
- Joseph W Kim, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100705
- Sponsor's protocol ID
- 2000035188
- Status last verified
- Sep 2026
- First submitted
- 20 Oct 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06100705
- Acronym / sponsor ID
- 2000035188
- Keywords
- Sipuleucel-T, Bipolar Androgen Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Dendreon
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Oct 2023 (actual)
- 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 is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
Detailed description
The primary endpoint is the immune response to PA2024 as measured by ELISPOT by week 26. This immunological endpoint was chosen as the primary based on the data showing the Sipuleucel-T immune parameters correlating with overall survival from the pooled analysis phase III trials of Sipuleucel-T (Sheikh NA et al. Cancer Immunol Immunother 2013). Secondary endpoints include other immune parameters related to the Sipuleucel-T, including (1) APC cumulative activation (CD54 upregulation), (2) APC number and (3) total nucleated cells (TNC) count, which also have correlated with survival outcomes and clinical endpoints, and (4) T cell proliferation response to PA2024 and PAP, (5) ex vivo cytokine profile and (6) humoral response to PA2024 and PAP, clinical endpoints including: (7) PSA50 response rate (PSA50 RR), (8) objective response rate (ORR), (9) radiographic progression-free survival (rPFS), and (10) overall survival (OS), (11) safety and tolerability. We hypothesize that BAT potentiates the anti-tumor immune response and enhances clinical outcomes when given before and concurrently with Sipuleucel-T. Secondarily, we also hypothesize that the clinical activity of BAT will increase with concurrent Sipuleucel-T, as measured by PSA50 response rate and objective response rate compared to historical controls.
Participants will start with testosterone injection every 4 weeks. The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule. The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met.
The participants will be assessed with HPE, and PSA every 4 weeks, and radiographic assessment per PCWG3 every 12 weeks. DEPO-Testosterone (testosterone cypionate) IM injection will continue until disease progression, unacceptable toxicity, or withdrawal of consent to treatment. In the event of suspected/radiographic disease progression, tumor biopsy may be performed as a standard of care to confirm progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, single-arm phase II study
| Arm | Type | Receives |
|---|---|---|
| Testosterone Cypionate + Sipuleucel-T | Experimental | Drug: Testosterone Cypionate, Drug: Sipuleucel-TParticipants will start with testosterone injection every 4 weeks. The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule. The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Written informed consent obtained prior to the initiation of study procedures.
- Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.
- Histologically confirmed adenocarcinoma of the prostate.
- Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI).
- Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:
Key exclusion criteria (14 listed)
- PSA >20ng/dL within the 4 weeks prior to signing ICF
- Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.
- Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.
- Prior systemic treatment with androgen/Androgen signaling Inhibitor (ASI, e.,g, abiraterone, enzalutamide, apalutamide, darolutamide, or bicalutamide), PARP inhibitor, or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.
- Prior prednisone >10mg (or its equivalent) within 2 weeks prior to registration.
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 |
|---|---|---|
| Testosterone CypionateAlso: DEPO-TestosteroneTestosterone Cypionate is an androgen and anabolic steroid medication which is used mainly in the treatment of low testosterone levels in men. | Drug | Testosterone Cypionate + Sipuleucel-T |
| Sipuleucel-TAlso: ProvengeSipuleucel-T is the first FDA-approved immunotherapy in treatment of mCRPC. It is a therapeutic cancer vaccine composed of activated autologous dendritic cells loaded with an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor, PAP-GMCSF, also called PA2024. This cellular product is prepared in three steps: (1) leukapheresis to isolate CD54+ dendritic cells, (2) the cells and harvested and cultured with PA2024 ex vivo, and (3) re-infusion of the activated DC into the original patient. The preparation and administration of this autologous cellular product are done every 2 weeks for a total of three infusions and is designed to elicit an immune response to prostatic acid phosphatase. | Drug | Testosterone Cypionate + Sipuleucel-T |
Primary outcome
To determine the immune response to PA2024 with BAT and Sipuleucel-T
Time frame: Through the study completion, average 12 months
As measured by ELISPOT from blood samples in pg/ml
13 secondary outcomes
To determine antigen presenting cell (APC) cumulative activation
Time frame: Through the study completion, average 12 months
To determine APC number
Time frame: Through the study completion, average 12 months
To determine total nucleated cell count
Time frame: Through the study completion, average 12 months
To determine T cell proliferation to PA2024
Time frame: Through the study completion, average 12 months
To determine T cell proliferation to Prostatic Acid Phosphatase (PAP)
Time frame: Through the study completion, average 12 months
To determine ex vivo cytokine profiles with BAT + Sipuleucel-T
Time frame: Through the study completion, average 12 months
To determine humeral response with BAT + Sipuleucel-T
Time frame: Through the study completion, average 12 months
To determine PSA50 response rate to BAT + Sipuleucel-T
Time frame: Through the study completion, average 12 months
To determine objective response rate (ORR) to BAT + Sipuleucel-T
Time frame: Through the study completion, average 12 months
To estimate radiographic progression free survival (rPFS)
Time frame: From the date of registration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 5 years
To estimate overall survival (OS)
Time frame: From the date of registration until the date of death from any cause, assessed up to 5 years
To assess safety and tolerability to BAT+ Sipuleucel-T
Time frame: Through the study completion, average 12 months
To explore potential blood-based and tissue-based biomarkers of treatments response and resistance
Time frame: At screening, at End of Treatment (blood-based biomarker only), and at Disease Progression (tissue-based biomarker only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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.
Joseph W Kim, MD principal investigator
Yale University
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 Testosterone Cypionate and Sipuleucel-T in people with Metastatic Castration-resistant Prostate Cancer, run by Yale University 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: looking for participants now, as of the sponsor's last update on 10 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Yu (626-252-8737, Ashley.Yu@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the immune response to PA2024 with BAT and Sipuleucel-T (time frame: Through the study completion, average 12 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 10 Sep 2026.