High Risk Biochemical Recurrence (BCR)Phase 3NCT07875881
A Phase 3 Study of Deutenzalutamide in Patients With High-Risk BCR Prostate Cancer
A Phase 3 study testing Deutenzalutamide Soft Capsules + ADT in people with High Risk Biochemical Recurrence (BCR) and Deutenzalutamide Soft Capsules, run by Hinova Pharmaceuticals Inc. at 3 sites in China.
Trial summary
This is a multicenter, randomized, double- blind, placebo-controlled Phase III trial to evaluate the efficacy and safety of Deutenzalutamide plus ADT versus placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer after definitive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High Risk Biochemical Recurrence (BCR), Deutenzalutamide Soft Capsules
- What is being tested?
- Deutenzalutamide Soft Capsules + ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,044 participants
- Where
- 3 sitesChina
- Study dates
- 31 Oct 2026to 31 Dec 2031
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older men, be willing and able to provide informed consent.
- Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features.
- Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent. Prostate cryoablation is not considered definitive therapy for this study, but its prior use is not exclusionary.
- BCR prostate cancer, PSA doubling time (PSADT)≤9 months as calculated by the sponsor.
- Screening PSA by the local laboratory as described in the protocol for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and for patients who had radiotherapy only as primary treatment for prostate cancer .
- Serum testosterone by the local laboratory ≥150 ng/dL (5.2 nmol/L) at screening.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Estimated life expectancy of ≥12 months.
- Able to swallow the study drug and comply with study requirements.
- Has adequate organ function.
- Must be willing to use reliable contraceptive measures (eg, condom) and refrain from sperm donation throughout the study and through 3 months after the last dose of study drug.
Who cannot join
- Prior or present evidence of distant metastatic disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease. Patients with soft tissue pelvic disease may be eligible if the short axis of the largest lymph node is <20 mm for lymph nodes below aortic bifurcation. If the screening bone scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a second imaging modality (CT, or MRI) does not show bone metastasis. If the imaging results are equivocal or consistent with metastasis by central radiology review, the patient is not eligible for enrollment.
- Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤36 months in duration before randomization, or a single dose or a short course (≤6 months) of hormonal therapy given for rising PSA is allowed.
- Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, darolutamide, apalutamide, rezvilutamide, deutenzalutamide, etc.), CYP17 inhibitors (abiraterone or ketoconazole, etc.), chemotherapy (docetaxel, etc.), immunotherapy (PD-1/PD-L1 inhibitors, etc.), or targeted therapy (PARP inhibitors, AKT inhibitors, etc.).
- Prior or planned bilateral orchiectomy.
- Major surgery within 4 weeks before randomization date.
- Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks before randomization date.
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- For patients who had a prior radical prostatectomy, a suitable candidate for salvage radiotherapy as determined by the investigator in consideration of appropriate guidelines.
- Participation in a clinical study of an investigational agent that inhibits the androgen receptor or androgen synthesis (TAK-700, apalutamide, darolutamide, etc.); however, patients who received placebo are allowed.
- Use of any other investigational agent within 4 weeks before randomization date.
- Known or suspected brain metastasis or active leptomeningeal disease.
- History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote.
- Clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening;
- Unstable angina within 3 months before screening;
- New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure unless a screening echocardiogram or multigated acquisition scan performed within 3 months before the randomization date demonstrates a left ventricular ejection fraction ≥45%;
- History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;
- Screening electrocardiogram (ECG): heart rate ≤50 beats per minute (bradycardia); QTc interval >500 ms;
- Hypotension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure <90 mmHg at screening;
- Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at screening.
- History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma). History of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months before randomization.
- Gastrointestinal disorder affecting drug absorption or swallowing.
- History of allogeneic bone marrow transplantation or organ transplantation requiring continued medical treatment.
- Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis, and other active infections.
- Known hypersensitivity reaction to deutenzalutamide or any of capsule components (polyethylene glycol hydroxystearate, butylated hydroxyanisole, and butylated hydroxytoluene).
- Contraindication to the use of androgen deprivation therapy (ADT).
- In the investigator's opinion, the participant is unsuitable for participation in this study (eg, not consistent with the most beneficial treatment for the participant, participant compliance).
- Ongoing drug or alcohol abuse as per investigator judgment.
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the study, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xu Zhang, Doctor, 86-010-66938008, 18611786984@163.com
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye, Doctor, 86-13701663571, dwyeli@163.com
About this study
Official title: A Phase 3, Randomized, Double Blind, Placebo Controlled Study of Deutenzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With High-Risk Biochemical Recurrence (BCR) of Prostate Cancer
This is a multicenter, randomized, double- blind, placebo-controlled Phase III trial to evaluate the efficacy and safety of Deutenzalutamide plus ADT versus placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer after definitive therapy.
- Being tested
- Deutenzalutamide Soft Capsules + ADT, Placebo + ADT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deutenzalutamide Soft Capsules + ADTDrug
Deutenzalutamide Soft Capsules 80mg(Two capsules)，QD, oral; ADT (Goserelin Acetate Sustained-release Implant) 10.8mg per dose, administered once every 12 weeks
Placebo + ADTDrug
Placebo Two capsules，QD, oral; ADT (Goserelin Acetate Sustained-release Implant) 10.8mg per dose, administered once every 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Deutenzalutamide Soft Capsules+ ADT | Experimental | Deutenzalutamide Soft Capsules + ADT（Goserelin Acetate Sustained-release Implant） Receives: Drug: Deutenzalutamide Soft Capsules + ADT |
| Placebo+ ADT | Placebo comparator | Placebo + ADT（Goserelin Acetate Sustained-release Implant） Receives: Drug: Placebo + ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFS evaluated by BICR
MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first.
Measured: Baseline, Week 25, 49 and every 24 weeks thereafter (± 5 days)
Secondary outcomes (12)
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression was defined as the time in months from randomization to the date of the first PSA value demonstrating progression, while participants were on study treatment, which was subsequently confirmed at least 3 weeks later.
Measured: From randomization until first PSA progression, assessed up to 36 months.
Overall Survival
Overall survival was defined as the time between randomization and death due to any cause.
Measured: From randomization until death due to any cause, assessed up to 60 months.
Time to First Use of New Antineoplastic Therapy
Time to first use of new antineoplastic therapy was defined as the time in months from randomization to first use of new antineoplastic therapy for prostate cancer.
Measured: From randomization until first use of new antineoplastic therapy, assessed up to 36 months.
Time to distant metastasis
The time to distant metastasis was defined as the time in months from randomization to the earliest objective evidence of distant soft tissue metastases or metastatic bone disease by blinded independent central review (BICR).
Measured: From randomization until radiographic progression or death without radiographic progression, whichever occurred first, assessed up to 36 months.
Percentage of participants with undetectable PSA at Week 36 while on study treatment
Undetectable PSA at 36 weeks was serum PSA levels <0.2 ng/mL at Week 36. Percentage of participants with undetectable PSA at Week 36 while on study treatment was calculated as the number of participants with undetectable PSA at Week 36 divided by the number of participants with PSA values at Week 36 and multiplied by 100.
Measured: At Week 36.
Percentage of participants who remain off treatment at 2 years after treatment suspension due to undetectable PSA at Week 36
Percentage of participants who remain off treatment at 2 years after treatment suspension due to undetectable PSA at Week 36 was calculated as the number of participants who remained treatment-free 2 years after suspension of study treatment at Week 36 divided by the number of participants with treatment suspension and multiplied by 100.
Measured: From randomization until 2 years after Week 36, assessed up to 33 months.
7. Percentage of participants with sustained undetectable PSA at 2 years after treatment suspension due to undetectable PSA at Week 36
Percentage of participants with sustained undetectable PSA at 2 years after treatment suspension due to undetectable PSA at Week 36 was calculated as the number of participants with undetectable PSA 2 years after suspension of treatment at Week 36 due to undetectable PSA divided by the number of participants with treatment suspension and multiplied by 100.
Measured: From randomization until 2 years after Week 36, assessed up to 33 months .
Time to reinitiation of endocrine therapy after treatment suspension due to undetectable PSA at Week 36
Time to reinitiation of endocrine therapy after treatment suspension due to undetectable PSA at Week 36 was defined as the time in months between the date of treatment suspension at Week 36 due to undetectable PSA and the date that hormonal therapy was restarted.
Measured: From treatment suspension at Week 36 until resumption of any hormonal therapy, assessed up to 36 months.
Time to castration resistance
Time to castration resistance was defined as the time in months from randomization to the first occurrence of radiographic disease progression by BICR, PSA progression or symptomatic skeletal event (SSE) whichever occurred first with castrate levels of testosterone (<50 ng/dL).
Measured: From randomization to the first occurrence of radiographic disease progression, PSA progression or SSE, whichever occurred first with castrate levels of testosterone, assessed up to 36 months.
Time to symptomatic progression
Time to symptomatic progression was defined as the time in months from randomization to development of a skeletal-related event, worsening of disease-related symptoms requiring initiation of a new antineoplastic therapy, or development of adverse events (AEs) and clinically significant signs and/or symptoms due to loco-regional tumor progression requiring opiate use, surgical intervention or radiation therapy, whichever occurred first.
Measured: From randomization until the first development of events defined as symptomatic progression, assessed up to 36 months.
Time to first symptomatic skeletal event
Time to first symptomatic skeletal event was defined as the time in months from randomization to use of radiation therapy (external beam radiation therapy or radionuclides) or surgery to bone for prostate cancer, findings of clinically apparent pathologic bone fracture or of spinal cord compression, or new use of opiate and/or systemic antineoplastic therapy due to bone pain, whichever occurred first.
Measured: From randomization until the first development of events defined as SSE, assessed up to 36 months.
Time to clinically relevant pain
Time to clinically relevant pain was defined as the time from randomization to onset of pain progression, where clinically relevant pain progression was defined as a 2-point or greater increase from baseline in the BPI-SF question 3 score.
Measured: From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score, assessed 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 posted15 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Biochemical Recurrence (BCR)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,044 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinova Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875881
- Sponsor's protocol ID
- HC-1119-302
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the unpublished information provided by the sponsor to the researchers and any data generated from this trial are confidential and are exclusive to the sponsor. The researchers agree to keep this information confidential and use it only to complete this study. Such information may not be used for any other purpose without the written consent of the sponsor. The trial results will be presented in the form of a clinical trial report (CSR), which includes the data from all participating units. Any data derived from the trial and involving copyright protection belong to the sponsor. The sponsor has the right to publish these materials and information.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double Blind, Placebo Controlled Study of Deutenzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With High-Risk Biochemical Recurrence (BCR) of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07875881
- Acronym / sponsor ID
- HC-1119-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,044 participants (estimated)
- Lead sponsor
- Hinova Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 15 Oct 2026 (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 a multicenter, randomized, double- blind, placebo-controlled Phase III trial to evaluate the efficacy and safety of Deutenzalutamide plus ADT versus placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer after definitive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deutenzalutamide Soft Capsules+ ADT | Experimental | Drug: Deutenzalutamide Soft Capsules + ADTDeutenzalutamide Soft Capsules + ADT（Goserelin Acetate Sustained-release Implant） |
| Placebo+ ADT | Placebo comparator | Drug: Placebo + ADTPlacebo + ADT（Goserelin Acetate Sustained-release Implant） |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older men, be willing and able to provide informed consent.
- Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features.
- Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent. Prostate cryoablation is not considered definitive therapy for this study, but its prior use is not exclusionary.
- BCR prostate cancer, PSA doubling time (PSADT)≤9 months as calculated by the sponsor.
- Screening PSA by the local laboratory as described in the protocol for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and for patients who had radiotherapy only as primary treatment for prostate cancer .
Key exclusion criteria (29 listed)
- Prior or present evidence of distant metastatic disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease. Patients with soft tissue pelvic disease may be eligible if the short axis of the largest lymph node is <20 mm for lymph nodes below aortic bifurcation. If the screening bone scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a second imaging modality (CT, or MRI) does not show bone metastasis. If the imaging results are equivocal or consistent with metastasis by central radiology review, the patient is not eligible for enrollment.
- Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤36 months in duration before randomization, or a single dose or a short course (≤6 months) of hormonal therapy given for rising PSA is allowed.
- Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, darolutamide, apalutamide, rezvilutamide, deutenzalutamide, etc.), CYP17 inhibitors (abiraterone or ketoconazole, etc.), chemotherapy (docetaxel, etc.), immunotherapy (PD-1/PD-L1 inhibitors, etc.), or targeted therapy (PARP inhibitors, AKT inhibitors, etc.).
- Prior or planned bilateral orchiectomy.
- Major surgery within 4 weeks before randomization date.
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 |
|---|---|---|
| Deutenzalutamide Soft Capsules + ADTDeutenzalutamide Soft Capsules 80mg(Two capsules)，QD, oral; ADT (Goserelin Acetate Sustained-release Implant) 10.8mg per dose, administered once every 12 weeks | Drug | Deutenzalutamide Soft Capsules+ ADT |
| Placebo + ADTPlacebo Two capsules，QD, oral; ADT (Goserelin Acetate Sustained-release Implant) 10.8mg per dose, administered once every 12 weeks | Drug | Placebo+ ADT |
Primary outcome
MFS evaluated by BICR
Time frame: Baseline, Week 25, 49 and every 24 weeks thereafter (± 5 days)
MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first.
12 secondary outcomes
Time to Prostate-specific Antigen (PSA) Progression
Time frame: From randomization until first PSA progression, assessed up to 36 months.
Overall Survival
Time frame: From randomization until death due to any cause, assessed up to 60 months.
Time to First Use of New Antineoplastic Therapy
Time frame: From randomization until first use of new antineoplastic therapy, assessed up to 36 months.
Time to distant metastasis
Time frame: From randomization until radiographic progression or death without radiographic progression, whichever occurred first, assessed up to 36 months.
Percentage of participants with undetectable PSA at Week 36 while on study treatment
Time frame: At Week 36.
Percentage of participants who remain off treatment at 2 years after treatment suspension due to undetectable PSA at Week 36
Time frame: From randomization until 2 years after Week 36, assessed up to 33 months.
7. Percentage of participants with sustained undetectable PSA at 2 years after treatment suspension due to undetectable PSA at Week 36
Time frame: From randomization until 2 years after Week 36, assessed up to 33 months .
Time to reinitiation of endocrine therapy after treatment suspension due to undetectable PSA at Week 36
Time frame: From treatment suspension at Week 36 until resumption of any hormonal therapy, assessed up to 36 months.
Time to castration resistance
Time frame: From randomization to the first occurrence of radiographic disease progression, PSA progression or SSE, whichever occurred first with castrate levels of testosterone, assessed up to 36 months.
Time to symptomatic progression
Time frame: From randomization until the first development of events defined as symptomatic progression, assessed up to 36 months.
Time to first symptomatic skeletal event
Time frame: From randomization until the first development of events defined as SSE, assessed up to 36 months.
Time to clinically relevant pain
Time frame: From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score, assessed up to 36 months.
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 15 Oct 2026.
- Individual participant dataSharing planned: No. All the unpublished information provided by the sponsor to the researchers and any data generated from this trial are confidential and are exclusive to the sponsor. The researchers agree to keep this information confidential and use it only to complete this study. Such information may not be used for any other purpose without the written consent of the sponsor. The trial results will be presented in the form of a clinical trial report (CSR), which includes the data from all participating units. Any data derived from the trial and involving copyright protection belong to the sponsor. The sponsor has the right to publish these materials and information.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deutenzalutamide Soft Capsules + ADT in people with High Risk Biochemical Recurrence (BCR) and Deutenzalutamide Soft Capsules, run by Hinova Pharmaceuticals Inc. at 3 sites in China.
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 11 inclusion and 29 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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 China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xinying Zhang (86-18310792351, xyzhang@hinovapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MFS evaluated by BICR (time frame: Baseline, Week 25, 49 and every 24 weeks thereafter (± 5 days)). 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 15 Oct 2026.