Oligometastatic Prostate CancerPhase 2OMPC-RPMNCT07490210
Rezvilutamide With Radical Prostatectomy and Metastasis-Directed Therapy in Oligometastatic Prostate Cancer
A Phase 2 study testing Metastasis-directed radiotherapy, Rezvilutamide + ADT and Radical prostatectomy in people with Oligometastatic Prostate Cancer, run by Fudan University at 1 site in China.
Trial summary
Prostate cancer represents the second most common malignancy in men worldwide. Oligometastatic prostate cancer (OMPC), defined as a transitional state between localized and widespread metastatic disease (≤10 metastatic lesions without visceral metastases), exhibits relatively indolent biological behavior, offering a… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer
- What is being tested?
- Metastasis-directed radiotherapy, Rezvilutamide + ADT and Radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 May 2032
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation with signed informed consent and understanding of study procedures.
- Age ≥18 years.
- Histologically or cytologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, small cell, sarcomatoid, spindle cell, or signet ring cell histology.
- Metastatic hormone-sensitive prostate cancer (mHSPC) with oligometastatic disease defined as: a) ≤10 metastatic lesions combined (bone lesions on Tc-99m bone scan plus extra-pelvic lymph nodes on CT/MRI); and b) No visceral metastases on CT/MRI.
- Planned or ongoing androgen deprivation therapy (ADT) with LHRH agonist/antagonist (medical castration) or prior bilateral orchiectomy (surgical castration) within ≤4 weeks before enrollment.
- Adequate organ function (without transfusion or hematopoietic growth factor support within 2 weeks prior to screening labs):
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- Absolute neutrophil count (ANC) ≥1.5×10⁹/L
- Platelet count (PLT) ≥100×10⁹/L
- Hemoglobin (Hb) ≥90 g/L
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance >50 mL/min
- Total bilirubin (BIL) ≤1.5×ULN
- AST/SGOT or ALT/SGPT ≤2.5×ULN
- International normalized ratio (INR) ≤1.5, PT and APTT ≤1.5×ULN
- Left ventricular ejection fraction (LVEF) ≥50%
- Male patients with female partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose, and must not donate sperm during this period.
- Ability to comply with the study protocol as judged by the investigator.
- Ability to adhere to scheduled visits, treatment plans, and laboratory assessments.
Who cannot join
- Prior radical prostatectomy, pelvic radiotherapy, prostatic ablation, or any systemic anti-prostate cancer therapy (including novel hormonal therapy, chemotherapy, radionuclide therapy, cancer vaccines, or immune checkpoint inhibitors), except ADT initiated ≤4 weeks prior to randomization that meets inclusion criteria.
- Prior radiotherapy to prostate cancer metastases.
- Known visceral metastases (liver, lung, brain, peritoneum, etc.) or diffuse bone marrow metastases.
- Severe contraindications to surgery or radiotherapy, including major cardiovascular disease (e.g., NYHA Class III-IV heart failure, recent myocardial infarction), pulmonary insufficiency unable to tolerate anesthesia, severe bleeding tendency, or bone marrow suppression.
- Other prior or concurrent malignancies, unless basal cell carcinoma of the skin or other cancers cured for >5 years.
- Active infections, including active hepatitis B (HBV DNA >2×10³ IU/mL), hepatitis C RNA positive with hepatic impairment, HIV infection, or inadequately treated syphilis.
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- Uncontrolled major cardiovascular disease within 6 months prior to screening, including: a) unstable angina or recent myocardial infarction (within 6 months); b) clinically significant arrhythmias (e.g., sustained ventricular tachycardia); c) heart failure (NYHA Class ≥III).
- Severe hepatic or renal dysfunction or other laboratory abnormalities not meeting the organ function requirements specified in Inclusion Criterion #6.
- Known hypersensitivity or history of severe adverse reactions to study medications (novel hormonal agents), anesthetics, or contrast agents used in the study.
- Any medical, psychological, or social factors that may affect patient compliance or interfere with study outcome assessment, including psychiatric disorders, substance abuse, or other conditions deemed unsuitable by the investigator.
- Concurrent participation in another interventional clinical study, or use of any investigational drug or medical device within 4 weeks prior to randomization.
- Any other condition that the investigator considers unsuitable for study participation.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Bo Dai Dai, MD, +86-21 64175590, bodai1978@126.com
About this study
Official title: Rezvilutamide Combined With Radical Prostatectomy and Metastasis-Directed Radiotherapy in Oligometastatic Prostate Cancer Patients: A Multicenter, Three-Arm, Open-Label, Randomized Controlled Phase II Clinical Trial
Prostate cancer represents the second most common malignancy in men worldwide. Oligometastatic prostate cancer (OMPC), defined as a transitional state between localized and widespread metastatic disease (≤10 metastatic lesions without visceral metastases), exhibits relatively indolent biological behavior, offering a window for curative-intent multimodal therapy. While standard systemic therapy with androgen deprivation therapy (ADT) plus novel hormonal agents (NHA) remains the backbone for metastatic hormone-sensitive prostate cancer (mHSPC), emerging evidence suggests that maximal cytoreductive therapy-combining systemic treatment with local interventions (Radical prostatectomy（RP） and Metastasis-directed radiotherapy（MDT）)-may improve survival outcomes. Rezvilutamide (SHR3680), a novel androgen receptor inhibitor independently developed by a Chinese pharmaceutical company, has demonstrated superior radiographic progression-free survival (rPFS) and overall survival (OS) compared to bicalutamide in high-volume mHSPC (CHART study). However, the value of adding metastasis-directed radiotherapy (MDRT) to rezvilutamide and radical prostatectomy in OMPC remains unproven. This trial hypothesizes that maximal cytoreductive therapy (systemic therapy + surgery + MDRT) will significantly prolong progression-free survival (PFS) compared to systemic therapy alone.
This is a multicenter, three-arm, open-label, randomized controlled phase II clinical trial (Protocol No.: MA-PCa-II-023; Lead Investigator: Prof. Bo Dai, Fudan University Shanghai Cancer Center). The study will enroll 300 patients randomized in a 2:2:1 ratio to:
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Arm A (Experimental): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (if PSA decline ≥50%, castrate testosterone level, and resectable disease) → MDT (SBRT 30-40 Gy/3-5 fractions) to all evaluable metastases at month 6 （ 3 month post-surgery）
Arm B (Control): Rezvilutamide (240 mg QD) + ADT alone
Arm C (Factorial): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (without MDT)
Eligible patients are males ≥18 years with histologically confirmed prostate adenocarcinoma (no neuroendocrine differentiation), newly diagnosed mHSPC with oligometastatic disease (≤10 bone/lymph node metastases on conventional imaging; no visceral metastases), and planned ADT. Key exclusion criteria include prior radical prostatectomy, pelvic radiotherapy, systemic therapy for prostate cancer (except ≤4 weeks of ADT), or contraindications to surgery/radiotherapy.
The primary endpoint is PFS, defined as time from randomization to first biochemical progression (PSA rise ≥25% and ≥1 ng/mL above nadir confirmed after ≥3 weeks), radiographic progression (RECIST 1.1/PCWG4), clinical progression (new symptoms from local/metastatic disease), or death. Secondary endpoints include rPFS, OS, PSA response rates (PSA50/PSA90), local therapy completion rate, time to CRPC, quality of life (FACT-P and EPIC-26 questionnaires), and safety profiles. Exploratory endpoints evaluate the role of baseline PSMA PET/CT in staging and the development of artificial intelligence models using multimodal data (clinical, imaging, pathology, molecular) to predict prognosis.
- Conditions
- Oligometastatic Prostate Cancer
- Being tested
- Metastasis-directed radiotherapy, Rezvilutamide + ADT, Radical prostatectomy
- Keywords
- OMPC, MDRT, Rezvilutamide, Radical Prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastasis-directed radiotherapyRadiation
Metastasis-directed radiotherapy (MDRT; SBRT 30-40 Gy/3-5 fractions to all evaluable metastases) at 3 months post-surgery
Rezvilutamide + ADTDrug
Also called Rezvilutamide, ADT
Rezvilutamide (240 mg daily) plus ADT alone until progression or unacceptable toxicity.
Radical prostatectomyProcedure or surgery
Radical prostatectomy with extended pelvic lymph node dissection (ePLND), including removal of the prostate gland, seminal vesicles, and bilateral pelvic lymph node groups (obturator, internal iliac, external iliac, and common iliac nodes), performed in patients with oligometastatic prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Rezvilutamide + RP + MDT | Experimental | Rezvilutamide + ADT +Radical prostatectomy +Metastasis-directed radiotherapy Receives: Radiation: Metastasis-directed radiotherapy; Drug: Rezvilutamide + ADT; Procedure: Radical prostatectomy |
| Rezvilutamide + ADT | Active comparator | Rezvilutamide + ADT Receives: Drug: Rezvilutamide + ADT |
| Rezvilutamide + RP | Experimental | Rezvilutamide+ ADT + Radical prostatectomy Receives: Drug: Rezvilutamide + ADT; Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from randomization to the first occurrence of biochemical progression, radiographic progression, clinical progression, or death.
Biochemical progression: (1) For patients with PSA decline from baseline: PSA increase ≥25% and ≥1 ng/mL above nadir, confirmed by repeat testing ≥3 weeks later; or (2) For patients without PSA decline: PSA increase ≥25% and ≥1 ng/mL above baseline after ≥12 weeks of treatment.
Radiographic progression: Disease progression per RECIST 1.1 (soft tissue) and PCWG4 (bone) criteria.
Clinical progression: New symptoms due to local disease progression, lymph node involvement, or systemic metastases (e.g., pathologic fracture, spinal cord compression, worsening pain unresponsive to symptomatic treatment).
Measured: up to 72 months
Secondary outcomes (7)
Radiographic PFS (rPFS)
Time from randomization to first radiographic disease progression (RECIST 1.1 for soft tissue; PCWG3 for bone) or death.
Measured: up to 72 months
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: up to 72 months
PSA Response Rates
Proportion of patients achieving PSA50 (≥50% decline), PSA90 (≥90% decline), or undetectable PSA (<0.2 ng/mL).
Measured: up to 72 months
Local Therapy Completion Rate
Proportion of patients in experimental arms completing all planned local therapies (surgery ± radiotherapy).
Measured: up to 72 months
Time to CRPC
Time from randomization to castration-resistant prostate cancer (disease progression per PSA or imaging criteria despite castrate testosterone levels <50 ng/dL).
Measured: up to 72 months
3-Year PSA Progression-Free Survival Rate
Proportion of patients without PSA progression at 3 years.
Measured: up to 72 months
Time to PSA Progression
Time from randomization to PSA progression (same criteria as biochemical progression in PFS).
Measured: up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 May 2032 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Bo Dai, Fudan University
- Investigators
- Bo Dai, MD, Principal investigator, Fudan University Shanghai Cancer Cente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490210
- Sponsor's protocol ID
- MA-PCa-II-023
- Acronym
- OMPC-RPM
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rezvilutamide Combined With Radical Prostatectomy and Metastasis-Directed Radiotherapy in Oligometastatic Prostate Cancer Patients: A Multicenter, Three-Arm, Open-Label, Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07490210
- Acronym / sponsor ID
- OMPC-RPM / MA-PCa-II-023
- Conditions
- Oligometastatic Prostate Cancer
- Keywords
- OMPC, MDRT, Rezvilutamide, Radical Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 May 2032 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 24 Mar 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.
Prostate cancer represents the second most common malignancy in men worldwide. Oligometastatic prostate cancer (OMPC), defined as a transitional state between localized and widespread metastatic disease (≤10 metastatic lesions without visceral metastases), exhibits relatively indolent biological behavior, offering a window for curative-intent multimodal therapy. While standard systemic therapy with androgen deprivation therapy (ADT) plus novel hormonal agents (NHA) remains the backbone for metastatic hormone-sensitive prostate cancer (mHSPC), emerging evidence suggests that maximal cytoreductive therapy-combining systemic treatment with local interventions (Radical prostatectomy（RP） and Metastasis-directed radiotherapy（MDT）)-may improve survival outcomes. Rezvilutamide (SHR3680), a novel androgen receptor inhibitor independently developed by a Chinese pharmaceutical company, has demonstrated superior radiographic progression-free survival (rPFS) and overall survival (OS) compared to bicalutamide in high-volume mHSPC (CHART study). However, the value of adding metastasis-directed radiotherapy (MDRT) to rezvilutamide and radical prostatectomy in OMPC remains unproven. This trial hypothesizes that maximal cytoreductive therapy (systemic therapy + surgery + MDRT) will significantly prolong progression-free survival (PFS) compared to systemic therapy alone.
This is a multicenter, three-arm, open-label, randomized controlled phase II clinical trial (Protocol No.: MA-PCa-II-023; Lead Investigator: Prof. Bo Dai, Fudan University Shanghai Cancer Center). The study will enroll 300 patients randomized in a 2:2:1 ratio to:
Arm A (Experimental): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (if PSA decline ≥50%, castrate testosterone level, and resectable disease) → MDT (SBRT 30-40 Gy/3-5 fractions) to all evaluable metastases at month 6 （ 3 month post-surgery）
Arm B (Control): Rezvilutamide (240 mg QD) + ADT alone
Arm C (Factorial): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (without MDT)
Eligible patients are males ≥18 years with histologically confirmed prostate adenocarcinoma (no neuroendocrine differentiation), newly diagnosed mHSPC with oligometastatic disease (≤10 bone/lymph node metastases on conventional imaging; no visceral metastases), and planned ADT. Key exclusion criteria include prior radical prostatectomy, pelvic radiotherapy, systemic therapy for prostate cancer (except ≤4 weeks of ADT), or contraindications to surgery/radiotherapy.
The primary endpoint is PFS, defined as time from randomization to first biochemical progression (PSA rise ≥25% and ≥1 ng/mL above nadir confirmed after ≥3 weeks), radiographic progression (RECIST 1.1/PCWG4), clinical progression (new symptoms from local/metastatic disease), or death. Secondary endpoints include rPFS, OS, PSA response rates (PSA50/PSA90), local therapy completion rate, time to CRPC, quality of life (FACT-P and EPIC-26 questionnaires), and safety profiles. Exploratory endpoints evaluate the role of baseline PSMA PET/CT in staging and the development of artificial intelligence models using multimodal data (clinical, imaging, pathology, molecular) to predict prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rezvilutamide + RP + MDT | Experimental | Radiation: Metastasis-directed radiotherapy, Drug: Rezvilutamide + ADT, Procedure: Radical prostatectomyRezvilutamide + ADT +Radical prostatectomy +Metastasis-directed radiotherapy |
| Rezvilutamide + ADT | Active comparator | Drug: Rezvilutamide + ADTRezvilutamide + ADT |
| Rezvilutamide + RP | Experimental | Drug: Rezvilutamide + ADT, Procedure: Radical prostatectomyRezvilutamide+ ADT + Radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntary participation with signed informed consent and understanding of study procedures.
- Age ≥18 years.
- Histologically or cytologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, small cell, sarcomatoid, spindle cell, or signet ring cell histology.
- Metastatic hormone-sensitive prostate cancer (mHSPC) with oligometastatic disease defined as: a) ≤10 metastatic lesions combined (bone lesions on Tc-99m bone scan plus extra-pelvic lymph nodes on CT/MRI); and b) No visceral metastases on CT/MRI.
- Planned or ongoing androgen deprivation therapy (ADT) with LHRH agonist/antagonist (medical castration) or prior bilateral orchiectomy (surgical castration) within ≤4 weeks before enrollment.
Key exclusion criteria (13 listed)
- Prior radical prostatectomy, pelvic radiotherapy, prostatic ablation, or any systemic anti-prostate cancer therapy (including novel hormonal therapy, chemotherapy, radionuclide therapy, cancer vaccines, or immune checkpoint inhibitors), except ADT initiated ≤4 weeks prior to randomization that meets inclusion criteria.
- Prior radiotherapy to prostate cancer metastases.
- Known visceral metastases (liver, lung, brain, peritoneum, etc.) or diffuse bone marrow metastases.
- Severe contraindications to surgery or radiotherapy, including major cardiovascular disease (e.g., NYHA Class III-IV heart failure, recent myocardial infarction), pulmonary insufficiency unable to tolerate anesthesia, severe bleeding tendency, or bone marrow suppression.
- Other prior or concurrent malignancies, unless basal cell carcinoma of the skin or other cancers cured for >5 years.
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 |
|---|---|---|
| Metastasis-directed radiotherapyMetastasis-directed radiotherapy (MDRT; SBRT 30-40 Gy/3-5 fractions to all evaluable metastases) at 3 months post-surgery | Radiation | Rezvilutamide + RP + MDT |
| Rezvilutamide + ADTAlso: Rezvilutamide, ADTRezvilutamide (240 mg daily) plus ADT alone until progression or unacceptable toxicity. | Drug | Rezvilutamide + ADT, Rezvilutamide + RP, Rezvilutamide + RP + MDT |
| Radical prostatectomyRadical prostatectomy with extended pelvic lymph node dissection (ePLND), including removal of the prostate gland, seminal vesicles, and bilateral pelvic lymph node groups (obturator, internal iliac, external iliac, and common iliac nodes), performed in patients with oligometastatic prostate cancer | Procedure or surgery | Rezvilutamide + RP, Rezvilutamide + RP + MDT |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 72 months
Time from randomization to the first occurrence of biochemical progression, radiographic progression, clinical progression, or death. Biochemical progression: (1) For patients with PSA decline from baseline: PSA increase ≥25% and ≥1 ng/mL above nadir, confirmed by repeat testing ≥3 weeks later; or (2) For patients without PSA decline: PSA increase ≥25% and ≥1 ng/mL above baseline after ≥12 weeks of treatment. Radiographic progression: Disease progression per RECIST 1.1 (soft tissue) and PCWG4 (bone) criteria. Clinical progression: New symptoms due to local disease progression, lymph node involvement, or systemic metastases (e.g., pathologic fracture, spinal cord compression, worsening pain unresponsive to symptomatic treatment).
7 secondary outcomes
Radiographic PFS (rPFS)
Time frame: up to 72 months
Overall Survival (OS)
Time frame: up to 72 months
PSA Response Rates
Time frame: up to 72 months
Local Therapy Completion Rate
Time frame: up to 72 months
Time to CRPC
Time frame: up to 72 months
3-Year PSA Progression-Free Survival Rate
Time frame: up to 72 months
Time to PSA Progression
Time frame: up to 72 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 24 Mar 2026.
- 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.
Bo Dai, MD principal investigator
Fudan University Shanghai Cancer Cente
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 Metastasis-directed radiotherapy, Rezvilutamide + ADT and Radical prostatectomy in people with Oligometastatic Prostate Cancer, run by Fudan University at 1 site 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 17 inclusion and 13 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 24 Mar 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 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. 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 Bo Dai, MD (+86-21 64175590, bodai1978@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 72 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 24 Mar 2026.