Malignant Prostate NeoplasmDAPPERNCT05830838
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
A study testing Computed Tomography, Image-Guided Adaptive Radiation Therapy and Magnetic Resonance Imaging in people with Malignant Prostate Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone surgical removal of the prostate (radical prostatectomy). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Malignant Prostate Neoplasm
- What is being tested?
- Computed Tomography, Image-Guided Adaptive Radiation Therapy and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 30 May 2029
- Phase
- Interventional
- 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
- Males age >= 18 years who are receiving post-operative radiation therapy to the prostate fossa, with or without inclusion of the pelvic lymph nodes, for biochemical recurrences after radical prostatectomy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =< 2.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willingness and ability to complete protocol-specified follow-up (during the active monitoring phase of the study).
Who cannot join
- Current evidence of untreated metastatic prostate cancer involving nonregional lymph nodes outside of the bony pelvis, bone, or visceral organs.
- Receipt of cytotoxic chemotherapy within 3 months prior to enrollment.
- Prior radiation therapy to pelvis such that the proposed study treatment volume received 10 Gy or greater.
- Co-morbid severe concurrent disease that would result in a life expectancy of < 5 years.
- Diabetes mellitus-associated vascular ulcers or wounding healing problems, inflammatory bowel disease, or a diagnosed connective tissue disorder.
- Medical or psychiatric conditions that preclude informed decision-making or adherence to study protocols.
- Men of childbearing potential who are unwilling to employ adequate contraception.
- History of a bladder neck contracture, urethral stricture that required dilation, or any surgical repair/reconstruction involving the bladder or urethra other than radical prostatectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Daily Adaptive Post-Prostatectomy Radiation With Stereotactic Ablative Radiotherapy (DAPPER)
This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone surgical removal of the prostate (radical prostatectomy). For patients with prostate cancer who develop a rising prostate specific antigen (PSA) after radical prostatectomy, salvage radiation therapy is the standard of care treatment. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. All patients receiving salvage radiation following radical prostatectomy typically have treatment directed to the prostate fossa, which is the anatomical region around the operative bed that is at highest risk for containing left over tumor. Many patients receiving salvage radiation therapy can also benefit from treatment of the pelvic lymph nodes. Adaptive radiotherapy is an emerging treatment technique that uses daily imaging to adjust treatment volumes, ensure accurate dose delivery, and allow the use of smaller planning target volume margins. Adaptive radiation is ideally suited for the further implementation of SABR treatment regimens directed to the prostate fossa with or without inclusion of the pelvic lymph nodes. While daily adaptive radiation therapy has been reported in other disease settings, there is currently no data about its use for post-prostatectomy radiation. Using daily adaptive radiation techniques may help researchers learn how to minimize exposure to normal tissue and shorten the number of required treatments to better target the radiation dose in prostate cancer patients post-prostatectomy.
Funding provided by Varian Oncology Systems
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate the safety of daily, adaptive online replanning in patients treated with stereotactic body radiation therapy (SBRT) to the prostate +/- pelvic lymph nodes as defined by observation of a grade 3 genitourinary and gastrointestinal toxicity rate of less than or equal to 5%.
SECONDARY OBJECTIVES:
- To determine the feasibility of daily, adaptive online replanning for patients receiving SBRT to the prostate fossa +/- pelvic lymph nodes.
II. To assess the efficacy of daily, adaptive SBRT to the prostate fossa. III. To measure the change in patient reported urinary, bowel, and sexual outcomes following protocol treatment.
EXPLORATORY OBJECTIVE:
- To assess the dosimetric benefits of daily adaptive replanning for prostate fossa/pelvic lymph node SBRT.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo (MRI) of the prostate fossa and pelvis and may undergo positron emission tomography/computed tomography (PET/CT) during screening.
GROUP II: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI of the prostate fossa and pelvis and may undergo PET/CT during screening.
- Conditions
- Malignant Prostate Neoplasm
- Being tested
- Computed Tomography, Image-Guided Adaptive Radiation Therapy, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Image-Guided Adaptive Radiation TherapyRadiation
Also called IGART
Undergo daily adaptive online replanning for SBRT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Group I (daily adaptive online replanning, SBRT) | Experimental | Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo MRI and may undergo PET/CT during screening. Receives: Procedure: Computed Tomography; Radiation: Image-Guided Adaptive Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy |
| Group II (daily adaptive online replanning, SBRT) | Experimental | Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI and may undergo PET/CT during screening. Receives: Procedure: Computed Tomography; Radiation: Image-Guided Adaptive Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe Grade 3 genitourinary and gastrointestinal toxicity rate to demonstrate safety of daily adaptive online replanning
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will report the overall grade 3+ at least possibly related to treatment. The primary safety goal will be officially met if incidence of Grade 3 or greater GU or GU toxicity within 2 years post-RT (grade 3+ at least possibly related to treatment) is 5% or less.
Measured: Up to 2 years post-RT
Secondary outcomes (6)
Evaluate successful completion of daily adaptive radiation planning
Measured by the successful completion of the daily adaptive radiation planning process, allowing the physician to choose this adaptive plan or the preexisting baseline plan. Successful completion of the daily adaptive radiation planning process will be recorded on a per fraction basis for each patient in the Ethos treatment planning system. Will be met if >= 90% of all fractions are completed. Metrics related to treatment times for each fraction, physician choice of baseline versus (vs) adaptive plan, and any potential patient safety issue related to the adaptive planning process will be assessed as well. Will be reported descriptively, including the overall rates and 95% confidence intervals. The continuous variables will be compared between the groups (baseline vs adaptive plans) using the Wilcoxon Rank-Sum test and categorical variables will associated with the groups via chi-square tests. Graphical methods will be used as well, such as boxplots to display the continuous data
Measured: Up to 5 years
Local failure
Local failure will be considered to have occurred if the patient develops a biopsy proven or radiographically confirmed site of recurrent disease within a planning target volume at any time following completion of protocol treatment. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.
Measured: From enrollment up to 5 years
Biochemical failure
Biochemical failure is defined by prostate specific antigen (PSA) measurements following treatment. A biochemical failure will be declared if a patient's PSA rises more than 0.4 ng/ml above their post-radiation therapy nadir. Biochemical failure can also occur if a patient begins a new prostate cancer-directed therapy following radiation therapy prior to reaching the PSA threshold for biochemical failure. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.
Measured: From baseline up to 5 years
Distant metastasis
Distant metastasis is defined as radiographic or histologic confirmed disease progression within non-regional lymph nodes (M1a), bones, or visceral organs. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.
Measured: From baseline up to 5 years
Assess patient reported changes in urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.
EPIC-26 contains 26 item in 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better Health Related Quality of Life. Will calculate the number of patients experiencing a minimally important difference (MID). MID will be considered a chance of >0.5 standard deviations from the pre-treatments median score within a specific domain.
Measured: Up to 2 years
Change in patient reported urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.
EPIC-26 contains 26 item in 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better Health Related Quality of Life. Will measure changes in each domain and report these with 95% confidence intervals over time and associate outcomes with baseline variables.
Measured: Baseline, Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start28 Jul 2023
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley J. Stish, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830838
- Sponsor's protocol ID
- GMROR2251
- Other IDs
- NCI-2023-02453, 22-006248
- Acronym
- DAPPER
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Adaptive Post-Prostatectomy Radiation With Stereotactic Ablative Radiotherapy (DAPPER)
- ClinicalTrials.gov ID
- NCT05830838
- Acronym / sponsor ID
- DAPPER / GMROR2251
- Conditions
- Malignant Prostate Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 26 Apr 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 clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone surgical removal of the prostate (radical prostatectomy). For patients with prostate cancer who develop a rising prostate specific antigen (PSA) after radical prostatectomy, salvage radiation therapy is the standard of care treatment. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. All patients receiving salvage radiation following radical prostatectomy typically have treatment directed to the prostate fossa, which is the anatomical region around the operative bed that is at highest risk for containing left over tumor. Many patients receiving salvage radiation therapy can also benefit from treatment of the pelvic lymph nodes. Adaptive radiotherapy is an emerging treatment technique that uses daily imaging to adjust treatment volumes, ensure accurate dose delivery, and allow the use of smaller planning target volume margins. Adaptive radiation is ideally suited for the further implementation of SABR treatment regimens directed to the prostate fossa with or without inclusion of the pelvic lymph nodes. While daily adaptive radiation therapy has been reported in other disease settings, there is currently no data about its use for post-prostatectomy radiation. Using daily adaptive radiation techniques may help researchers learn how to minimize exposure to normal tissue and shorten the number of required treatments to better target the radiation dose in prostate cancer patients post-prostatectomy.
Funding provided by Varian Oncology Systems
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate the safety of daily, adaptive online replanning in patients treated with stereotactic body radiation therapy (SBRT) to the prostate +/- pelvic lymph nodes as defined by observation of a grade 3 genitourinary and gastrointestinal toxicity rate of less than or equal to 5%.
SECONDARY OBJECTIVES:
- To determine the feasibility of daily, adaptive online replanning for patients receiving SBRT to the prostate fossa +/- pelvic lymph nodes.
II. To assess the efficacy of daily, adaptive SBRT to the prostate fossa. III. To measure the change in patient reported urinary, bowel, and sexual outcomes following protocol treatment.
EXPLORATORY OBJECTIVE:
- To assess the dosimetric benefits of daily adaptive replanning for prostate fossa/pelvic lymph node SBRT.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo (MRI) of the prostate fossa and pelvis and may undergo positron emission tomography/computed tomography (PET/CT) during screening.
GROUP II: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI of the prostate fossa and pelvis and may undergo PET/CT during screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (daily adaptive online replanning, SBRT) | Experimental | Procedure: Computed Tomography, Radiation: Image-Guided Adaptive Radiation Therapy, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Questionnaire Administration, Radiation: Stereotactic Body Radiation TherapyPatients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo MRI and may undergo PET/CT during screening. |
| Group II (daily adaptive online replanning, SBRT) | Experimental | Procedure: Computed Tomography, Radiation: Image-Guided Adaptive Radiation Therapy, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Questionnaire Administration, Radiation: Stereotactic Body Radiation TherapyPatients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI and may undergo PET/CT during screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males age >= 18 years who are receiving post-operative radiation therapy to the prostate fossa, with or without inclusion of the pelvic lymph nodes, for biochemical recurrences after radical prostatectomy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =< 2.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willingness and ability to complete protocol-specified follow-up (during the active monitoring phase of the study).
Key exclusion criteria (8 listed)
- Current evidence of untreated metastatic prostate cancer involving nonregional lymph nodes outside of the bony pelvis, bone, or visceral organs.
- Receipt of cytotoxic chemotherapy within 3 months prior to enrollment.
- Prior radiation therapy to pelvis such that the proposed study treatment volume received 10 Gy or greater.
- Co-morbid severe concurrent disease that would result in a life expectancy of < 5 years.
- Diabetes mellitus-associated vascular ulcers or wounding healing problems, inflammatory bowel disease, or a diagnosed connective tissue disorder.
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT) |
| Image-Guided Adaptive Radiation TherapyAlso: IGARTUndergo daily adaptive online replanning for SBRT | Radiation | Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Group I (daily adaptive online replanning, SBRT), Group II (daily adaptive online replanning, SBRT) |
Primary outcome
Observe Grade 3 genitourinary and gastrointestinal toxicity rate to demonstrate safety of daily adaptive online replanning
Time frame: Up to 2 years post-RT
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will report the overall grade 3+ at least possibly related to treatment. The primary safety goal will be officially met if incidence of Grade 3 or greater GU or GU toxicity within 2 years post-RT (grade 3+ at least possibly related to treatment) is 5% or less.
6 secondary outcomes
Evaluate successful completion of daily adaptive radiation planning
Time frame: Up to 5 years
Local failure
Time frame: From enrollment up to 5 years
Biochemical failure
Time frame: From baseline up to 5 years
Distant metastasis
Time frame: From baseline up to 5 years
Assess patient reported changes in urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.
Time frame: Up to 2 years
Change in patient reported urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.
Time frame: Baseline, Up to 2 years
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 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley J. Stish, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Image-Guided Adaptive Radiation Therapy and Magnetic Resonance Imaging in people with Malignant Prostate Neoplasm, run by Mayo Clinic 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 26 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 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.
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?
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?
Observe Grade 3 genitourinary and gastrointestinal toxicity rate to demonstrate safety of daily adaptive online replanning (time frame: Up to 2 years post-RT). 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 26 Oct 2026.