Prostate CancerPhase 2PROSTEP-002NCT04655365
Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.
A Phase 2 study testing Enzalutamide capsule in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 4 sites in Canada.
Trial summary
This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesCanada
- Study dates
- 22 Mar 2022to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate per original diagnosis, with undergoing androgen deprivation therapy such as prior bilateral orchiectomy or surgical castration or LHRH-agonists/LHRH-antagonists.
- Suspected recurrence of prostate cancer based on rising PSA under androgen deprivation therapy. Recurrent castration resistant prostate cancer patients are defined by a rising PSA >1 ng/mL under ADT or surgical castration and with testosterone castration levels < 1.7 nM (PCWG3 criteria).
- Negative, equivocal findings or oligometastatic disease (< 5) for prostate cancer on conventional imaging bone scan AND 2) abdomen-pelvis CT/MRI and chest CT or FDG-PET/CT or 18F-NaF PET/CT performed as standard of care workup within 90 days of signing the ICF.
- The subject is candidate for second line androgen axis targeted inhibitors such as enzalutamide and planned to receive it.
- Life expectancy ≥6 months as determined by the investigator
- Able and willing to provide signed informed consent and comply with protocol requirement
Show all 9Show fewer
- PSA doubling time less or equal to 10 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Able to swallow the study drug and comply with study requirements.
Who cannot join
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to study drug injection.
- Receipt of investigational drug therapy for prostate cancer within 60 days of Day 1.
- Known or suspected brain metastasis or active leptomeningeal disease.
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months before enrollment.
- Major surgery within 4 weeks before randomization date.
Show all 17Show fewer
- Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening.
- Total bilirubin ≥ 1.5-times the upper limit of normal or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5-times the upper limit of normal at screening.
- Creatinine > 2 mg/dL (177 μmol/L) at screening.
- Albumin < 3.0 g/dL (30 g/L) at screening.
- Clinically significant cardiovascular disease
- Gastrointestinal disorder affecting absorption.
- Ongoing drug or alcohol abuse as per investigator judgment.
- Subject has received any investigational radioactive agent within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study.
- Contraindication to enzalutamide
- Treatment with specific (5-α reductase inhibitors, estrogens, cyproterone actetate, biologic agents with antitumor activity, systemic glucocorticoids, androgens, ...) within 4 weeks of day 1 and during the study treatment period
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
CHUM
Montreal, Quebec, H2X 0A9
CUSM
Montreal, Quebec, H3H 2R9,
CHU de Québec-Université Laval
Québec, Quebec
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1J 3H5
About this study
Official title: Detection and Monitoring of Metastasis by 18F-DCFPyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer and Negative, Equivocal, or Oligometastatic Disease on Conventional Imaging (PROSTEP-002)
This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging
Read the detailed description
Prostate cancer (PCa) is the most common solid organ cancer in North American men and is initially androgen sensitive. Therefore, castration and/or androgen receptor blockade remains the central palliative treatment once PCa has metastasized or failed to locoregional therapies. Because androgen deprivation therapy is not curative, all patients will eventually progress to the metastatic castration-resistant prostate cancer state. About 5% of prostate cancers will be metastatic by conventional imaging techniques at diagnosis while most patients achieving CRPC state will first be localized and then progress to metastatic state later in the disease course. Therefore, a significant proportion of patients will progress through an intermediary state of disease defined as the non-metastatic CRPC state (M0CRPC). Over the last year and a half, M0CRPC treatment landscape has completely changed with demonstrating the benefits of second-generation antiandrogens (darolutamide, enzalutamide and apalutamide) to prevent progression of M0CRPC patients. Enzalutamide have then been approved by the Federal Drug Administration and Health Canada for the treatment of M0CRPC.
On the other hand, conventional imaging techniques based on bone turnover (bone scan (BS)) or anatomical features (magnetic resonance imaging (MRI) or computed tomography (CT)) have important limitations and poor accuracy. Bone scans (BS) is the commonest imaging technique used to detect bone metastases in the clinics. BS does not image directly cancer cells, but the effect of cancer on the bone. Other pathologies such as fractures, degenerative arthritis and other benign bone lesions can also cause focal uptake on BS and lead to false-positive results. Another drawback of BS is its poor sensitivity to image small metastases confined to bone marrow. These limitations stress the importance to improve PCa imaging by using new imaging modalities.
Because novel agents targeting the androgen synthesis and receptor axis (e.g. enzalutamide), bone metastasis (radium-223) and microtubules assembly (docetaxel, cabazitaxel) have been shown to increase metastatic CRPC patients overall survival, a burning question is to determine if the non-metastatic CRPC status is real. There is growing evidence that newer imaging techniques using positron emission tomography can improve metastasis detection accuracy and may refine PCa patient prognostic stratification and treatment eligibility.
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide capsule
- Keywords
- Untreated Castration Resistant Prostate Cancer, 18F-DCFPyL, Enzalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide capsuleDrug
Also called Xantdi
160 mg po id
| Study group | Role | What they receive |
|---|---|---|
| Resistant Prostate Cancer and Negative, Equivocal or Oligometastatic Disease on Conventional Imaging | Experimental | Enrolled subjects will receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL Injection followed by a single PET/CT scan acquired at 1-2 hours post-dosing. After initial 18F-DCFPyL PET/CT, the patients with positive 18F-DCFPyL PET/CT imaging will be treated with enzalutamide (160 mg po id) for M0CRPC disease within less than two weeks. 18F-DCFPyL PET/CT scan will then be repeated 90 days after the start of enzalutamide treatment.
A final follow-up imaging (18F-DCFPyL PET/CT) at progression or at the final follow-up imaging examination at 18 months after the new complete ICF or in September 2026 (whichever comes first) will be performed. Receives: Drug: Enzalutamide capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of patients presenting new metastatic lesions detected by 18F-DCFPyL-PSMA PET/CT in castration resistant prostate cancer patients presenting non metastatic, equivocal or oligometastatic (< 5 metastasis) disease
Number of patients presenting with metastases per compartment (bone, visceral, lymph node) determined by 18F-DCFPyL-PSMA PET/CT that were negative or equivocal on conventional imaging. determined by 18F-DCFPyL-PET/CT.
Measured: Through study completion, an average of 1 year
Determine the number of discordant lesions between conventional and PSMA-PET/CT imaging in castration resistant prostate cancer patients presenting with non metastatic, equivocal or oligometastatic (< 5 metastasis) disease defined by conventional imagi
Number of metastases per compartment (bone, visceral, lymph node) that are discordant between conventional imaging and 18F-DCFPyL-PSMA -PET/CT.
Measured: through study completion, an average of 1 year
Determine the percentage of patients showing 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5) that were active on either baseline and 3-month PSMA-PET/CT (extension phase)
At V5, number of patients presenting with metastases determined by 18F-DCFPyL-PSMA PET/CT that were active on either baseline and 3-month PSMA-PET/CT
Measured: through study extension phase completion, an average of 1 year
In patients with 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5), determine the percentage of lesions that were NOT active on either baseline and 3-month PSMA-PET/CT (New lesions) (extension phase)
Number of metastases per compartment (bone, visceral, lymph node) at V5 imaging that were NOT active on either baseline and 3-month PSMA-PET/CT.
Number of metastases per compartment (bone, visceral, lymph node) that were active on either baseline and 3-month PSMA-PET/CT.
Measured: through study extension phase completion, an average of 1 year
Secondary outcomes (4)
Determine the intrapatient and interpatient 18F-DCFPyL-PSMA response rates defined by a 50% decrease in intralesional 18F-DCFPyL-PSMA uptake or 50% decrease in sum metastasis 18F-DCFPyL-PSMA uptake after 3 months of enzalutamide.
Determine the changes in 18F-DCFPyL-PSMA sum metastasis SUVmax (or any other radiomic PET parameter) for each patient and the changes of 18F-DCFPyL-PSMA SUVmax (or any other radiomic PET parameter) in each lesion after 3 months of enzalutamide.
Measured: At the end of study completion, an average of 2 years
Determine the impact of 18F-DCFPyL-PSMA PET/CT at progression (V5) on patient's management. (Extension phase)
Management plan prior and after the last 18F-DCFPyL-PSMA PET/CT (V5)
Measured: through study extension phase completion, an average of 1 year
In non-progressive patients defined by stable PSA, determine the percentage of patients showing active 18F-DCFPyL-PSMA PET/CT lesions at V5. (extension phases)
Number of patients presenting active 18F-DCFPyL-PSMA PET/CT lesions at V5 (among those who have not progressed).
Measured: through study extension phase completion, an average of 1 year
Determine how 18F-DCFPyL-PSMA PET/CT radiomics at baseline or 3 months after enzalutamide start can predict time to biochemical progression under enzalutamide. (extension phase)
Metastases SUVmax (or any other radiomics PET parameter) for each patient at baseline (V1) and 3 months after enzalutamide start (V3). Date of enzalutamide start and of biochemical progression
Measured: through study extension phase completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start22 Mar 2022
- Primary completion1 Nov 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Frédéric Pouliot, MD, Principal investigator, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655365
- Sponsor's protocol ID
- PROSTEP-002
- Acronym
- PROSTEP-002
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2020
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Monitoring of Metastasis by 18F-DCFPyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer and Negative, Equivocal, or Oligometastatic Disease on Conventional Imaging (PROSTEP-002)
- ClinicalTrials.gov ID
- NCT04655365
- Acronym / sponsor ID
- PROSTEP-002 / PROSTEP-002
- Conditions
- Prostate Cancer
- Keywords
- Untreated Castration Resistant Prostate Cancer, 18F-DCFPyL, Enzalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Astellas Pharma Europe Ltd.
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 7 Dec 2020 (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 study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging
Detailed description
Prostate cancer (PCa) is the most common solid organ cancer in North American men and is initially androgen sensitive. Therefore, castration and/or androgen receptor blockade remains the central palliative treatment once PCa has metastasized or failed to locoregional therapies. Because androgen deprivation therapy is not curative, all patients will eventually progress to the metastatic castration-resistant prostate cancer state. About 5% of prostate cancers will be metastatic by conventional imaging techniques at diagnosis while most patients achieving CRPC state will first be localized and then progress to metastatic state later in the disease course. Therefore, a significant proportion of patients will progress through an intermediary state of disease defined as the non-metastatic CRPC state (M0CRPC). Over the last year and a half, M0CRPC treatment landscape has completely changed with demonstrating the benefits of second-generation antiandrogens (darolutamide, enzalutamide and apalutamide) to prevent progression of M0CRPC patients. Enzalutamide have then been approved by the Federal Drug Administration and Health Canada for the treatment of M0CRPC.
On the other hand, conventional imaging techniques based on bone turnover (bone scan (BS)) or anatomical features (magnetic resonance imaging (MRI) or computed tomography (CT)) have important limitations and poor accuracy. Bone scans (BS) is the commonest imaging technique used to detect bone metastases in the clinics. BS does not image directly cancer cells, but the effect of cancer on the bone. Other pathologies such as fractures, degenerative arthritis and other benign bone lesions can also cause focal uptake on BS and lead to false-positive results. Another drawback of BS is its poor sensitivity to image small metastases confined to bone marrow. These limitations stress the importance to improve PCa imaging by using new imaging modalities.
Because novel agents targeting the androgen synthesis and receptor axis (e.g. enzalutamide), bone metastasis (radium-223) and microtubules assembly (docetaxel, cabazitaxel) have been shown to increase metastatic CRPC patients overall survival, a burning question is to determine if the non-metastatic CRPC status is real. There is growing evidence that newer imaging techniques using positron emission tomography can improve metastasis detection accuracy and may refine PCa patient prognostic stratification and treatment eligibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant Prostate Cancer and Negative, Equivocal or Oligometastatic Disease on Conventional Imaging | Experimental | Drug: Enzalutamide capsuleEnrolled subjects will receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL Injection followed by a single PET/CT scan acquired at 1-2 hours post-dosing. After initial 18F-DCFPyL PET/CT, the patients with positive 18F-DCFPyL PET/CT imaging will be treated with enzalutamide (160 mg po id) for M0CRPC disease within less than two weeks. 18F-DCFPyL PET/CT scan will then be repeated 90 days after the start of enzalutamide treatment. A final follow-up imaging (18F-DCFPyL PET/CT) at progression or at the final follow-up imaging examination at 18 months after the new complete ICF or in September 2026 (whichever comes first) will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed adenocarcinoma of the prostate per original diagnosis, with undergoing androgen deprivation therapy such as prior bilateral orchiectomy or surgical castration or LHRH-agonists/LHRH-antagonists.
- Suspected recurrence of prostate cancer based on rising PSA under androgen deprivation therapy. Recurrent castration resistant prostate cancer patients are defined by a rising PSA >1 ng/mL under ADT or surgical castration and with testosterone castration levels < 1.7 nM (PCWG3 criteria).
- Negative, equivocal findings or oligometastatic disease (< 5) for prostate cancer on conventional imaging bone scan AND 2) abdomen-pelvis CT/MRI and chest CT or FDG-PET/CT or 18F-NaF PET/CT performed as standard of care workup within 90 days of signing the ICF.
- The subject is candidate for second line androgen axis targeted inhibitors such as enzalutamide and planned to receive it.
- Life expectancy ≥6 months as determined by the investigator
Key exclusion criteria (17 listed)
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to study drug injection.
- Receipt of investigational drug therapy for prostate cancer within 60 days of Day 1.
- Known or suspected brain metastasis or active leptomeningeal disease.
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months before enrollment.
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 |
|---|---|---|
| Enzalutamide capsuleAlso: Xantdi160 mg po id | Drug | Resistant Prostate Cancer and Negative, Equivocal or Oligometastatic Disease on Conventional Imaging |
Primary outcome
Determine the percentage of patients presenting new metastatic lesions detected by 18F-DCFPyL-PSMA PET/CT in castration resistant prostate cancer patients presenting non metastatic, equivocal or oligometastatic (< 5 metastasis) disease
Time frame: Through study completion, an average of 1 year
Number of patients presenting with metastases per compartment (bone, visceral, lymph node) determined by 18F-DCFPyL-PSMA PET/CT that were negative or equivocal on conventional imaging. determined by 18F-DCFPyL-PET/CT.
Determine the number of discordant lesions between conventional and PSMA-PET/CT imaging in castration resistant prostate cancer patients presenting with non metastatic, equivocal or oligometastatic (< 5 metastasis) disease defined by conventional imagi
Time frame: through study completion, an average of 1 year
Number of metastases per compartment (bone, visceral, lymph node) that are discordant between conventional imaging and 18F-DCFPyL-PSMA -PET/CT.
Determine the percentage of patients showing 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5) that were active on either baseline and 3-month PSMA-PET/CT (extension phase)
Time frame: through study extension phase completion, an average of 1 year
At V5, number of patients presenting with metastases determined by 18F-DCFPyL-PSMA PET/CT that were active on either baseline and 3-month PSMA-PET/CT
In patients with 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5), determine the percentage of lesions that were NOT active on either baseline and 3-month PSMA-PET/CT (New lesions) (extension phase)
Time frame: through study extension phase completion, an average of 1 year
Number of metastases per compartment (bone, visceral, lymph node) at V5 imaging that were NOT active on either baseline and 3-month PSMA-PET/CT. Number of metastases per compartment (bone, visceral, lymph node) that were active on either baseline and 3-month PSMA-PET/CT.
4 secondary outcomes
Determine the intrapatient and interpatient 18F-DCFPyL-PSMA response rates defined by a 50% decrease in intralesional 18F-DCFPyL-PSMA uptake or 50% decrease in sum metastasis 18F-DCFPyL-PSMA uptake after 3 months of enzalutamide.
Time frame: At the end of study completion, an average of 2 years
Determine the impact of 18F-DCFPyL-PSMA PET/CT at progression (V5) on patient's management. (Extension phase)
Time frame: through study extension phase completion, an average of 1 year
In non-progressive patients defined by stable PSA, determine the percentage of patients showing active 18F-DCFPyL-PSMA PET/CT lesions at V5. (extension phases)
Time frame: through study extension phase completion, an average of 1 year
Determine how 18F-DCFPyL-PSMA PET/CT radiomics at baseline or 3 months after enzalutamide start can predict time to biochemical progression under enzalutamide. (extension phase)
Time frame: through study extension phase completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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. This study is not recruiting at the moment.
Frédéric Pouliot, MD principal investigator
CHU de Québec-Université Laval
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide capsule in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 4 sites in Canada.
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 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 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 4 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the percentage of patients presenting new metastatic lesions detected by 18F-DCFPyL-PSMA PET/CT in castration resistant prostate cancer patients presenting non metastatic, equivocal or oligometastatic (< 5 metastasis) disease (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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.