Adenocarcinoma of the ProstatePhase 3ProVentNCT03686683
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
A Phase 3 study testing sipuleucel-T in people with Adenocarcinoma of the Prostate, run by Dendreon at 56 sites in United States.
Trial summary
The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to participants followed on active surveillance as standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- sipuleucel-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 56 sitesUnited States
- Study dates
- 18 Oct 2018to 10 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Age is ≥ 18 years
- 2. Written informed consent provided prior to the initiation of study procedures
- 3. Histologically proven adenocarcinoma of the prostate initially diagnosed ≤12 months of Screening. All biopsy slides with participant information redacted must be submitted for blinded independent central review (BICR).
- 4. Prostate cancer diagnosis determined by BICR as one of the following: 4a. ISUP Grade Group 1 with 3 or more cores positive from a systematic (≥10 cores) biopsy 4b. ISUP Grade Group 1 with ≥ 1 core positive with ≥50% cancer involvement from a systematic (≥10 cores) biopsy 4c. ISUP Grade Group 1 from 3 or more positive cores from any combination of cores from a systematic (≥10 cores) biopsy and MRI targeted biopsy (note: multiple cores from each MRI targeted lesion will count as 1 core) 4d. ISUP Grade Group 1 from a negative systematic (≥10 cores) biopsy and an MRI targeted core positive with ≥50% cancer involvement 4e. ISUP Grade Group 2 from a systematic (≥10 cores) biopsy with <50% of the total number of any cores positive for cancer 4f. ISUP Grade Group 2 from a negative systematic (≥10 cores) biopsy and MRI targeted core(s) positive for Gleason 3+4 (see note below) 4g. ISUP Grade Group 2 from any combination of cores from a systematic (≥10 cores) biopsy and MRI targeted biopsy (see note below)
- Note for 4f and 4g: the total number of positive cores must be <50% of total cores from both the systematic biopsy and MRI targeted lesions; each MRI targeted lesion, irrespective of multiple positive cores, will each count as 1 core for the total number of positive cores, e.g., 4 targeted lesions with 2 positive cores each will only add 4 to the total core count.
- 5. Participant consents to standard of care for biopsy frequency of 2 on-study prostate biopsies and to provide biopsy tissue for study endpoint analysis.
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- 6. Estimated life expectancy ≥ 10 years
- 7. Candidate for primary curative therapy (e.g., surgery or radiation) if prostate cancer progression occurs
- 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 9. Adequate baseline hematologic, renal, and liver function tests as evidenced by laboratory test results within the following ranges ≤30 days prior to randomization White blood cell (WBC) count ≥ 3.0 x 10^6 cells/mL Absolute neutrophil count (ANC) ≥ 1.5 x 10^6 cells/mL Platelet count ≥ 1.0 x10^5 cells/uL Hemoglobin (Hgb) ≥ 10.0 g/dL Creatinine ≤ 1.5 mg/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤ 2.0 x ULN Aspartate aminotransferase (AST) ≤ 2.0 x ULN
Who cannot join
- 1. Former therapy for prostate cancer (local or systemic)
- 2. Any previous prostatic surgical procedure that significantly changes the anatomy of prostate (at the discretion of sponsor's Medical Monitor)
- 3. Any investigational product received for prostate cancer
- 4. Prostate biopsy specimen reveals neuroendocrine or small cell features
- 5. Primary Gleason score is ≥ 4 or any Gleason pattern 5
- 6. Any evidence of locally advanced, regional or metastatic disease, including regional and distant lymph node enlargement (Nodes ≥1.5 cm in the short axis are considered pathologic and measurable)
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- 7. A history of a cerebrovascular event (CVE) or transient ischemic attack (TIA)
- 8. Participant has used a 5-alpha-reductase inhibitor (e.g., finasteride or dutasteride) continuously for ≥ 6 months and within 6 months prior to study Screening
- 9. Participant has a history of any other stage I-IV malignancy, except for basal or squamous cell skin cancer. The Participant must be disease free and off any malignancy-related treatment for at least 5 years.
- 10. Participant has prior use within 30 days of study Screening of any herbal, dietary, or alternative anti-cancer treatment or product, such as PC-SPES (or PC-x product), saw palmetto, ketoconazole, an estrogen-containing nutraceutical, or high dose calcitriol (>0.5 μg/day). The Investigator will consider herbal therapies on a case-by-case basis to determine whether they fall into the category of prohibited medications based on their potential for hormonal or anti-cancer or anti-cancer properties.
- 11. Need for systemic chronic immunosuppressive therapy (e.g., anti-tumor necrosis factor alpha monoclonal antibodies, glucocorticoids)
- 12. Uncontrolled, concurrent illness including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), symptomatic congestive heart failure (New York Classification III-IV) or unstable angina pectoris within the last 6 months, or psychiatric illness that would limit compliance with study requirements as well as any condition that would preclude a participant from undergoing leukapheresis (e.g., within the previous 6 months: myocardial infarction, interventional cardiology procedure such as angioplasty or stent placement, pulmonary embolism or deep vein thrombosis).
- 13. Hypogonadal (T <175 ng/dL) or on continuous testosterone replacement therapy
- 14. Positive serology for HIV-1, HIV-2 or human T-lymphotropic virus (HTLV)-1, HTLV-2
- 15. Active hepatitis B or C
- 16. Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator or the sponsor's Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109
University of Colorado Hospital Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Cook County Health
Chicago, Illinois, 60612
Rush University
Chicago, Illinois, 60612
Research by Design
Chicago, Illinois, 60643
The Urology Group - Norwood Campus
Cincinnati, Ohio, 45212
Mary Crowley Cancer Research
Dallas, Texas, 75230
Advanced Urology Institute
Daytona Beach, Florida, 32114
The Urology Center of Colorado
Denver, Colorado, 80211
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Gottlieb Memorial Hospital
Glenview, Illinois, 60026
NorthShore University HealthSystem
Glenview, Illinois, 60026
Foothills Urology- Golden Office
Golden, Colorado, 80401
First Urology
Jeffersonville, Indiana, 47130
Advanced Urology Associates
Joliet, Illinois, 60431
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
Lancaster Urology
Lancaster, Pennsylvania, 17604
Arkansas Urological Associates, PA
Little Rock, Arkansas, 72211
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Integrated Medical Professionals, PLLC
Melville, New York, 11747
Delaware Valley Urology
Mount Laurel, New Jersey, 08054
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates
Nashville, Tennessee, 37209
Vanderbilt University
Nashville, Tennessee, 37232
Tulane University
New Orleans, Louisiana, 70112
Mount Sinai Health System
New York, New York, 10029
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Adult Pediatric Urology and Urogynecology - Omaha
Omaha, Nebraska, 68114
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
University of California Irvine
Orange, California, 92868
Kansas City Urology Care, PA
Overland Park, Kansas, 66211
Associated Urologists of North Carolina - Raleigh
Raleigh, North Carolina, 27612
Virginia Urology
Richmond, Virginia, 23235
Advanced Urology Institute of Georgia
Roswell, Georgia, 30076
Urology San Antonio
San Antonio, Texas, 78229
John Wayne Cancer Institute
Santa Monica, California, 90404
Virginia Mason Medical Center
Seattle, Washington, 98101
Regional Urology, LLC
Shreveport, Louisiana, 71106
The Urology Group
Southaven, Mississippi, 38671
Oregon Urology Institute Research
Springfield, Oregon, 97477
Washington University School of Medicine
St Louis, Missouri, 63110
Associated Medical Professionals of NY, PLLC (AMP)
Syracuse, New York, 13210
Skyline Urology
Torrance, California, 90505
Chesapeake Urology
Towson, Maryland, 21204
Michigan Institute of Urology, PC
Troy, Michigan, 48084
Arizona Institute of Urology
Tucson, Arizona, 85741
Urological Associates of Southern Arizona - East Office
Tucson, Arizona, 85741
Urology of Virginia
Virginia Beach, Virginia, 23462
Omega Medical Research
Warwick, Rhode Island, 02886
Iowa Clinical Research Corp.
West Des Moines, Iowa, 50266
Wichita Urology Group Research
Wichita, Kansas, 67226
About this study
Official title: A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer
The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to participants followed on active surveillance as standard of care.
Read the detailed description
The ProVent Study is designed to look at participants who receive sipuleucel-T compared to control participants followed on active surveillance (AS). The study will enroll participants being followed by AS and initially diagnosed within 12 months prior to Screening with either International Society of Urological Pathology (ISUP) Grade Group 1 or 2 adenocarcinoma of the prostate.
The Screening Phase will begin at the completion of the informed consent process and continues until randomization. After Screening assessments are completed, eligible participants will be randomized 2:1 to the sipuleucel-T arm or the control arm. Participants randomized to sipuleucel-T arm will receive product as described in the sipuleucel-T approved label.
Participants will undergo their first leukapheresis within 60 days of randomization.
Participants randomized to the control arm will be followed on AS. The Active Phase will begin at randomization and continues through completion of the end of Active Phase study visit (within 30 days of Biopsy 2). Once a Participant from either the sipuleucel-T or control arms completes the end of Active Phase visit, they will enter the Follow-up Phase and complete Follow-up Phase visits every 6 months starting from their last Active Phase visit. The Follow-up Phase visits end when the last Participant enrolled completes Biopsy 2 and end of Active Phase visit or until the study is terminated by the sponsor.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- sipuleucel-T
- Keywords
- ISUP Grade Group 1 or 2, Number biopsies 1 or >1 (≤12 months of Screening)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sipuleucel-TBiological
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with recombinant fusion protein composed PAP linked to GM-CSF (PA2024), a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group: Sipuleucel-T | Experimental | Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Participants randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. Receives: Biological: sipuleucel-T |
| Control Arm: Active Surveillance | No intervention | Participants randomized to the control arm will be followed on Active Surveillance described in the schedule of events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade).
Percentage of participants without histological reclassification (Gleason group upgrade) within 36 months of randomization as determined by Blinded Independent Central Review (BICR)
- Upgrade is defined as participants at randomization with either International Society of Urological Pathology (ISUP) Grade Group 1 (Gleason 3+3) upgraded to Grade Group 2 (Gleason 3+4) or higher or participants at randomization with Grade Group 2 upgraded to Grade Group 3 (Gleason 4+3) or higher.
Measured: Once all participants have completed at least 3 years following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start18 Oct 2018
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies 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
- Model description
- Participants will be randomized 2:1 to the sipuleucel-T arm or the control arm.Participants randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. Participants randomized to the control arm will be followed on AS as standard of care described in the schedule of events.
- Masking
- None (open label)
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Nadeem Sheikh, PhD, Study director, Dendreon Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686683
- Sponsor's protocol ID
- P17-1
- Other IDs
- ProVent
- Acronym
- ProVent
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2018
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer
- ClinicalTrials.gov ID
- NCT03686683
- Acronym / sponsor ID
- ProVent / P17-1
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- ISUP Grade Group 1 or 2, Number biopsies 1 or >1 (≤12 months of Screening)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to participants followed on active surveillance as standard of care.
Detailed description
The ProVent Study is designed to look at participants who receive sipuleucel-T compared to control participants followed on active surveillance (AS). The study will enroll participants being followed by AS and initially diagnosed within 12 months prior to Screening with either International Society of Urological Pathology (ISUP) Grade Group 1 or 2 adenocarcinoma of the prostate.
The Screening Phase will begin at the completion of the informed consent process and continues until randomization. After Screening assessments are completed, eligible participants will be randomized 2:1 to the sipuleucel-T arm or the control arm. Participants randomized to sipuleucel-T arm will receive product as described in the sipuleucel-T approved label.
Participants will undergo their first leukapheresis within 60 days of randomization.
Participants randomized to the control arm will be followed on AS. The Active Phase will begin at randomization and continues through completion of the end of Active Phase study visit (within 30 days of Biopsy 2). Once a Participant from either the sipuleucel-T or control arms completes the end of Active Phase visit, they will enter the Follow-up Phase and complete Follow-up Phase visits every 6 months starting from their last Active Phase visit. The Follow-up Phase visits end when the last Participant enrolled completes Biopsy 2 and end of Active Phase visit or until the study is terminated by the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 2:1 to the sipuleucel-T arm or the control arm.Participants randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. Participants randomized to the control arm will be followed on AS as standard of care described in the schedule of events.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group: Sipuleucel-T | Experimental | Biological: sipuleucel-TSipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Participants randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. |
| Control Arm: Active Surveillance | No intervention | –Participants randomized to the control arm will be followed on Active Surveillance described in the schedule of events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Age is ≥ 18 years
- 2. Written informed consent provided prior to the initiation of study procedures
- 3. Histologically proven adenocarcinoma of the prostate initially diagnosed ≤12 months of Screening. All biopsy slides with participant information redacted must be submitted for blinded independent central review (BICR).
- 4. Prostate cancer diagnosis determined by BICR as one of the following: 4a. ISUP Grade Group 1 with 3 or more cores positive from a systematic (≥10 cores) biopsy 4b. ISUP Grade Group 1 with ≥ 1 core positive with ≥50% cancer involvement from a systematic (≥10 cores) biopsy 4c. ISUP Grade Group 1 from 3 or more positive cores from any combination of cores from a systematic (≥10 cores) biopsy and MRI targeted biopsy (note: multiple cores from each MRI targeted lesion will count as 1 core) 4d. ISUP Grade Group 1 from a negative systematic (≥10 cores) biopsy and an MRI targeted core positive with ≥50% cancer involvement 4e. ISUP Grade Group 2 from a systematic (≥10 cores) biopsy with <50% of the total number of any cores positive for cancer 4f. ISUP Grade Group 2 from a negative systematic (≥10 cores) biopsy and MRI targeted core(s) positive for Gleason 3+4 (see note below) 4g. ISUP Grade Group 2 from any combination of cores from a systematic (≥10 cores) biopsy and MRI targeted biopsy (see note below)
- Note for 4f and 4g: the total number of positive cores must be <50% of total cores from both the systematic biopsy and MRI targeted lesions; each MRI targeted lesion, irrespective of multiple positive cores, will each count as 1 core for the total number of positive cores, e.g., 4 targeted lesions with 2 positive cores each will only add 4 to the total core count.
Key exclusion criteria (16 listed)
- 1. Former therapy for prostate cancer (local or systemic)
- 2. Any previous prostatic surgical procedure that significantly changes the anatomy of prostate (at the discretion of sponsor's Medical Monitor)
- 3. Any investigational product received for prostate cancer
- 4. Prostate biopsy specimen reveals neuroendocrine or small cell features
- 5. Primary Gleason score is ≥ 4 or any Gleason pattern 5
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 |
|---|---|---|
| sipuleucel-TSipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with recombinant fusion protein composed PAP linked to GM-CSF (PA2024), a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). | Biological | Treatment Group: Sipuleucel-T |
Primary outcome
Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade).
Time frame: Once all participants have completed at least 3 years following randomization
Percentage of participants without histological reclassification (Gleason group upgrade) within 36 months of randomization as determined by Blinded Independent Central Review (BICR) o Upgrade is defined as participants at randomization with either International Society of Urological Pathology (ISUP) Grade Group 1 (Gleason 3+3) upgraded to Grade Group 2 (Gleason 3+4) or higher or participants at randomization with Grade Group 2 upgraded to Grade Group 3 (Gleason 4+3) or higher.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nadeem Sheikh, PhD study director
Dendreon Pharmaceuticals, LLC
56 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 sipuleucel-T in people with Adenocarcinoma of the Prostate, run by Dendreon at 56 sites 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 10 inclusion and 16 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade). (time frame: Once all participants have completed at least 3 years following randomization). 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 8 Oct 2024.