Prostate CancerPRAISE-UNCT06424275
Prostate Cancer Awareness and Initiative for Screening in the European Union
An observational study of Prostate Cancer, run by European Association of Urology Research Foundation at 5 sites in 4 countries.
Trial summary
PRAISE-U was initiated on the 1st of April 2023 and is set to last for three years. This collaborative effort involves 25 institutions across 12 countries, all driven by a shared objective: to rationalize prostate cancer screening in Europe and enhance patient outcomes. Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Risk-based screening algorithm
- How many people
- 20,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Jun 2024to 1 Apr 2026
- Phase
- Observational
- 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 50 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men aged 50-69 years old.
Who may be able to join
- Age 50-69 years old.
Who cannot join
- Previous diagnosis of prostate cancer.
- Unable to provide written informed consent.
- Had prostate biopsy or MRI within the past six months.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Spain2 sites
Althaia Foundation
Manresa
Public Health Directorate, SERGAS
Santiago de Compostela, Galicia
Poland1 site
Lower Silesian Oncology, Pulmonology and Hematology Center
Wroclaw, Lower Silesian Voivodeship
About this study
PRAISE-U was initiated on the 1st of April 2023 and is set to last for three years. This collaborative effort involves 25 institutions across 12 countries, all driven by a shared objective: to rationalize prostate cancer screening in Europe and enhance patient outcomes. PRAISE-U advocates for EU member states to offer exceptional clinical standards, incorporating cutting-edge personalized approaches to enable timely detection of prostate cancer in individuals who can benefit from early treatment. To assess the functionality, feasibility, and long-term viability of a risk-based algorithm, the consortium will collaborate with pilot sites in Spain, Poland, Ireland, and Lithuania.
Read the detailed description
The project has several key deliverables that are instrumental in its success. In the early phase of the project, the consortium will prepare a living state-of-play document - a comprehensive review of diverse screening strategies for prostate cancer in the EU, as well their harm/benefit and cost effectiveness. At a later stage, clinical performance indicators of screening effectiveness will be established, and a protocol for implementation of population-based quality assured prostate cancer screening program will be developed. While the protocol will follow a standardized approach, it will also allow for flexibility to accommodate the unique characteristics of each country's healthcare system. The pilot studies will run for 12 months, and all collected data will be used to estimate pre-defined key performance indicators that will be included in the final report. This deliverable will be used to perform a thorough evaluation of how well the screening program worked during the pilot phase and how site characteristics and diagnostic algorithms are associated with performance. The reach, acceptability, and adoption of the screening programme, its cost-effectiveness, as well as attitudes of participants and physicians, will be the research outcomes of interest.
The project aims to have short-term and long-term effects on prostate cancer screening in EU member states. In the short-term (1-3 years), the focus is on advancing population-based risk-adapted prostate cancer screening and increasing awareness among key stakeholders. This will be achieved by providing evidence-based information on the benefits and drawbacks of risk-adapted screening, leading to improved knowledge and future endorsement by healthcare professionals. In the medium-term (4-9 years), the goal is to reduce costs by eliminating ineffective opportunistic screening and implementing an organized risk-based screening algorithm. Ultimately, in the long-term (10+ years), the project aims to decrease the burden of prostate cancer and improve quality of life by reducing mortality rates and the number of advanced/metastatic cases through effective screening practices. PRAISE-U is an important step in assessing how screening for prostate cancer may reduce the burden of the disease for every man in the European Union.
- Conditions
- Prostate Cancer
- Being tested
- Risk-based screening algorithm
- Keywords
- prostate cancer, early detection of prostate cancer, cancer screening, risk-based algorithm
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-based screening algorithmDiagnostic test
Also called PSA, Risk calculator, MRI, Biopsy
Risk-based screening algorithm
| Study group | Role | What they receive |
|---|---|---|
| Manresa, Spain | The pilot is run by the Althaia Foundation, driven by the director of primary care. Receives: Diagnostic Test: Risk-based screening algorithm | |
| Region Galicia, Spain | The pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain. Receives: Diagnostic Test: Risk-based screening algorithm | |
| Ireland | The pilot is run by the Health Service Executive, with University College Dublin as the academic institutional partner, in full support of the National Cancer Control programme (NCCP) and the National Screening Service (NSS) in Ireland Receives: Diagnostic Test: Risk-based screening algorithm | |
| Poland | The pilot is run by the Lower Silesian Oncology, Pulmonology and Haematology Center. Subdivision of Urology with support from the National Institute of Public Health. Receives: Diagnostic Test: Risk-based screening algorithm | |
| Lithuania | The pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served. Receives: Diagnostic Test: Risk-based screening algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
Measured: 1 year
Invitation coverage
The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
Measured: 1 year
Examination coverage
The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
Measured: 1 year
Participation rate
The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
Measured: 1 year
Retention rate
The proportion of eligible individuals re-screened after a negative screening within a specified interval.
Measured: 1 year
Test result
The results of the screening test.
Measured: 1 year
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
The proportion of individuals who have histopathology confirmed PCa to all those who had positive test results (with PSA result of >3 ng/ml) (including healthy subjects who were incorrectly diagnosed to have prostate cancer)
Measured: 1 year
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
The proportion of individuals who have histopathologically confirmed clinically significant PCa to all those who had positive test results (with PSA result of >3 ng/ml)
(including healthy subjects who were incorrectly diagnosed as clinically significant PCa).
Measured: 1 year
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.
Measured: 1 year
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.
Measured: 1 year
Compliance with risk assessment
The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
Measured: 1 year
Compliance with further assessment
The proportion of individuals referred for diagnostic work up based on elevated PSA and risk assessment (as per protocol of the programme) attending all workup and diagnostic procedures assigned.
Measured: 1 year
Detection rate of PCa
The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected [expressed per 1,000 individuals screened].
Measured: 1 year
Compliance with treatment
The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).
Measured: 1 year
Complications in screening procedure
The proportion of individuals reporting at least one complication incurred during the screening procedure.
Measured: 1 year
Opportunistic testing
The proportion of individuals screened outside the population-based screening programme.
Measured: 1 year
Cause-specific mortality
The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period
Measured: 1 year
Crude Incidence rate
The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.]
Measured: 1 year
Interval cancer rate
The proportion of individuals with a negative screening test or a positive screening test but negative further assessment results who were diagnosed with prostate cancer prior to the next screening round.
Measured: 1 year
Delay time
Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation
Measured: 1 year
Radiologist's assessment of MRI
Radiologist's assessment of MRI
Measured: 1 year
Compliance with biopsy
Proportion of eligible men who underwent biopsy
Measured: 1 year
Active surveillance
The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
Measured: 1 year
Tumour grade distribution
Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jun 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Association of Urology Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, European Randomised Study of Screening for Prostate Cancer, Region MidtJylland Denmark, Institute of Health Information and Statistics of the Czech Republic, UMC Utrecht, EUROPEAN CANCER ORGANISATION, Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii, Narodowy Instytut Zdrowia Publicznego, Conselleria de Sanidade de Galicia, Althaia Xarxa Assistencial Universitària de Manresa, Vastra Gotaland Region, Region Skane, National Cancer Institute (NCI), University Ghent, Health Service Executive, Ireland, Estonian Urological Association, University College Dublin, WONCA Europe, Movember Foundation, International Agency for Research on Cancer, European Society of Urogenital Radiology, Europa UOMO, Czech Urological Society
- Responsible party
- Sponsor
- Investigators
- Hendrik Van Poppel, Prof, Study director, European Association of Urology and KULeuvenMonique J Roobol, Prof, Principal investigator, Erasmus MC Cancer Institute Dep of Urology and European Association of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424275
- Sponsor's protocol ID
- 101101217
- Acronym
- PRAISE-U
- Status last verified
- Aug 2025
- First submitted
- 16 May 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data data sharing is not foreseen in the informed consent form, however, de-identified patient data will be shared for research purposes.
Publications
Palaniraja S, Mosquera I, Carvalho AL, Singh D, Vilaseca J, Patasius A, Tupikowski K, Amorin AG, Tarrazo Antelo AM, Quinteiro MC, Galvin D, van den Bergh R, Roobol MJ, FrancellaVenderbos LD, Collen S, van Poppel H, Basu P, Chandran A; PRAISE-U consortiuml; PRAISE-U consortium. Mapping the readiness landscape for prostate cancer screening in Europe: analysis of health system capacity across the PRAISE-U pilots. EClinicalMedicine. 2026 Aug 6;99:104093. doi: 10.1016/j.eclinm.2026.104093. eCollection 2026 Sep.
PubMed 42802883
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Awareness and Initiative for Screening in the European Union
- ClinicalTrials.gov ID
- NCT06424275
- Acronym / sponsor ID
- PRAISE-U / 101101217
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, early detection of prostate cancer, cancer screening, risk-based algorithm
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- European Association of Urology Research FoundationUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, European Randomised Study of Screening for Prostate Cancer, Region MidtJylland Denmark, Institute of Health Information and Statistics of the Czech Republic, UMC Utrecht, EUROPEAN CANCER ORGANISATION, Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii, Narodowy Instytut Zdrowia Publicznego, Conselleria de Sanidade de Galicia, Althaia Xarxa Assistencial Universitària de Manresa, Vastra Gotaland Region, Region Skane, National Cancer Institute (NCI), University Ghent, Health Service Executive, Ireland, Estonian Urological Association, University College Dublin, WONCA Europe, Movember Foundation, International Agency for Research on Cancer, European Society of Urogenital Radiology, Europa UOMO, Czech Urological Society
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 22 May 2024 (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.
PRAISE-U was initiated on the 1st of April 2023 and is set to last for three years. This collaborative effort involves 25 institutions across 12 countries, all driven by a shared objective: to rationalize prostate cancer screening in Europe and enhance patient outcomes. PRAISE-U advocates for EU member states to offer exceptional clinical standards, incorporating cutting-edge personalized approaches to enable timely detection of prostate cancer in individuals who can benefit from early treatment. To assess the functionality, feasibility, and long-term viability of a risk-based algorithm, the consortium will collaborate with pilot sites in Spain, Poland, Ireland, and Lithuania.
Detailed description
The project has several key deliverables that are instrumental in its success. In the early phase of the project, the consortium will prepare a living state-of-play document - a comprehensive review of diverse screening strategies for prostate cancer in the EU, as well their harm/benefit and cost effectiveness. At a later stage, clinical performance indicators of screening effectiveness will be established, and a protocol for implementation of population-based quality assured prostate cancer screening program will be developed. While the protocol will follow a standardized approach, it will also allow for flexibility to accommodate the unique characteristics of each country's healthcare system. The pilot studies will run for 12 months, and all collected data will be used to estimate pre-defined key performance indicators that will be included in the final report. This deliverable will be used to perform a thorough evaluation of how well the screening program worked during the pilot phase and how site characteristics and diagnostic algorithms are associated with performance. The reach, acceptability, and adoption of the screening programme, its cost-effectiveness, as well as attitudes of participants and physicians, will be the research outcomes of interest.
The project aims to have short-term and long-term effects on prostate cancer screening in EU member states. In the short-term (1-3 years), the focus is on advancing population-based risk-adapted prostate cancer screening and increasing awareness among key stakeholders. This will be achieved by providing evidence-based information on the benefits and drawbacks of risk-adapted screening, leading to improved knowledge and future endorsement by healthcare professionals. In the medium-term (4-9 years), the goal is to reduce costs by eliminating ineffective opportunistic screening and implementing an organized risk-based screening algorithm. Ultimately, in the long-term (10+ years), the project aims to decrease the burden of prostate cancer and improve quality of life by reducing mortality rates and the number of advanced/metastatic cases through effective screening practices. PRAISE-U is an important step in assessing how screening for prostate cancer may reduce the burden of the disease for every man in the European Union.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Manresa, Spain | – | Diagnostic Test: Risk-based screening algorithmThe pilot is run by the Althaia Foundation, driven by the director of primary care. |
| Region Galicia, Spain | – | Diagnostic Test: Risk-based screening algorithmThe pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain. |
| Ireland | – | Diagnostic Test: Risk-based screening algorithmThe pilot is run by the Health Service Executive, with University College Dublin as the academic institutional partner, in full support of the National Cancer Control programme (NCCP) and the National Screening Service (NSS) in Ireland |
| Poland | – | Diagnostic Test: Risk-based screening algorithmThe pilot is run by the Lower Silesian Oncology, Pulmonology and Haematology Center. Subdivision of Urology with support from the National Institute of Public Health. |
| Lithuania | – | Diagnostic Test: Risk-based screening algorithmThe pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men aged 50-69 years old.
Key inclusion criteria (1 listed)
- Age 50-69 years old.
Key exclusion criteria (3 listed)
- Previous diagnosis of prostate cancer.
- Unable to provide written informed consent.
- Had prostate biopsy or MRI within the past six months.
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 |
|---|---|---|
| Risk-based screening algorithmAlso: PSA, Risk calculator, MRI, BiopsyRisk-based screening algorithm | Diagnostic test | Ireland, Lithuania, Manresa, Spain, Poland, Region Galicia, Spain |
Primary outcome
Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
Time frame: 1 year
Invitation coverage
Time frame: 1 year
The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
Examination coverage
Time frame: 1 year
The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
Participation rate
Time frame: 1 year
The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
Retention rate
Time frame: 1 year
The proportion of eligible individuals re-screened after a negative screening within a specified interval.
Test result
Time frame: 1 year
The results of the screening test.
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
Time frame: 1 year
The proportion of individuals who have histopathology confirmed PCa to all those who had positive test results (with PSA result of >3 ng/ml) (including healthy subjects who were incorrectly diagnosed to have prostate cancer)
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
Time frame: 1 year
The proportion of individuals who have histopathologically confirmed clinically significant PCa to all those who had positive test results (with PSA result of >3 ng/ml) (including healthy subjects who were incorrectly diagnosed as clinically significant PCa).
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
Time frame: 1 year
The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
Time frame: 1 year
The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.
Compliance with risk assessment
Time frame: 1 year
The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
Compliance with further assessment
Time frame: 1 year
The proportion of individuals referred for diagnostic work up based on elevated PSA and risk assessment (as per protocol of the programme) attending all workup and diagnostic procedures assigned.
Detection rate of PCa
Time frame: 1 year
The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected [expressed per 1,000 individuals screened].
Compliance with treatment
Time frame: 1 year
The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).
Complications in screening procedure
Time frame: 1 year
The proportion of individuals reporting at least one complication incurred during the screening procedure.
Opportunistic testing
Time frame: 1 year
The proportion of individuals screened outside the population-based screening programme.
Cause-specific mortality
Time frame: 1 year
The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period
Crude Incidence rate
Time frame: 1 year
The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.]
Interval cancer rate
Time frame: 1 year
The proportion of individuals with a negative screening test or a positive screening test but negative further assessment results who were diagnosed with prostate cancer prior to the next screening round.
Delay time
Time frame: 1 year
Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation
Radiologist's assessment of MRI
Time frame: 1 year
Radiologist's assessment of MRI
Compliance with biopsy
Time frame: 1 year
Proportion of eligible men who underwent biopsy
Active surveillance
Time frame: 1 year
The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
Tumour grade distribution
Time frame: 1 year
Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 42802883Palaniraja S, Mosquera I, Carvalho AL, Singh D, Vilaseca J, Patasius A, Tupikowski K, Amorin AG, Tarrazo Antelo AM, Quinteiro MC, Galvin D, van den Bergh R, Roobol MJ, FrancellaVenderbos LD, Collen S, van Poppel H, Basu P, Chandran A; PRAISE-U consortiuml; PRAISE-U consortium. Mapping the readiness landscape for prostate cancer screening in Europe: analysis of health system capacity across the PRAISE-U pilots. EClinicalMedicine. 2026 Aug 6;99:104093. doi: 10.1016/j.eclinm.2026.104093. eCollection 2026 Sep.
- Links to all PRAISE U publicationsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Patient Data data sharing is not foreseen in the informed consent form, however, de-identified patient data will be shared for research purposes.
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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.
Hendrik Van Poppel, Prof study director
European Association of Urology and KULeuven
Monique J Roobol, Prof principal investigator
Erasmus MC Cancer Institute Dep of Urology and European Association of Urology
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by European Association of Urology Research Foundation at 5 sites in 4 countries.
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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Ireland, Lithuania, Poland. 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?
Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2). (time frame: 1 year). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.