Prostate CancerTAPGNCT03912883
Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
An observational study of Prostate Cancer, run by Queen Mary University of London.
Trial summary
The Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might… Read more about this study
- Who is it for?
- Ages 18 to 76 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 3,350 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 1999to 1 Jan 2030
- 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 18 to 76 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective, exploratory cohort study and will be carried out in patients registered on UK regional cancer registry databases, as having been diagnosed with prostate cancer between 1990 and 2006, inclusive.
Who may be able to join
- Patients must be aged less than 76 years at the time of diagnosis
- Patients must have had a baseline serum PSA level measured before starting any treatment and within six months of diagnosis
- Patients must have been diagnosed between 1990 and 2006 with a clinically localized (clinical stage T1-T3, N0 or NX, MO or MX) prostate cancer, in the judgment of the treating physician
- The initial diagnostic biopsy sample must be available for review. Patients should have (but are not required to have) tissue blocks available for review.
- There must be no evidence of metastatic disease
- While data collection will include review of the reports of any imaging studies of the prostate, bones, or soft tissues, these studies are not essential
- Each patient should have had an adequate medical evaluation to document the status of disease for the first five years after diagnosis. Follow-up should include an annual PSA and digital rectal examination. Records will be reviewed to seek all information about medical evaluation after the time of diagnosis.
Who cannot join
- Patients older than 76 years at the time of diagnosis
- Patients who have not had a baseline serum PSA level measured before starting any treatment
- Patients who do not have the initial diagnosis biopsy sample for review
- Patients with evidence of metastatic disease
About this study
The Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised prostate cancer.
Read the detailed description
In 1999, the TAPG group initiated the "Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting" study, referred to as the TAPG study. It is a retrospective population-based tissue sample study in men diagnosed with localised prostate cancer 1990-2006, inclusively. Initially the cohort comprised men diagnosed with prostate cancer with transurethral resection of the prostate (TURP) and needle biopsies 1990-1996, but was expanded from 2005 to include men diagnosed with prostate cancer 1990 - 2006. Data was collected from six regional cancer registries and eligibility was confirmed via hospital sites, which sent the relevant tissue samples to the TAPG Central Coordinating Office (CCO). Selection of eligible patients for the study completed in 2010. Since this year the TAPG CCO has been collecting cancer registration and mortality updates on the cohort members from regional cancer registries.
- Conditions
- Prostate Cancer
- Keywords
- biomarkers, pathology, tissue, watchful waiting, active surveillance
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific survival
Time from date of inclusion until death from prostate cancer.
Measured: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
Overall survival
Time from date of inclusion until death from any cause.
Measured: From date of inclusion to date of death from any cause, assessed up to 30 years.
Secondary outcomes (6)
To evaluate a correlation between serum PSA level and prostate cancer-specific survival.
Correlation of serum PSA level taken within 6 months of date of inclusion compared to death from prostate cancer.
Measured: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate a correlation between Gleason score and prostate cancer-specific survival.
Correlation of Gleason Score at date of inclusion compared to death from prostate cancer.
Measured: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate an association between clinical stage and prostate cancer-specific survival.
Stratification of clinical stage at date of inclusion compared to death from prostate cancer.
Measured: From date of inclusion to date of death from any cause, assessed up to 30 years.
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
Correlation of ki-67-positive cells compared to prostate cancer-specific survival.
Measured: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
Correlation of ki-67-positive cells compared to overall cancer-specific survival.
Measured: From date of inclusion to date of death from any cause, assessed up to 30 years.
To evaluate ERG-ETV1 biomarker predictors of prognosis in early prostate cancer.
Correlation of ERG-ETV1 rearrangement status compared to prostate cancer-specific survival.
Measured: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start12 Oct 1999
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912883
- Sponsor's protocol ID
- 005937
- Acronym
- TAPG
- Status last verified
- Nov 2025
- First submitted
- 14 Feb 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beltran L, Ahmad AS, Sandu H, Kudahetti S, Soosay G, Moller H, Cuzick J, Berney DM; Transatlantic Prostate Group. Histopathologic False-positive Diagnoses of Prostate Cancer in the Age of Immunohistochemistry. Am J Surg Pathol. 2019 Mar;43(3):361-368. doi: 10.1097/PAS.0000000000001202.
PubMed 30531531Ahmad AS, Parameshwaran V, Beltran L, Fisher G, North BV, Greenberg D, Soosay G, Moller H, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Should reporting of peri-neural invasion and extra prostatic extension be mandatory in prostate cancer biopsies? correlation with outcome in biopsy cases treated conservatively. Oncotarget. 2018 Apr 17;9(29):20555-20562. doi: 10.18632/oncotarget.24994. eCollection 2018 Apr 17.
PubMed 29755671Stankiewicz E, Mao X, Mangham DC, Xu L, Yeste-Velasco M, Fisher G, North B, Chaplin T, Young B, Wang Y, Kaur Bansal J, Kudahetti S, Spencer L, Foster CS, Moller H, Scardino P, Oliver RT, Shamash J, Cuzick J, Cooper CS, Berney DM, Lu YJ. Identification of FBXL4 as a Metastasis Associated Gene in Prostate Cancer. Sci Rep. 2017 Jul 11;7(1):5124. doi: 10.1038/s41598-017-05209-z.
PubMed 28698647Berney DM, Beltran L, Fisher G, North BV, Greenberg D, Moller H, Soosay G, Scardino P, Cuzick J. Validation of a contemporary prostate cancer grading system using prostate cancer death as outcome. Br J Cancer. 2016 May 10;114(10):1078-83. doi: 10.1038/bjc.2016.86. Epub 2016 Apr 21.
PubMed 27100731Ahmad AS, Vasiljevic N, Carter P, Berney DM, Moller H, Foster CS, Cuzick J, Lorincz AT. A novel DNA methylation score accurately predicts death from prostate cancer in men with low to intermediate clinical risk factors. Oncotarget. 2016 Nov 1;7(44):71833-71840. doi: 10.18632/oncotarget.12377.
PubMed 27708246Cuzick J, Stone S, Fisher G, Yang ZH, North BV, Berney DM, Beltran L, Greenberg D, Moller H, Reid JE, Gutin A, Lanchbury JS, Brawer M, Scardino P. Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort. Br J Cancer. 2015 Jul 28;113(3):382-9. doi: 10.1038/bjc.2015.223. Epub 2015 Jun 23.
PubMed 26103570Vasiljevic N, Ahmad AS, Thorat MA, Fisher G, Berney DM, Moller H, Foster CS, Cuzick J, Lorincz AT. DNA methylation gene-based models indicating independent poor outcome in prostate cancer. BMC Cancer. 2014 Sep 6;14:655. doi: 10.1186/1471-2407-14-655.
PubMed 25193387Vasiljevic N, Ahmad AS, Carter PD, Fisher G, Berney DM, Foster CS, Cuzick J, Lorincz AT. DNA methylation of PITX2 predicts poor survival in men with prostate cancer. Biomark Med. 2014;8(9):1143-50. doi: 10.2217/bmm.14.41.
PubMed 25402584Merson S, Yang ZH, Brewer D, Olmos D, Eichholz A, McCarthy F, Fisher G, Kovacs G, Berney DM, Foster CS, Moller H, Scardino P, Cuzick J, Cooper CS, Clark JP; Transatlantic Prostate Group. Focal amplification of the androgen receptor gene in hormone-naive human prostate cancer. Br J Cancer. 2014 Mar 18;110(6):1655-62. doi: 10.1038/bjc.2014.13. Epub 2014 Jan 30.
PubMed 24481405Vasiljevic N, Ahmad AS, Beesley C, Thorat MA, Fisher G, Berney DM, Moller H, Yu Y, Lu YJ, Cuzick J, Foster CS, Lorincz AT. Association between DNA methylation of HSPB1 and death in low Gleason score prostate cancer. Prostate Cancer Prostatic Dis. 2013 Mar;16(1):35-40. doi: 10.1038/pcan.2012.47. Epub 2012 Nov 20.
PubMed 23165430Fisher G, Yang ZH, Kudahetti S, Moller H, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Prognostic value of Ki-67 for prostate cancer death in a conservatively managed cohort. Br J Cancer. 2013 Feb 5;108(2):271-7. doi: 10.1038/bjc.2012.598. Epub 2013 Jan 17.
PubMed 23329234Cuzick J, Yang ZH, Fisher G, Tikishvili E, Stone S, Lanchbury JS, Camacho N, Merson S, Brewer D, Cooper CS, Clark J, Berney DM, Moller H, Scardino P, Sangale Z; Transatlantic Prostate Group. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013 Jun 25;108(12):2582-9. doi: 10.1038/bjc.2013.248. Epub 2013 May 21.
PubMed 23695019Ahmad I, Singh LB, Yang ZH, Kalna G, Fleming J, Fisher G, Cooper C, Cuzick J, Berney DM, Moller H, Scardino P, Leung HY. Mir143 expression inversely correlates with nuclear ERK5 immunoreactivity in clinical prostate cancer. Br J Cancer. 2013 Jan 15;108(1):149-54. doi: 10.1038/bjc.2012.510.
PubMed 23321517Jeetle SS, Fisher G, Yang ZH, Stankiewicz E, Moller H, Cooper CS, Cuzick J, Berney DM; Trans-Atlantic Prostate Group. Neuroendocrine differentiation does not have independent prognostic value in conservatively treated prostate cancer. Virchows Arch. 2012 Aug;461(2):103-7. doi: 10.1007/s00428-012-1259-2. Epub 2012 Jul 6.
PubMed 22767265Cuzick J, Berney DM, Fisher G, Mesher D, Moller H, Reid JE, Perry M, Park J, Younus A, Gutin A, Foster CS, Scardino P, Lanchbury JS, Stone S; Transatlantic Prostate Group. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 2012 Mar 13;106(6):1095-9. doi: 10.1038/bjc.2012.39. Epub 2012 Feb 23.
PubMed 22361632
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
- ClinicalTrials.gov ID
- NCT03912883
- Acronym / sponsor ID
- TAPG / 005937
- Conditions
- Prostate Cancer
- Keywords
- biomarkers, pathology, tissue, watchful waiting, active surveillance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,350 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 12 Oct 1999 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Apr 2019 (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.
The Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised prostate cancer.
Detailed description
In 1999, the TAPG group initiated the "Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting" study, referred to as the TAPG study. It is a retrospective population-based tissue sample study in men diagnosed with localised prostate cancer 1990-2006, inclusively. Initially the cohort comprised men diagnosed with prostate cancer with transurethral resection of the prostate (TURP) and needle biopsies 1990-1996, but was expanded from 2005 to include men diagnosed with prostate cancer 1990 - 2006. Data was collected from six regional cancer registries and eligibility was confirmed via hospital sites, which sent the relevant tissue samples to the TAPG Central Coordinating Office (CCO). Selection of eligible patients for the study completed in 2010. Since this year the TAPG CCO has been collecting cancer registration and mortality updates on the cohort members from regional cancer registries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 76 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective, exploratory cohort study and will be carried out in patients registered on UK regional cancer registry databases, as having been diagnosed with prostate cancer between 1990 and 2006, inclusive.
Key inclusion criteria (7 listed)
- Patients must be aged less than 76 years at the time of diagnosis
- Patients must have had a baseline serum PSA level measured before starting any treatment and within six months of diagnosis
- Patients must have been diagnosed between 1990 and 2006 with a clinically localized (clinical stage T1-T3, N0 or NX, MO or MX) prostate cancer, in the judgment of the treating physician
- The initial diagnostic biopsy sample must be available for review. Patients should have (but are not required to have) tissue blocks available for review.
- There must be no evidence of metastatic disease
Key exclusion criteria (4 listed)
- Patients older than 76 years at the time of diagnosis
- Patients who have not had a baseline serum PSA level measured before starting any treatment
- Patients who do not have the initial diagnosis biopsy sample for review
- Patients with evidence of metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-specific survival
Time frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
Time from date of inclusion until death from prostate cancer.
Overall survival
Time frame: From date of inclusion to date of death from any cause, assessed up to 30 years.
Time from date of inclusion until death from any cause.
6 secondary outcomes
To evaluate a correlation between serum PSA level and prostate cancer-specific survival.
Time frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate a correlation between Gleason score and prostate cancer-specific survival.
Time frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate an association between clinical stage and prostate cancer-specific survival.
Time frame: From date of inclusion to date of death from any cause, assessed up to 30 years.
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
Time frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
Time frame: From date of inclusion to date of death from any cause, assessed up to 30 years.
To evaluate ERG-ETV1 biomarker predictors of prognosis in early prostate cancer.
Time frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 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 18 Nov 2025.
- Background: PubMed 30531531Beltran L, Ahmad AS, Sandu H, Kudahetti S, Soosay G, Moller H, Cuzick J, Berney DM; Transatlantic Prostate Group. Histopathologic False-positive Diagnoses of Prostate Cancer in the Age of Immunohistochemistry. Am J Surg Pathol. 2019 Mar;43(3):361-368. doi: 10.1097/PAS.0000000000001202.
- Background: PubMed 29755671Ahmad AS, Parameshwaran V, Beltran L, Fisher G, North BV, Greenberg D, Soosay G, Moller H, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Should reporting of peri-neural invasion and extra prostatic extension be mandatory in prostate cancer biopsies? correlation with outcome in biopsy cases treated conservatively. Oncotarget. 2018 Apr 17;9(29):20555-20562. doi: 10.18632/oncotarget.24994. eCollection 2018 Apr 17.
- Background: PubMed 28698647Stankiewicz E, Mao X, Mangham DC, Xu L, Yeste-Velasco M, Fisher G, North B, Chaplin T, Young B, Wang Y, Kaur Bansal J, Kudahetti S, Spencer L, Foster CS, Moller H, Scardino P, Oliver RT, Shamash J, Cuzick J, Cooper CS, Berney DM, Lu YJ. Identification of FBXL4 as a Metastasis Associated Gene in Prostate Cancer. Sci Rep. 2017 Jul 11;7(1):5124. doi: 10.1038/s41598-017-05209-z.
- Background: PubMed 27100731Berney DM, Beltran L, Fisher G, North BV, Greenberg D, Moller H, Soosay G, Scardino P, Cuzick J. Validation of a contemporary prostate cancer grading system using prostate cancer death as outcome. Br J Cancer. 2016 May 10;114(10):1078-83. doi: 10.1038/bjc.2016.86. Epub 2016 Apr 21.
- Background: PubMed 27708246Ahmad AS, Vasiljevic N, Carter P, Berney DM, Moller H, Foster CS, Cuzick J, Lorincz AT. A novel DNA methylation score accurately predicts death from prostate cancer in men with low to intermediate clinical risk factors. Oncotarget. 2016 Nov 1;7(44):71833-71840. doi: 10.18632/oncotarget.12377.
- Background: PubMed 26103570Cuzick J, Stone S, Fisher G, Yang ZH, North BV, Berney DM, Beltran L, Greenberg D, Moller H, Reid JE, Gutin A, Lanchbury JS, Brawer M, Scardino P. Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort. Br J Cancer. 2015 Jul 28;113(3):382-9. doi: 10.1038/bjc.2015.223. Epub 2015 Jun 23.
- Background: PubMed 25193387Vasiljevic N, Ahmad AS, Thorat MA, Fisher G, Berney DM, Moller H, Foster CS, Cuzick J, Lorincz AT. DNA methylation gene-based models indicating independent poor outcome in prostate cancer. BMC Cancer. 2014 Sep 6;14:655. doi: 10.1186/1471-2407-14-655.
- Background: PubMed 25402584Vasiljevic N, Ahmad AS, Carter PD, Fisher G, Berney DM, Foster CS, Cuzick J, Lorincz AT. DNA methylation of PITX2 predicts poor survival in men with prostate cancer. Biomark Med. 2014;8(9):1143-50. doi: 10.2217/bmm.14.41.
- Background: PubMed 24481405Merson S, Yang ZH, Brewer D, Olmos D, Eichholz A, McCarthy F, Fisher G, Kovacs G, Berney DM, Foster CS, Moller H, Scardino P, Cuzick J, Cooper CS, Clark JP; Transatlantic Prostate Group. Focal amplification of the androgen receptor gene in hormone-naive human prostate cancer. Br J Cancer. 2014 Mar 18;110(6):1655-62. doi: 10.1038/bjc.2014.13. Epub 2014 Jan 30.
- Background: PubMed 23165430Vasiljevic N, Ahmad AS, Beesley C, Thorat MA, Fisher G, Berney DM, Moller H, Yu Y, Lu YJ, Cuzick J, Foster CS, Lorincz AT. Association between DNA methylation of HSPB1 and death in low Gleason score prostate cancer. Prostate Cancer Prostatic Dis. 2013 Mar;16(1):35-40. doi: 10.1038/pcan.2012.47. Epub 2012 Nov 20.
- Background: PubMed 23329234Fisher G, Yang ZH, Kudahetti S, Moller H, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Prognostic value of Ki-67 for prostate cancer death in a conservatively managed cohort. Br J Cancer. 2013 Feb 5;108(2):271-7. doi: 10.1038/bjc.2012.598. Epub 2013 Jan 17.
- Background: PubMed 23695019Cuzick J, Yang ZH, Fisher G, Tikishvili E, Stone S, Lanchbury JS, Camacho N, Merson S, Brewer D, Cooper CS, Clark J, Berney DM, Moller H, Scardino P, Sangale Z; Transatlantic Prostate Group. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013 Jun 25;108(12):2582-9. doi: 10.1038/bjc.2013.248. Epub 2013 May 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Queen Mary University of London.
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 7 inclusion and 4 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Disease-specific survival (time frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.). The study lists 2 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 NCT03912883, which also lists 37 linked publications.
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 18 Nov 2025.