Prostate CancerMIND-PNCT04647474
Mental Wellbeing and Quality of Life in Prostate Cancer
An observational study of Prostate Cancer, run by King's College London at 7 sites in United Kingdom.
Trial summary
The complex relationship that exists between physical and mental health in prostate cancer is increasingly being understood. Psychiatric symptoms are common in this group and have important consequences for the quality of life and cancer outcomes for patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 15 Jan 2021to 29 Mar 2023
- Phase
- Observational
- 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
Study population: The population of study are patients with a recently newly confirmed diagnosis, or clinically likely diagnosis of prostate cancer in a secondary care setting. Four separate sub-cohorts based on treatment or management allocated will be recruited with identical inclusion and exclusion criteria, with the exception of treatment specific characteristics. The four cohorts to be recruited will be newly diagnosed men with prostate are those described in the eligibility criteria.
Who may be able to join
- New diagnosis of histologically proven or clinically likely prostate cancer
- No limits on grade, histology type or risk stratification classification
- Post Multi Disciplinary Team discussion with allocation of a suggested treatment or follow up strategy
- Undergoing one of the following four treatment/management options:
- Radical Prostatectomy
- Radiotherapy (External beam radiation therapy or brachytherapy)
Show all 9Show fewer
- Active Surveillance
- Androgen Deprivation Therapy (Medical or Surgical castration)
- Follow up undertaken by urology, oncology or mixed uro-oncology teams
Who cannot join
- Patient is pre-Multi Disciplinary Team discussion
- Patient has already undergone the allocate intervention
- Post-surgery
- Post first radiotherapy dose
- Attended second active surveillance follow up
- Received >1 dose (initial dose) of Gonadotropin-releasing hormone agonist/antagonist
Show all 17Show fewer
- Patients receiving the following therapies:
- Palliative patients on symptom control only
- Patients allocated to watchful waiting
- Any type of Focal therapy e.g. high intensity focused ultrasound (HIFU)
- Patients receiving adjuvant combination therapy e.g. Androgen deprivation therapy or chemotherapy pre radiotherapy or surgery
- Metastatic patients undergoing chemotherapy alone
- Patients presenting with recurrence or progression of prostate cancer
- Concurrent management for another cancer diagnosis
- Recent admission to an inpatient psychiatric facility within the previous 12 months prior to diagnosis of prostate cancer
- Patients lacking capacity to consent or undertake in the research
- Those unable to complete the required surveys, such as those not able to understand English or those with severe learning disability
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Bedfordshire Hospitals NHS Foundation Trust
Bedford, Bedfordshire, MK42 9DJ
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 9RS
Lewisham and Greenwich NHS Trust
London, Greater London, SE18 4QH
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 9RS
Imperial College Healthcare NHS Trust
London, Greater London, W2 1NY
Surrey and Sussex Healthcare NHS Trust
Redhill, Surrey, RH1 5RH
About this study
Official title: A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study
The complex relationship that exists between physical and mental health in prostate cancer is increasingly being understood. Psychiatric symptoms are common in this group and have important consequences for the quality of life and cancer outcomes for patients with prostate cancer. However, less is understood about the severity of disease and which patient factors and treatment options are risk factors for developing problems. Additionally, the impact these conditions have on problems such as urinary incontinence or sexual function is less well understood. The investigators anticipate that different patient characteristics and treatment options increase an individuals risk of developing problems after a prostate cancer diagnosis. Therefore, this study aims to further investigate these specific factors to improve follow up care in patients with prostate cancer.
This observational study will follow up newly diagnosed prostate cancer patients for a period of 12 months to evaluate these outcomes. Participants will be identified across seven hospitals in London and South England. After being recruited participants will be invited to undergo repeated online or postal questionnaires at baseline, 3, 6, 9 and 12 months. These will assess depressive and anxiety symptom load, body image issues, fear of recurrence, masculinity perception and functional symptoms (including urinary, bowel and sexual symptoms) load.
Analysis of these findings will allow for identification of 1) Which subgroups of patients appear to have worse mental wellbeing and quality of life outcomes, and 2) How mental health issues impact functional outcomes. This will provide important information for guiding future research within the subject area and further inform clinicians about these issues.
Read the detailed description
Prostate cancer represents a large proportion of global cancer incidence, accounting for 13.5% of all male cancers. However, with high survival rates, which are still improving, there is growing acceptance that living longer does not always equate to living well. The mental health aspect of the disease is unfortunately sometimes neglected with research focusing on the physical symptoms after disease much more prominent and frequently conducted. Previous research has already demonstrated that mental health issues are common in patient with prostate cancer, however, less is known about which patients are at greater risk of developing problems after being diagnosed with prostate cancer. Additionally, the association between mental health conditions and what are called 'functional outcomes' (i.e. bladder, bowel and sexual function) after treatment are less well understood. A greater knowledge of these factors can help clinicians to make better assessments of patients and also will help the future development of additional tools which are able to help with diagnosis in future.
With these factors in mind the primary aims of the research study is :
- To evaluate the association between prostate cancer patients undergoing different treatments and overall mental wellbeing in the initial cancer follow-up stage.
The secondary aims of the study are to:
- Identify high risk time-frames post diagnosis for worsening of mental wellbeing
- Assess the impact of depressive and anxiety symptoms on functional, clinical and other mental wellbeing outcomes.
- Explore patient and cancer related factors conferring a risk for the development of significant mental wellbeing problems.
The investigators hypothesis is that prostate cancer patients experience a high psychological symptom load in the initial follow up period after diagnosis. Additionally, based on previous prostate cancer and mental health research the investigators hypothesise that certain subgroups (e.g. certain treatment or patient groups) are at increased risk of developing significant psychological symptoms.
To explore these aims and hypothesis the investigators will conduct a questionnaire based, longitudinal and observational cohort study of participants recently diagnosed with prostate cancer. There is no interventional element to the study. The investigators will identify newly diagnosed patients, who have not yet received treatment from multiple hospital sites in London and the South East of England. This will include patients allocated to surgery, radiotherapy, surveillance or hormone therapy depending on prostate cancer characteristics. Participants will be identified by the clinical team during the hospital outpatient appointment, with contact details taken at this stage. The investigators are aiming to recruit 300 participants for this study based on power calculations (80% power with 0.05 significance) for the primary outcomes taking into account a maximum drop out rate of 25%.
Following identification, screening and consenting for inclusion into the study participants will begin data collection through serial questionnaires. Participants will have the option of either undergoing postal or electronic follow up, depending on preference. Questionnaires will include numerous validated measures to evaluate mental and social wellbeing as well as functional symptoms of disease/treatment including bladder, bowel and sexual function as per the outcome measures described.
Collection of data will occur at set intervals for the duration of the study and will include the same questionnaire being filled at the beginning of the study, 3, 6, 9 and 12 months. Additionally, at the outset of the study some further information will be asked from the participant including demographics and previous medical or psychiatric history. The research team will in addition collect data from the medical files at the beginning of the study about the cancer characteristics and then again at the end of the study at 12 months. At 12 months participants will complete the study and data analysis along the primary and secondary outcome measures will be conducted once all participants have completed this.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Depression, Anxiety, Mental Wellbeing, Functional Outcomes, Social Wellbeing
- Medical subject headings
- Prostatic Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radical Prostatectomy | Participants undergoing any curative surgical treatment option for prostate cancer irregardless of approach (open, laparoscopic or robotic) | |
| Active Surveillance | Participants undergoing active surveillance as the management option for prostate cancer as defined by regular surveillance attendance at the primary treating site. | |
| Hormone Monotherapy | Participants undergoing medical hormone therapy (Antiandrogens and Gonadotropin-releasing hormone (GnRH) agonists or antagonists) or surgical castration (e.g. orchidectomy) options as the primary treatment for prostate cancer. | |
| Radical Radiotherapy | Participants undergoing primary radiotherapy treatment for prostate cancer irregardless of delivery methods (e.g. External beam radiation therapy or brachytherapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of mental wellbeing measures between four management groups
Mental wellbeing validated tools scores including Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Body Image Scale, Fear of Recurrence Scale and Masculine Self-Esteem Prostate Cancer-Related Quality of Life (PC-QOL) Subset Scale
Measured: Baseline, 3, 6, 9 and 12 months post diagnosis
Secondary outcomes (4)
Cumulative incidence of significant mental wellbeing outcomes
Binary outcome of the development of significant individual mental wellbeing outcomes (depression, anxiety, body image issues, masculinity and fear of cancer recurrence)
Measured: 12 Months
Exploration of prognostic factors of mental wellbeing outcomes.
Pre-selected patient, oncological and treatment factors evaluated against each individual mental wellbeing outcome for exploration of potentially prognostic factors for significant symptom development.
Measured: Within 12 months of diagnosis
Relationship between each individual mental wellbeing symptom and functional/social wellbeing.
Functional outcomes will include sexual, urinary and bowel symptoms from EPIC-26. Social wellbeing will include FACT-G subscale scores with general health defined using the SF-12 physical component score.
Measured: At 12 months post diagnosis.
Evaluation of effect of time on symptoms
Evaluate the trajectory of mental wellbeing symptoms over a 12-month period and effect of time on symptom scores.
Measured: Within 12 months of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start15 Jan 2021
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 King's College 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Imperial College Healthcare NHS Trust, Medway NHS Foundation Trust, Lewisham and Greenwich NHS Trust, Surrey and Sussex Healthcare NHS Trust, Bedfordshire Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Kamran Ahmed, MBBS, FRCS, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647474
- Sponsor's protocol ID
- 284473
- Acronym
- MIND-P
- Status last verified
- May 2023
- First submitted
- 23 Nov 2020
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data pertaining to any analysis conducted by this research will be made available publicly without restriction after the conductance of the study through the King's Research Data Repository.
Publications
Brunckhorst O, Liszka J, James C, Fanshawe JB, Hammadeh M, Thomas R, Khan S, Sheriff M, Muir G, Ahmed HU, Van Hemelrijck M, Stewart R, Dasgupta P, Ahmed K. Mental well-being in prostate cancer: A multi-institutional prospective cohort study. BJUI Compass. 2025 Jun 17;6(6):e70040. doi: 10.1002/bco2.70040. eCollection 2025 Jun.
PubMed 40528942Brunckhorst O, Liszka J, James C, Fanshawe JB, Hammadeh M, Thomas R, Khan S, Sheriff M, Ahmed HU, Van Hemelrijck M, Muir G, Stewart R, Dasgupta P, Ahmed K. Mental wellbeing and quality of life in prostate cancer (MIND-P): Protocol for a multi-institutional prospective cohort study. PLoS One. 2023 Apr 24;18(4):e0284727. doi: 10.1371/journal.pone.0284727. eCollection 2023.
PubMed 37093833
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study
- ClinicalTrials.gov ID
- NCT04647474
- Acronym / sponsor ID
- MIND-P / 284473
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Depression, Anxiety, Mental Wellbeing, Functional Outcomes, Social Wellbeing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Imperial College Healthcare NHS Trust, Medway NHS Foundation Trust, Lewisham and Greenwich NHS Trust, Surrey and Sussex Healthcare NHS Trust, Bedfordshire Hospitals NHS Foundation Trust
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 1 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.
The complex relationship that exists between physical and mental health in prostate cancer is increasingly being understood. Psychiatric symptoms are common in this group and have important consequences for the quality of life and cancer outcomes for patients with prostate cancer. However, less is understood about the severity of disease and which patient factors and treatment options are risk factors for developing problems. Additionally, the impact these conditions have on problems such as urinary incontinence or sexual function is less well understood. The investigators anticipate that different patient characteristics and treatment options increase an individuals risk of developing problems after a prostate cancer diagnosis. Therefore, this study aims to further investigate these specific factors to improve follow up care in patients with prostate cancer.
This observational study will follow up newly diagnosed prostate cancer patients for a period of 12 months to evaluate these outcomes. Participants will be identified across seven hospitals in London and South England. After being recruited participants will be invited to undergo repeated online or postal questionnaires at baseline, 3, 6, 9 and 12 months. These will assess depressive and anxiety symptom load, body image issues, fear of recurrence, masculinity perception and functional symptoms (including urinary, bowel and sexual symptoms) load.
Analysis of these findings will allow for identification of 1) Which subgroups of patients appear to have worse mental wellbeing and quality of life outcomes, and 2) How mental health issues impact functional outcomes. This will provide important information for guiding future research within the subject area and further inform clinicians about these issues.
Detailed description
Prostate cancer represents a large proportion of global cancer incidence, accounting for 13.5% of all male cancers. However, with high survival rates, which are still improving, there is growing acceptance that living longer does not always equate to living well. The mental health aspect of the disease is unfortunately sometimes neglected with research focusing on the physical symptoms after disease much more prominent and frequently conducted. Previous research has already demonstrated that mental health issues are common in patient with prostate cancer, however, less is known about which patients are at greater risk of developing problems after being diagnosed with prostate cancer. Additionally, the association between mental health conditions and what are called 'functional outcomes' (i.e. bladder, bowel and sexual function) after treatment are less well understood. A greater knowledge of these factors can help clinicians to make better assessments of patients and also will help the future development of additional tools which are able to help with diagnosis in future.
With these factors in mind the primary aims of the research study is :
- To evaluate the association between prostate cancer patients undergoing different treatments and overall mental wellbeing in the initial cancer follow-up stage.
The secondary aims of the study are to:
- Identify high risk time-frames post diagnosis for worsening of mental wellbeing
- Assess the impact of depressive and anxiety symptoms on functional, clinical and other mental wellbeing outcomes.
- Explore patient and cancer related factors conferring a risk for the development of significant mental wellbeing problems.
The investigators hypothesis is that prostate cancer patients experience a high psychological symptom load in the initial follow up period after diagnosis. Additionally, based on previous prostate cancer and mental health research the investigators hypothesise that certain subgroups (e.g. certain treatment or patient groups) are at increased risk of developing significant psychological symptoms.
To explore these aims and hypothesis the investigators will conduct a questionnaire based, longitudinal and observational cohort study of participants recently diagnosed with prostate cancer. There is no interventional element to the study. The investigators will identify newly diagnosed patients, who have not yet received treatment from multiple hospital sites in London and the South East of England. This will include patients allocated to surgery, radiotherapy, surveillance or hormone therapy depending on prostate cancer characteristics. Participants will be identified by the clinical team during the hospital outpatient appointment, with contact details taken at this stage. The investigators are aiming to recruit 300 participants for this study based on power calculations (80% power with 0.05 significance) for the primary outcomes taking into account a maximum drop out rate of 25%.
Following identification, screening and consenting for inclusion into the study participants will begin data collection through serial questionnaires. Participants will have the option of either undergoing postal or electronic follow up, depending on preference. Questionnaires will include numerous validated measures to evaluate mental and social wellbeing as well as functional symptoms of disease/treatment including bladder, bowel and sexual function as per the outcome measures described.
Collection of data will occur at set intervals for the duration of the study and will include the same questionnaire being filled at the beginning of the study, 3, 6, 9 and 12 months. Additionally, at the outset of the study some further information will be asked from the participant including demographics and previous medical or psychiatric history. The research team will in addition collect data from the medical files at the beginning of the study about the cancer characteristics and then again at the end of the study at 12 months. At 12 months participants will complete the study and data analysis along the primary and secondary outcome measures will be conducted once all participants have completed this.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Radical Prostatectomy | – | –Participants undergoing any curative surgical treatment option for prostate cancer irregardless of approach (open, laparoscopic or robotic) |
| Active Surveillance | – | –Participants undergoing active surveillance as the management option for prostate cancer as defined by regular surveillance attendance at the primary treating site. |
| Hormone Monotherapy | – | –Participants undergoing medical hormone therapy (Antiandrogens and Gonadotropin-releasing hormone (GnRH) agonists or antagonists) or surgical castration (e.g. orchidectomy) options as the primary treatment for prostate cancer. |
| Radical Radiotherapy | – | –Participants undergoing primary radiotherapy treatment for prostate cancer irregardless of delivery methods (e.g. External beam radiation therapy or brachytherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of study are patients with a recently newly confirmed diagnosis, or clinically likely diagnosis of prostate cancer in a secondary care setting. Four separate sub-cohorts based on treatment or management allocated will be recruited with identical inclusion and exclusion criteria, with the exception of treatment specific characteristics. The four cohorts to be recruited will be newly diagnosed men with prostate are those described in the eligibility criteria.
Key inclusion criteria (9 listed)
- New diagnosis of histologically proven or clinically likely prostate cancer
- Post Multi Disciplinary Team discussion with allocation of a suggested treatment or follow up strategy
- Undergoing one of the following four treatment/management options:
- Follow up undertaken by urology, oncology or mixed uro-oncology teams
Key exclusion criteria (17 listed)
- Patient is pre-Multi Disciplinary Team discussion
- Patient has already undergone the allocate intervention
- Patients receiving the following therapies:
- Patients presenting with recurrence or progression of prostate cancer
- Concurrent management for another cancer diagnosis
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
Mean difference of mental wellbeing measures between four management groups
Time frame: Baseline, 3, 6, 9 and 12 months post diagnosis
Mental wellbeing validated tools scores including Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Body Image Scale, Fear of Recurrence Scale and Masculine Self-Esteem Prostate Cancer-Related Quality of Life (PC-QOL) Subset Scale
4 secondary outcomes
Cumulative incidence of significant mental wellbeing outcomes
Time frame: 12 Months
Exploration of prognostic factors of mental wellbeing outcomes.
Time frame: Within 12 months of diagnosis
Relationship between each individual mental wellbeing symptom and functional/social wellbeing.
Time frame: At 12 months post diagnosis.
Evaluation of effect of time on symptoms
Time frame: Within 12 months of diagnosis
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 May 2023.
- Derived from this study: PubMed 40528942Brunckhorst O, Liszka J, James C, Fanshawe JB, Hammadeh M, Thomas R, Khan S, Sheriff M, Muir G, Ahmed HU, Van Hemelrijck M, Stewart R, Dasgupta P, Ahmed K. Mental well-being in prostate cancer: A multi-institutional prospective cohort study. BJUI Compass. 2025 Jun 17;6(6):e70040. doi: 10.1002/bco2.70040. eCollection 2025 Jun.
- Derived from this study: PubMed 37093833Brunckhorst O, Liszka J, James C, Fanshawe JB, Hammadeh M, Thomas R, Khan S, Sheriff M, Ahmed HU, Van Hemelrijck M, Muir G, Stewart R, Dasgupta P, Ahmed K. Mental wellbeing and quality of life in prostate cancer (MIND-P): Protocol for a multi-institutional prospective cohort study. PLoS One. 2023 Apr 24;18(4):e0284727. doi: 10.1371/journal.pone.0284727. eCollection 2023.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data pertaining to any analysis conducted by this research will be made available publicly without restriction after the conductance of the study through the King's Research Data Repository.
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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.
Kamran Ahmed, MBBS, FRCS principal investigator
King's College London
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by King's College London at 7 sites in United Kingdom.
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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. 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?
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?
Mean difference of mental wellbeing measures between four management groups (time frame: Baseline, 3, 6, 9 and 12 months post diagnosis). 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 NCT04647474, which also lists 2 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 26 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.