Prostate cancer treatment patterns and outcomes by ethnicity: a national cohort study using routinely collected data

Queen Mary University of London (QMUL) and University College London (UCL) requires access to NHS England data for the purpose of the following research project:

Prostate cancer treatment patterns and outcomes by ethnicity: a national cohort study using routinely collected data

The following is a summary of the aims of the research project provided by QMUL and UCL

1. To describe demographics, tumour characteristics and treatment types by ethnic group

2. To determine whether ethnicity is associated with survival in men with prostate cancer and to perform a sub-analysis examining survival by ethnicity in men with metastatic Castration-Resistant Prostate Cancer (mCRPC)

3. To determine whether prostate cancer treatment patterns differ by ethnicity, including

a) uptake of first treatment (surgery, radiotherapy or chemotherapy) following diagnosis and

b) uptake of treatment intensification for metastatic Hormone Sensitive Prostate Cancer (mHSPC)

The following NHS England Data will be accessed:

• NDRS Cancer Consolidated Dataset- necessary to identify patients diagnosed with prostate cancer, as well as comorbidities, treatments and define specific groups of patients e.g. mCRPC for pre-specified analyses

The level of the Data will:

• Pseudonymised

The Data will be minimised for each use in the following ways:

- All cancer conditions will be included for any man diagnosed with prostate cancer (ICD-10 code: C61 ‘malignant neoplasm of prostate’) in England between 2013 and 2022.

Exclusions (to be applied by QMUL when analysing the data in the SDE)

• Prostate cancer diagnosis made after death (post-mortem)

• Men with a previous diagnosis of any cancer (except non-melanoma skin cancer) recorded in the cancer registry

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The legal basis for processing special category data under UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This research aims is in the public interest as it could help direct targeted strategies aimed at addressing inequalities and improving treatment uptake, adherence and patient outcomes (including survival) in men with prostate cancer in the UK and internationally.

or care.

The funding is provided by UCL School of Pharmacy, Research Department of Practice and Policy. The funding is specifically for the study described.

Additional funding by the Wellcome Trust is in place until 17/09/2027 to fund a PhD student at QMUL, who will process data as part of a doctoral research.

The funders will have no ability to suppress or otherwise limit the publication of findings.

Data will be accessed by an enrolled PhD student and a QMUL research team (a Senior Clinical Lecturer in cancer research and a professor of biostatistics), who are employed by QMUL. The individuals have completed mandatory data protection and confidentiality training and is subject to QMUL’s policies on data protection and confidentiality. The individuals accessing the data will do so under the supervision of a substantive employee of QMUL and would be responsible and liable for any work carried out by the individuals. The individuals would only work on the data for the purposes described in this Data Sharing Agreement (DSA).

An ethnically diverse PPIE panel has been involved in the development of this project. The PPIE panel comprises of men (currently 5) who have prostate cancer / a history of prostate cancer. The PPIE members were involved in the development of the TRANSFORM funding application and the project. The applicant will continue to engage with them regularly during the project, sharing results as they emerge and discussing potential implications. Their role within the project is an advisory role only. They strongly support this Project.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry-leading analytics tools.

NHS England will provide access to the relevant records from the NDRS Cancer Consolidated dataset dataset via NHS England Secure Data Environment (SDE). The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable, and all users must comply with the use of the Data as specified in this DSA.

Users are only authorised to access the Data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

The Data will be stored on servers at NHS England.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England.

Access is restricted to employees or agents of Queen Mary University of London who have authorisation from Senior Clinical Lecturer in cancer research.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the Data.

The PhD student and the Queen Mary University of London research team will process and analyse the Data for the purposes described above.

Anticipated outputs align with the stated objectives of this project:

1) A minimum of two peer reviewed journal articles are anticipated reporting: a) prostate cancer survival by ethnic group in England and b) treatment patterns and uptake by ethnic group in England. The applicant anticipates submitting the first paper, on survival within 18 months of data delivery and the second within 36 months. Papers will only be published in open access journals. The applicant plans to include annotated code (e.g. stata code) for statistical analyses, to enable replication of the work and to facilitate adaption so it can be used for other cancers or in other countries/settings.

2) Conference presentations: The applicant anticipates presenting results at national and international conferences targeted at clinicians, researchers and policy makers e.g. ASCO. They plan to present at a minimum of three conferences during the study during 2024, 2025 and 2026.

3) PhD thesis: Findings may be reported in a PhD thesis which will be made publicly available via the QMUL repository on PhD completion (2027).

4) Press releases will be prepared by the QMUL press office to coincide with publication/presentation of key results.

5) The applicant will engage with prostate cancer charities and patient advocacy groups (who are already engaged within the wider programme) throughout the project. These groups will help disseminate key findings to lay audiences.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

This research is specifically designed to determine whether ethnic disparities exist in prostate cancer treatment patterns and survival in the England and to help identify potential contributing factors.

This research is of patient benefit as an understanding of whether disparities exist, what groups they affect and key factors contributing to those disparities, will enable the development of interventions to improve patient care and outcomes e.g. interventions aimed at improving adoption of certain treatments in specific ethnic groups if disparities are identified.

The research could inform national guidelines and policy, for example if the applicant identifies particular benefit from certain treatments in specific groups. To ensure that this research leads to maximum patient benefit, they will disseminate findings to researchers and policy makers (through academic publications and conference presentations) to the general public (through press releases from the QMUL press office and via social media) and to patients and advocacy groups (through engagement with the PPIE panel and Prostate cancer Research).

Importantly, the TRANSFORM PPIE panel will provide input when considering the findings and how they could be used to maximise patient benefit.

Yielded Benefits is not a requirement for new applications.