UK Genetic Prostate Cancer Study (consent)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[10 paragraphs unchanged] • Limited to a study cohort identified by ICR –10,604 (aprx) consented participants (covered under DSA (DARS-NIC-148118) and 8,720 (aprx) covered by Section 251. 251 and Consultee Advice (covered under DSA DARS-NIC-790414) • Limited to data between the participant’s inclusion into the study until 2026. 2026 [28 paragraphs unchanged]

Unchanged: Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: − Cancer Registration Data; − Demographics

Objective for processing

Under this Data Sharing Agreement, the Institute of Cancer Research (ICR) is permitted to retain data that was supplied under previous iterations of this DSA. The DSA does not permit any other processing of the data. The Institute of Cancer Research (ICR) requires access to NHS England data for the purpose of the following research project: The UK Genetic Prostate Cancer Study (UKGPC) The data was originally supplied to the ICR under a Data Sharing Agreement with the ICR and the Royal Marsden NHS Foundation Trust for the purpose of the UK Genetic Prostate Cancer Study (UKGPCS). The UKGPCS was first established in 1992 and is the largest prostate cancer study of its kind in the UK, involving nearly 200 hospitals. The following is a summary of the aims of the research project provided ICR: The study recruited patients who gave consent to participate in the study. Identifying details of consented participants were provided to NHS Digital (or predecessor organisations) for linkage. Notifications of participant deaths (date and cause of death), cancer registrations and Demographics data (NHS number, Forenames/Surname, latest patient registration) were provided back to the ICR for the purpose of the study. NHS England currently holds the details of 19,324 study participants. “The study aims to find genetic changes which are associated with prostate cancer risk. If the study can find alterations in genes that increase the chances of getting prostate cancer, it may be possible in the future to use this knowledge: By 2021, the study had recruited over 22,500 participants and aimed to recruit 26,000 by the end of 2022. Each consented patient gives a blood/saliva sample, and a family history questionnaire, and The Institute of Cancer Research (ICR) obtain clinical data from their referring hospital or consultant. • To screen other family members to see if they are also at a higher risk of developing prostate cancer, The study aims to find genetic changes which are associated with prostate cancer risk. If the study can find alterations in genes that increase the chances of getting prostate cancer, it may be possible in the future to use this knowledge: • To develop new prostate cancer treatments for the future.” o To screen other family members to see if they are also at a higher risk of developing prostate cancer, The following NHS England data will be accessed: o To develop new prostate cancer treatments for the future. • Civil Registration Mortality– necessary when assessing the survival analysis. The ICR’s legal basis for processing this information is for the performance of a task carried out in the public interest Article 6 (1) (e). The ICR processes sensitive health and genetic information for the purposes of scientific research with appropriate safeguards in place to protect personal information, (Article 9 (2) (j), as required by the EU General Data Protection Regulation. The level of the data will be: Identifiable. • Identifiable – necessary because although the applicant will pseudonymise the data before analysis, reidentifying is required to enable linkage of the data with data collected from other sources such as clinical data of consented participants from the referring hospital or consultant that has been shared with ICR. The data will be minimised as follows. • Limited to a study cohort identified by ICR –10,604 consented participants and 8,720 covered by Section 251. • Limited to data between the participant’s inclusion into the study until 2026. [3 paragraphs unchanged] o They are a prostate cancer patient at the Royal Marsden NHS Foundation Trust. Trust (RMH) o They are taking part in the CyberKnife prostate SBRT studies. ICR is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above. NHS England has reviewed the patient information and consent forms used in recruitment and requires the ICR to provide further reassurance of a legal basis for processing confidential patient data for all study participants involved. The lawful basis for processing personal data under the UK GDPR is: NHS England requires the ICR to review the roles of the organisations involved in the study and to provide a clear explanation of which organisations are and are not data controllers as supported by the facts. 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; NHS England notes that the ICR has supplied "anonymised data from this to other studies under an MTA" (Material Transfer Agreement). NHS England requires clarification of whether any data covered by this Agreement has been shared with third parties and/or whether there is an intention to onwardly share data under this Agreement in the future subject to the necessary approvals. The lawful basis for processing special category data under the 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 processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The funding comes from multiple sources. Current funders include: • Cancer Research UK • NIH • NIHR • Prostate Cancer UK (formerly PCCT) • Prof. Eeles Research Fund • The ICR Everyman Campaign • Movember Funding to continue the work described will be sought on an ongoing basis. The funder(s) will have no ability to suppress or otherwise limit the publication of findings An optional questionnaire looking at Gene-Environment Interactions in Prostate Cancer as part of this study is conducted in collaboration with the University of Manchester (UoM). The leading professor at UoM holds an Honorary Contract with ICR. The professor’s team at UoM will be responsible for analysing and storing the data collected on this questionnaire – this does not include any data that is disseminated from NHS England. UoM does not obtain any data from NHS England (via ICR) but the epidemiological questionnaires via the participants (at RMH). So while UoM might have some authority over these questionnaires, the UoM does not for the data from NHS England under this Data Sharing Agreement. The data will therefore be accessed by: • Substantive employees of ICR • Individuals with honorary contracts with ICR The Institute of Cancer Research (ICR) work closely with a group of experienced public contributors in their research to review grants, protocols, and amendments and assist in the writing of /public-facing documents. Their support is invaluable in decision-making about The Institute of Cancer Research (ICR) research projects and they contribute to the following: a) Oversee all patient and public-facing information b) Identify & provide input to projects in respect of patient priorities and impact throughout the duration of the projects c) Help to frame research results and participate in dissemination and engagement across multiple channels and formats over and above academic output RMH works with >200 public contributors involved in various projects and their Cancer Patients’ Voice digital platform extends this reach to diverse and underserved groups nationally. RMH contributors benefit from a wide infrastructure for patient and public involvement, including an ‘onboarding’ process with dedicated training.

Processing activities

Under this Data Sharing Agreement, the Institute of Cancer Research (ICR) is permitted to retain data that was supplied under previous iterations of this DSA. The DSA does not permit any other processing of the data. ICR will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, forenames, surname, Date of Birth, Postcode, Sex, Study ID) for the cohort to be linked with NHS England data In order for the cohort to be linked the following identifiers were supplied to NHS England (*or predecessor organisations): NHS England data will provide the relevant records from the Civil Registrations Deaths datasets to ICR. The data will contain directly identifying data items including -Study ID, Cause of Death and Date of Death which are required to link the Data at record level with data already held by the recipient. o NHS Number The data will not be transferred to any other location. o Forenames The data will be stored on servers at ICR. o Surname The Data will be accessed by authorised personnel via remote access. o Date of Birth The Controller 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. o Sex For remote access: o Postcode - 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; o Study ID - Access controls granting users the minimum level of access required are in place; NHS England* returned the following data to the Institute of Cancer Research: - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; o Civil Registration Deaths - Multifactor authentication (MFA) is required for remote access; o Demographic Data: NHS number, Forenames/Surname, latest patient registration - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; o Cancer Data: Cancer registration number, type, and behaviour code of cancer. Cancer registry centre code, ICD10 site code as well as cancer anniversary year/month and day. - 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 ICR has not been authorised to onwardly share the data above. The above applies in addition to any condition set out elsewhere within the DSA. The data will be processed in England. Data will be accessed by individuals with an honorary contract with ICR. The individual(s) will act as an agent of ICR at all times under supervision from employees of ICR. Aside from these individuals, access is restricted to employees or agents of ICR who have authorisation from the Principal Investigator. All personnel accessing the data have been appropriately trained in data protection and confidentiality. The data will be linked to clinical data obtained from the consented participant’s referring hospital or consultant. There will be no requirement and no attempt to reidentify individuals when using the data. The Data Controller intends to create a dataset under this Data Sharing Agreement. The metadata associated with the dataset and other information as required will be submitted to NHS England. NHS England will then decide whether it may be categorised as Derived Data under the definition set out in the DSFC. The Data Controller is accountable for the Derived Data and must ensure it is only used for purposes as identified in this DSA. The definition of the Derived Data asset (e.g. fields contained within it) must not be amended without prior approval by NHS England.

Expected output

This Agreement permits the secure retention of the data only and no other processing. The expected outputs of the processing will be: No new outputs will be produced under this Data Sharing Agreement. • Submissions to peer-reviewed journals - All previous publications are listed on the UKGPCS website: www.icr.ac.uk/ukgpcs All previous publications are listed on the UKGPCS website: www.icr.ac.uk/ukgpcs • Presentations at appropriate conferences 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. The outputs will be communicated to relevant recipients through the following dissemination channels: • Journals • Participant newsletters (used historically) • UKGPCS website The target dates are from the end of 2024 up to 2027. The Data Controller intends to create a dataset under this Data Sharing Agreement. NHS England will then decide whether it may be categorised as Derived Data under the definition set out in the DSFC.

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. The use of the data could : • help the system to better understand the health and care needs of populations. • lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. The study aims to find genetic changes which are associated with prostate cancer risk. If the study can find alterations in genes that increase the chances of getting prostate cancer, it may be possible in the future to use this knowledge: o To screen other family members to see if they are also at a higher risk of developing prostate cancer, o To develop new prostate cancer treatments for the future. The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer. Greater than 400 regions of the genome have now been associated with prostate cancer (the majority found by our research group), and we can now begin to analyse what effects these “risk regions” have on prostate cancer aggressiveness and outcome. Our aims are to find new genetic markers to identify who might be at risk of developing prostate cancer in the future; to be able to more accurately target appropriate treatments to those patients who are most likely to have aggressive disease and to develop new treatments for prostate cancer. This has the potential to be able to target screening to those who would benefit from this manoeuvre and the potential to improve survival.

Benefits reported

Not stated in the previous version; added here.

The academic papers produced have contributed to the body of evidence which informs the public and/or key decision-makers involved in the health/social care system including medical professionals and policy-makers.

The NHS England data received for the UKGPCS study have been used to develop a genetic risk model that can provide personalised predicted prostate cancer risks on the basis of known moderate-to high-risk pathogenic variants, low-risk common genetic variants, and explicit cancer family history. The model will assist in counselling men concerned about their risk and can facilitate future risk-stratified population screening approaches.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

Under this Data Sharing Agreement, the Institute of Cancer Research (ICR) is permitted to securely retain data that was supplied between 2011 and 2019 for an interim period in which under previous iterations of this DSA. The DSA does not permit any other processing of the actions described below must be completed. data. During the term of this Agreement, the data must be stored in a secure location and may not be processed for any other purpose. In the event that the ICR has previously shared data covered by this Agreement, in any form which does not meet the definition of Derived Data as stipulated in the ICR's Data Sharing Framework Contract, the ICR is must make reasonable efforts to secure that data including data destruction where possible or ensuring data is securely stored and not otherwise processed where data destruction is not possible. [1 paragraph unchanged] The study recruited patients who gave consent to participate in the study. [36 words unchanged] provided back to the ICR for the purpose of the study. NHS Digital England currently holds the details of 19,324 study participants. [10 paragraphs unchanged] NHS Digital England has reviewed the patient information and consent forms used in recruitment and [9 words unchanged] legal basis for processing confidential patient data for all study participants involved. NHS Digital England requires the ICR to review the roles of the organisations involved in [10 words unchanged] organisations are and are not data controllers as supported by the facts. NHS Digital England notes that the ICR has supplied "anonymised data from this to other studies under an MTA" (Material Transfer Agreement). NHS Digital England requires clarification of whether any data covered by this Agreement has been [13 words unchanged] data under this Agreement in the future subject to the necessary approvals.

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. Under this Data Sharing Agreement, the Institute of Cancer Research (ICR) is permitted to retain data that was supplied under previous iterations of this DSA. The DSA does not permit any other processing of the data. Permission for the ICR to retain and reuse the data previously supplied beyond the term of this Data Sharing Agreement will be contingent on the ICR's ability to evidence a legal basis for continuing access to patient confidential data and will be subject to approval of a future application meeting all NHS Digital data sharing standards that apply. See: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance In order for the cohort to be linked the following identifiers were supplied to NHS England (*or predecessor organisations): The study data, including data provided by NHS Digital under previous Agreements, are currently held by The Institute of Cancer Research. In order for the cohort to be linked the following identifiers were supplied to NHS Digital (*or predecessor organisations): [7 paragraphs unchanged] NHS Digital* England* returned the following data to the Institute of Cancer Research: [4 paragraphs unchanged]

Unchanged: Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[3 paragraphs unchanged] The data was originally supplied to the ICR under a Data Sharing Agreement with the ICR and the Royal Mardsen Marsden NHS Foundation Trust for the purpose of the UK Genetic Prostate Cancer [14 words unchanged] cancer study of its kind in the UK, involving nearly 200 hospitals. [14 paragraphs unchanged]

Unchanged: Processing activities, Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Cancer Registration Data; + Civil Registrations of Death; + Demographics

Objective for processing

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling The Institute of Cancer Research to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). Under this Data Sharing Agreement, the Institute of Cancer Research (ICR) is permitted to securely retain data supplied between 2011 and 2019 for an interim period in which the actions described below must be completed. The following provides background information on the purpose of the original study: During the term of this Agreement, the data must be stored in a secure location and may not be processed for any other purpose. The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer. 130 regions of the genome have now been associated with prostate cancer (the majority found by our research group), and we can now begin to analyse what effects these “risk regions” have on prostate cancer aggressiveness and outcome. Our aims are to find new genetic markers to identify who might be at risk of developing prostate cancer in the future; to be able to more accurately target appropriate treatments to those patients who are most likely to have aggressive disease and to develop new drug treatments for prostate cancer. This has the potential to be able to target screening to those who would benefit from this manoeuvre and the potential to improve survival. In the event that the ICR has previously shared data covered by this Agreement, in any form which does not meet the definition of Derived Data as stipulated in the ICR's Data Sharing Framework Contract, the ICR is must make reasonable efforts to secure that data including data destruction where possible or ensuring data is securely stored and not otherwise processed where data destruction is not possible. (see point 10) The data was originally supplied to the ICR under a Data Sharing Agreement with the ICR and the Royal Mardsen NHS Foundation Trust for the purpose of the UK Genetic Prostate Cancer Study (UKGPCS). The UKGPCS was first established in 1992 and is the largest prostate cancer study of its kind in the UK, involving nearly 200 hospitals. The study recruited patients who gave consent to participate in the study. Identifying details of consented participants were provided to NHS Digital (or predecessor organisations) for linkage. Notifications of participant deaths (date and cause of death), cancer registrations and Demographics data (NHS number, Forenames/Surname, latest patient registration) were provided back to the ICR for the purpose of the study. NHS Digital currently holds the details of 19,324 study participants. By 2021, the study had recruited over 22,500 participants and aimed to recruit 26,000 by the end of 2022. Each consented patient gives a blood/saliva sample, and a family history questionnaire, and The Institute of Cancer Research (ICR) obtain clinical data from their referring hospital or consultant. The study aims to find genetic changes which are associated with prostate cancer risk. If the study can find alterations in genes that increase the chances of getting prostate cancer, it may be possible in the future to use this knowledge: o To screen other family members to see if they are also at a higher risk of developing prostate cancer, o To develop new prostate cancer treatments for the future. The ICR’s legal basis for processing this information is for the performance of a task carried out in the public interest Article 6 (1) (e). The ICR processes sensitive health and genetic information for the purposes of scientific research with appropriate safeguards in place to protect personal information, (Article 9 (2) (j), as required by the EU General Data Protection Regulation. The data subjects are men who fit into at least one of the following groups: o They have been diagnosed with prostate cancer and a first, second or third degree relative where at least one of these men were diagnosed with prostate cancer at 65 years of age or under. o They are affected and have 3 or more cases of prostate cancer on one side of their family. o They are a prostate cancer patient at the Royal Marsden NHS Foundation Trust. o They are taking part in the CyberKnife prostate SBRT studies. NHS Digital has reviewed the patient information and consent forms used in recruitment and requires the ICR to provide further reassurance of a legal basis for processing confidential patient data for all study participants involved. NHS Digital requires the ICR to review the roles of the organisations involved in the study and to provide a clear explanation of which organisations are and are not data controllers as supported by the facts. NHS Digital notes that the ICR has supplied "anonymised data from this to other studies under an MTA" (Material Transfer Agreement). NHS Digital requires clarification of whether any data covered by this Agreement has been shared with third parties and/or whether there is an intention to onwardly share data under this Agreement in the future subject to the necessary approvals.

Processing activities

[1 paragraph unchanged] Permission for the ICR to retain and reuse the data previously supplied beyond the term of this Data Sharing Agreement will be contingent on the ICR's ability to evidence a legal basis for continuing access to patient confidential data and will be subject to approval of a future application meeting all NHS Digital data sharing standards that apply. See: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance [1 paragraph unchanged] The following provides background on the processing activities undertaken prior to this Agreement: In order for the cohort to be linked the following identifiers were supplied to NHS Digital (*or predecessor organisations): Standard time-to-event analysis will be used to test for association between genotype and prognosis. Time at risk will begin on the date of diagnosis, with time under observation beginning on date of blood sample receipt. Follow-up will be censored on the date of death from any cause, or, if death did not occur, on the date of the end of the study. o NHS Number We already have genotype data, date of diagnosis and date of blood receipt for all our cases. We therefore request death certificate data to enable us to obtain date of death and cause of death for those men in UKGPCS who have died. o Forenames (see point 12) o Surname o Date of Birth o Sex o Postcode o Study ID NHS Digital* returned the following data to the Institute of Cancer Research: o Civil Registration Deaths o Demographic Data: NHS number, Forenames/Surname, latest patient registration o Cancer Data: Cancer registration number, type, and behaviour code of cancer. Cancer registry centre code, ICD10 site code as well as cancer anniversary year/month and day. The ICR has not been authorised to onwardly share the data above.

Expected output

[2 paragraphs unchanged] The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer All previous publications are listed on the UKGPCS website: www.icr.ac.uk/ukgpcs

Expected measurable benefits

[1 paragraph unchanged] The UKGPCS has been running since 1992, and gained MREC approval in 2003. The study is UK wide and currently 180 hospitals recruit prostate cancer patients with young onset or familial prostate cancer into the study. The Royal Marsden Hospital has ethical approval to recruit prostate cancer patients of any age to the study. Currently there are 22,000 patients consented to the study, and the target is 26,000 by the end of 2022. Each consented patient gives a blood/saliva sample, and a family history questionnaire, and we obtain clinical data from their consultant. Not all patients have given consent to re contact them and we do not have current addresses for many of the participants, some of whom were recruited more than 10 years ago.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: − MRIS - Personal Demographics Service; − MRIS - Scottish NHS / Registration

Objective for processing

The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer. 31 regions of the genome have now been associated with prostate cancer (the majority found by our research group), and we can now begin to analyse what effects these “risk regions” have on prostate cancer aggressiveness and outcome. Our aims are to find new genetic markers to identify who might be at risk of developing prostate cancer in the future; to be able to more accurately target appropriate treatments to those patients who are most likely to have aggressive disease and to develop new drug treatments for prostate cancer. This has the potential to be able to target screening to those who would benefit from this manoeuvre and the potential to improve survival. This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling The Institute of Cancer Research to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). The following provides background information on the purpose of the original study: The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer. 130 regions of the genome have now been associated with prostate cancer (the majority found by our research group), and we can now begin to analyse what effects these “risk regions” have on prostate cancer aggressiveness and outcome. Our aims are to find new genetic markers to identify who might be at risk of developing prostate cancer in the future; to be able to more accurately target appropriate treatments to those patients who are most likely to have aggressive disease and to develop new drug treatments for prostate cancer. This has the potential to be able to target screening to those who would benefit from this manoeuvre and the potential to improve survival. [1 paragraph unchanged]

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. The study data, including data provided by NHS Digital under previous agreements, are currently held by The Institute of Cancer Research. The following provides background on the processing activities undertaken prior to this Agreement: [3 paragraphs unchanged]

Expected output

This Agreement permits the secure retention of the data only and no other processing. No new outputs will be produced under this Data Sharing Agreement. [1 paragraph unchanged]

Expected measurable benefits

The UKGPCS has been running since 1992, and gained MREC approval in 2003. The study is UK wide and currently 162 hospitals recruit prostate cancer patients with young onset or familial prostate cancer into the study. The Royal Marsden Hospital has ethical approval to recruit prostate cancer patients of any age to the study. Currently there are 10,491 patients consented to the study, and the target is 21,000 by the end of 2012. This Agreement permits the secure retention of the data only and no other processing. Each consented patient gives a blood sample, and a family history questionnaire, and we obtain clinical data from their consultant. Not all patients have given consent to re contact them and we do not have current addresses for many of the participants, some of whom were recruited more than 10 years ago. The UKGPCS has been running since 1992, and gained MREC approval in 2003. The study is UK wide and currently 180 hospitals recruit prostate cancer patients with young onset or familial prostate cancer into the study. The Royal Marsden Hospital has ethical approval to recruit prostate cancer patients of any age to the study. Currently there are 22,000 patients consented to the study, and the target is 26,000 by the end of 2022. Each consented patient gives a blood/saliva sample, and a family history questionnaire, and we obtain clinical data from their consultant. Not all patients have given consent to re contact them and we do not have current addresses for many of the participants, some of whom were recruited more than 10 years ago.

Benefits reported

Stated in the previous version and removed here.

Yielded Benefits is not a requirement for new applications.