Clinical trial: NCT05326282
Section: Confidentiality
Subsections: Your Information And Data Protection

In this research study, we will use information from the workshop discussions to produce a narrative of main themes related to prostate imaging. We will only use information that we need for the research study. We will collect a list of  
  
participants who consent to being contacted after the workshop. Only the research team will have access to this data and it will be stored on a passwordprotected database.  
The data we collect from the workshop will include notes of discussion but this will not be attributed to individuals or to specific trusts / health care providers. People will use this information to do the research. People who do not need to know who you are will not be able to see your name or contact details. We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.  
Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used?  
You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/ our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 4 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my role or legal rights  being affected. I agreed to being contacted after this workshop  related to discussions about prostate imaging I agree to take part in the above study. I decline to participate in the above study and do not  wish for my comments to be recorded Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |
Clinical trial: NCT05326282
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Benefits For Me?|Is There Any Risk?|What Are The Benefits Of Me Joining This Research?

By taking part in this study, you will be helping patients of the future and will be helping Hull remain at the forefront of patient care. The data we collect may not be able to change your treatment but it will help men, like you, who are patients in the future. With your permission, will inform your consultant of anything incidental that we find on the scans as part of this research, and keep in close contact with you throughout.  
How will my scan change if I choose to take part?  
 You will have a standard MRI scan as requested by your doctor or nurse. After that, we will arrange for you to have an ultrasound scan of your prostate. If you need a biopsy following your MRI, we will arrange to do this research scan at the same time. If you do not need a biopsy, we will arrange a convenient time for you to attend for an ultrasound scan that will be used in this study. For this study, there will be two different ultrasound machines together in the room rather than one. Your prostate will be scanned using both machines, one after the other. After the scans have been completed we will then continue to undertake the prostate biopsy if needed or we will finish the examination and you will be free to go home.  
The scans involve a narrow ultrasound probe being inserted a small way into the rectum. This will be similar to the digital rectal examination that you have had from your doctor or nurse. It will not be painful and we will stop the examination if you feel discomfort. The probe will be moved around a little and pictures of your prostate will be taken. The probe will be removed. A second probe will be inserted and the scan repeated using the new micro-ultrasound technology. Each scan will take no more than 5 minutes to complete.  
The initial scan described above will be the same as if this research was not being done. The second examination is being done purely for this research study.  
The pictures from the scans will be stored anonymously and will be compared to the MRI scan by independent reviewers, either a radiologist or a specialist sonographer. The outcomes of the reviews will be recorded on a secure, password protected database accessible only to the research team. We will record the result of your latest prostate serum antigen (PSA) blood test which we access from the hospital electronic record system - this is something we do routinely as knowing your blood tests can be important to relate to the scan pictures we normally look at. We will also record the outcomes of any biopsies you have had taken. This extra information will let us see if there are any ultrasound features of the prostate that match the tissue sample readings the laboratories produce.

There are no known risks of having an ultrasound scan. Ultrasound is a very safe test. Will this affect my treatment or care?  
 Being involved in this research will not affect how you are treated or cared for in any way.  
Do I have to take part?  
You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect how you are treated or cared for in any way.  
Prior to your MRI you will be contacted by me, Pamela Parker, the lead researcher for this study. I will contact you by 'phone to explain more about our research and to seek your consent to join this study.

This research is being undertaken on men who are being monitored so that we can increase our understanding of the benefits of using micro-ultrasound in the monitoring of prostate cancer. Being able to scan men who are currently being monitored will allow us to compare this new technology with the routine regular tests available. This will provide us with a valuable insight into the capabilities of this new technology. The data we collect will help improve the monitoring of men in the future. By taking part in this trial you will be helping patients of the future and will be helping Hull remain at the forefront of patient care.  
The data we collect may not be able to change your treatment but it will help men, like you, who are patients in the future. With your permission, will inform your consultant of anything incidental that we find on the scans as part of this research, and keep in close contact with you throughout.  
How will my monitoring change if I choose to take part?  
  
You will have routine blood tests and digital rectal examinations regularly as part of your prostate monitoring. For this research, you will be invited to have ultrasound scans in addition to the routine tests. The first ultrasound scan will be done in the next few weeks and then every 6-months for the duration of the study. You will be invited to a minimum of 1 and a maximum of 4 scans for this study. We will arrange a convenient time for you to attend for each of the ultrasound scans that will be used in this study.  
When you attend for the ultrasound scans, there will be two different ultrasound machines together in the room rather than one. Your prostate will be scanned using both machines, one after the other. After the scans have been completed you will be free to go home.  
The scans involve a narrow ultrasound probe being inserted a small way into the rectum. This will be similar to the digital rectal examination that you have had from your doctor or nurse. It will not be painful and we will stop the examination if you feel discomfort. The probe will be moved around a little and pictures of your prostate will be taken. The probe will be removed. A second probe will be inserted and the scan repeated using the new micro-ultrasound technology. Each scan will take no more than 5 minutes to complete. Both of these scans are being done purely for this research study. They are in addition to your routine care. The pictures from the scans will be compared to your previous MRI scan by independent reviewers, either a radiologist or a specialist sonographer. If you participated in phase 1 of this study, the pictures will also be compared to the previous ultrasound scans you had taken. The outcomes of the reviews will be recorded on a secure, password protected database accessible only to the research team.  
We will record the result of your latest prostate serum antigen (PSA) blood test which we access from the hospital electronic record system - this is something we do routinely as knowing your blood tests can be important to relate to the scan pictures we normally look at. We will also record the outcomes of any biopsies you have previously had taken. This extra information will let us see if there are any ultrasound features of the prostate that match the tissue sample readings the laboratories produce. Is there any risk?  
 There are no known risks of having an ultrasound scan. Ultrasound is a very safe test. Will this affect my treatment or care? Being involved in this research will not affect how you are treated or cared for in any way.
Clinical trial: NCT05326282
Section: Purpose of Research
Subsections: Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?|Why Have I Been Invited To Take Part?

You have been referred to urology for investigations of your prostate. The Consultant in charge of your care, or one of the doctors or nurses in your team, have asked us to do an MRI scan of your prostate. This looks at the prostate gland and can highlight areas of change that may indicate the need for biopsy. This research is being undertaken on men who have an MRI of the prostate that we can directly compare with the micro-ultrasound pictures, providing us with a valuable insight into the capabilities of this new technology. The data we collect will help improve diagnosis and biopsy planning for future patients. This is particularly important for men who cannot have MRI scans and to help the NHS cope with the demands for its services.

You will have previously been investigated for suspected prostate cancer and have had an MRI scan. You may also have had a biopsy of your prostate although not all men do. Your consultant has diagnosed low grade prostate cancer and you are being monitored for any evidence of progression. This is known as active surveillance or watchful waiting. Whilst being monitored you will have regular blood tests and digital rectal examinations. Occasionally you may also be referred for an MRI scan. These routine tests can give us an indication of whether your prostate gland is stable or changing. However, published evidence suggests that micro-ultrasound will be able to add valuable information to the doctors looking after patients being monitored in the future that may lead to earlier treatment than they can currently provide.

You are attending this study event and, therefore, have some background and knowledge of imaging and prostate cancer care. Your feedback will be valuable to us to help us evaluate the usefulness of our trial and its subsequent implementation into every day clinical practice.  
What does phase 4 **of the research look like?**  
 Following the presentations and demonstrations today, there will be a question and answer forum. Notes will be taken from this Q&A session and these will be recorded a narrative so that the main themes, barriers and opportunities can be evaluated at a later date. All notes will be taken anonymously and no personal identifiable data will be recorded. No comments recorded will be attributable to any attendee. This study is being undertaken as part of a PhD thesis with the University of Hull and the Hull Teaching Hospitals Trust.

You have been referred to urology for investigations of your prostate. The Consultant in charge of your care, or one of the doctors or nurses in your team, have asked us to do an MRI scan of your prostate. This looks at the prostate gland and can highlight areas of change that may indicate the need for biopsy. This research is being undertaken on men who have an MRI of the prostate that we can directly compare with the micro-ultrasound pictures, providing us with a valuable insight into the capabilities of this new technology. The data we collect will help improve diagnosis and biopsy planning for future patients. This is particularly important for men who cannot have MRI scans and to help the NHS cope with the demands for its services.

You will have previously been investigated for suspected prostate cancer and have had an MRI scan. You may also have had a biopsy of your prostate although not all men do. Your consultant has diagnosed low grade prostate cancer and you are being monitored for any evidence of progression. This is known as active surveillance or watchful waiting. Whilst being monitored you will have regular blood tests and digital rectal examinations. Occasionally you may also be referred for an MRI scan. These routine tests can give us an indication of whether your prostate gland is stable or changing. However, published evidence suggests that micro-ultrasound will be able to add valuable information to the doctors looking after patients being monitored in the future that may lead to earlier treatment than they can currently provide.

You are attending this study event and, therefore, have some background and knowledge of imaging and prostate cancer care. Your feedback will be valuable to us to help us evaluate the usefulness of our trial and its subsequent implementation into every day clinical practice.  
What does phase 4 **of the research look like?**  
 Following the presentations and demonstrations today, there will be a question and answer forum. Notes will be taken from this Q&A session and these will be recorded a narrative so that the main themes, barriers and opportunities can be evaluated at a later date. All notes will be taken anonymously and no personal identifiable data will be recorded. No comments recorded will be attributable to any attendee. This study is being undertaken as part of a PhD thesis with the University of Hull and the Hull Teaching Hospitals Trust.

You have been referred to urology for investigations of your prostate. The Consultant in charge of your care, or one of the doctors or nurses in your team, have asked us to do an MRI scan of your prostate. This looks at the prostate gland and can highlight areas of change that may indicate the need for biopsy. This research is being undertaken on men who have an MRI of the prostate that we can directly compare with the micro-ultrasound pictures, providing us with a valuable insight into the capabilities of this new technology. The data we collect will help improve diagnosis and biopsy planning for future patients. This is particularly important for men who cannot have MRI scans and to help the NHS cope with the demands for its services.

You will have previously been investigated for suspected prostate cancer and have had an MRI scan. You may also have had a biopsy of your prostate although not all men do. Your consultant has diagnosed low grade prostate cancer and you are being monitored for any evidence of progression. This is known as active surveillance or watchful waiting. Whilst being monitored you will have regular blood tests and digital rectal examinations. Occasionally you may also be referred for an MRI scan. These routine tests can give us an indication of whether your prostate gland is stable or changing. However, published evidence suggests that micro-ultrasound will be able to add valuable information to the doctors looking after patients being monitored in the future that may lead to earlier treatment than they can currently provide.

You are attending this study event and, therefore, have some background and knowledge of imaging and prostate cancer care. Your feedback will be valuable to us to help us evaluate the usefulness of our trial and its subsequent implementation into every day clinical practice.  
What does phase 4 **of the research look like?**  
 Following the presentations and demonstrations today, there will be a question and answer forum. Notes will be taken from this Q&A session and these will be recorded a narrative so that the main themes, barriers and opportunities can be evaluated at a later date. All notes will be taken anonymously and no personal identifiable data will be recorded. No comments recorded will be attributable to any attendee. This study is being undertaken as part of a PhD thesis with the University of Hull and the Hull Teaching Hospitals Trust.
Clinical trial: NCT05326282
Section: Voluntary Participation
Subsections: Consent|Consent|Consent|Do I Have To Take Part?|Do I Have To Take Part?|Do I Have To Take Part?|Consent|Consent|Consent|Do I Have To Take Part?|Do I Have To Take Part?|Do I Have To Take Part?|Do I Have To Take Part?|Do I Have To Take Part?|Do I Have To Take Part?|Consent|Consent|Consent

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section. Information about me, Pamela Parker the lead researcher  
 I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study we will use information from your MRI, ultrasound and biopsy investigations. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study.  
The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.  
Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study. What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used?  
You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to me pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study, we will use information from your MRI, ultrasound and biopsy investigations. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly.  
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/  
  
our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 2 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my medical care or  legal rights being affected. I understand that incidental findings may be  detected during the scans. I give permission for  these to be shared with my consultant I understand that relevant sections of my medical  notes and data collected during the study may be  looked at by individuals from regulatory authorities  or from the NHS Trust, where it is relevant to my  taking part in this research. I give permission for  these individuals to have access to my records. I agree to my consultant being informed of my  participation in the study.  I agree to take part in the above study. Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect how you are treated or cared for in any way.  
Once you have been given a diagnosis from the doctor looking after you and agreed a monitoring plan you will be contacted by me, Pamela Parker, the lead researcher for this study. I will contact you by 'phone to explain more about our research and to seek your consent to join this study. Thank you considering this invitation.

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect your current role or clinical practice.  
Thank you for considering and taking part in this valuable study. I will contact you in the next few weeks to discuss the study with you. If you are happy to proceed I will ensure that you are sent a secure and individual link to the survey.  
The survey will be sent again in 6 - 12 months so that any changes in your opinion of this new technology can be captured. A maximum of two surveys will be sent.  
Consent  
 You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study we will use information from your survey results to inform how new technology can be implemented in practice. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly.  
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used?  
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
our leaflet available from the urology nurse specialist or from ultrasound, at  
  
Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 3 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my role or legal rights  being affected. I agree to take part in the above study. Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect your attendance at this study event. Your comments will not be recorded and will not form part of the narrative review.  
Thank you for considering and taking part in this valuable study. If you are happy to participate, please sign the accompanying consent form which will be collected by one of the research team. If you would prefer to not be involved, please indicate this on the accompanying form and your preference will be noted.

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section. Information about me, Pamela Parker the lead researcher  
 I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study we will use information from your MRI, ultrasound and biopsy investigations. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study.  
The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.  
Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study. What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used?  
You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to me pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study, we will use information from your MRI, ultrasound and biopsy investigations. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly.  
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/  
  
our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 2 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my medical care or  legal rights being affected. I understand that incidental findings may be  detected during the scans. I give permission for  these to be shared with my consultant I understand that relevant sections of my medical  notes and data collected during the study may be  looked at by individuals from regulatory authorities  or from the NHS Trust, where it is relevant to my  taking part in this research. I give permission for  these individuals to have access to my records. I agree to my consultant being informed of my  participation in the study.  I agree to take part in the above study. Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect how you are treated or cared for in any way.  
Once you have been given a diagnosis from the doctor looking after you and agreed a monitoring plan you will be contacted by me, Pamela Parker, the lead researcher for this study. I will contact you by 'phone to explain more about our research and to seek your consent to join this study. Thank you considering this invitation.

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect your current role or clinical practice.  
Thank you for considering and taking part in this valuable study. I will contact you in the next few weeks to discuss the study with you. If you are happy to proceed I will ensure that you are sent a secure and individual link to the survey.  
The survey will be sent again in 6 - 12 months so that any changes in your opinion of this new technology can be captured. A maximum of two surveys will be sent.  
Consent  
 You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study we will use information from your survey results to inform how new technology can be implemented in practice. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly.  
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used?  
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
our leaflet available from the urology nurse specialist or from ultrasound, at  
  
Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 3 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my role or legal rights  being affected. I agree to take part in the above study. Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect your attendance at this study event. Your comments will not be recorded and will not form part of the narrative review.  
Thank you for considering and taking part in this valuable study. If you are happy to participate, please sign the accompanying consent form which will be collected by one of the research team. If you would prefer to not be involved, please indicate this on the accompanying form and your preference will be noted.

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect how you are treated or cared for in any way.  
Once you have been given a diagnosis from the doctor looking after you and agreed a monitoring plan you will be contacted by me, Pamela Parker, the lead researcher for this study. I will contact you by 'phone to explain more about our research and to seek your consent to join this study. Thank you considering this invitation.

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect your current role or clinical practice.  
Thank you for considering and taking part in this valuable study. I will contact you in the next few weeks to discuss the study with you. If you are happy to proceed I will ensure that you are sent a secure and individual link to the survey.  
The survey will be sent again in 6 - 12 months so that any changes in your opinion of this new technology can be captured. A maximum of two surveys will be sent.  
Consent  
 You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study we will use information from your survey results to inform how new technology can be implemented in practice. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly.  
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used?  
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
our leaflet available from the urology nurse specialist or from ultrasound, at  
  
Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 3 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my role or legal rights  being affected. I agree to take part in the above study. Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |

You do not have to take part in this research if you do not want to - it is completely your choice and we will not ask why you have or have not decided to be involved. Not being involved in this research will not affect your attendance at this study event. Your comments will not be recorded and will not form part of the narrative review.  
Thank you for considering and taking part in this valuable study. If you are happy to participate, please sign the accompanying consent form which will be collected by one of the research team. If you would prefer to not be involved, please indicate this on the accompanying form and your preference will be noted.

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section. Information about me, Pamela Parker the lead researcher  
 I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study we will use information from your MRI, ultrasound and biopsy investigations. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study.  
The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.  
Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study. What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used?  
You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/
our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to me pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch Your information and data protection In this research study, we will use information from your MRI, ultrasound and biopsy investigations. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. The data we collect will include your initials and a code number held on the secure hospital server. People will use this information to do the research or to check your records to make sure that the research is being done properly.  
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  
We will keep all information about you safe and secure. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. Once we have finished the study, we will keep some of the data for a maximum of three years so we can check the results. The data will then be securely deleted. We will write our reports in a way that no-one can work out that you took part in the study.  
What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.  
Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/  
  
our leaflet available from the urology nurse specialist or from ultrasound, at Castle Hill Hospital, by asking one of the research team, by sending an email to pamela.parker6@nhs.net or ResearchDevelopment@nhs.net , by ringing us on (01482) 623065 Our data protection officer can be contacted via email to HEYIG@nhs.net Participant Consent Form - Phase 2 Evaluating the Role of Ultrasound in Prostate Cancer Study  
  
(ERUP Study)  
| Name of Chief Investigator: Pamela Parker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Please confirm agreement  to the statements by putting  your initials in  the boxes below   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| I confirm that I have read and understand the information  sheet dated 03/11/2021 (ICF version 2) for the above  study. I have had the opportunity to consider the  information, ask questions and have had these answered  satisfactorily. I understand that my participation is voluntary and  that I am free to withdraw at any time without  giving any reason, without my medical care or  legal rights being affected. I understand that incidental findings may be  detected during the scans. I give permission for  these to be shared with my consultant I understand that relevant sections of my medical  notes and data collected during the study may be  looked at by individuals from regulatory authorities  or from the NHS Trust, where it is relevant to my  taking part in this research. I give permission for  these individuals to have access to my records. I agree to my consultant being informed of my  participation in the study.  I agree to take part in the above study. Participant Signature Date  Name of Participant  Researcher Signature Date  Name of Researcher Pamela Parker |                                                                                             |

You can change your mind and you can withdraw your consent at any time. If you withdraw from the study you will be asked if we can continue to use your data in accordance with the data protection details that follow in the next section.  
Information about me, Pamela Parker the lead researcher I am receiving help from the research and development department within the Trust and the University of Hull as part of a PhD study. Hull University Teaching hospitals is sponsoring this research. All data I collect and store is in accordance with the Health Research Association and information can be found via the HRA link: www.hra.nhs.uk/patientdataandresearch