MRC Clinical Trials Unit at UCL
90 High Holborn
Patient Frequently Asked Questions
Is your question not answered below? Please check out the 'About' sections of the patients tab for more information or speak to your clinician and nursing staff for more information.
What is the MRC CTU and what does it do?
What are the possible advantages of taking part?
We hope that you will be helped by taking part in this study, but we cannot guarantee this. We hope that the new treatments will help control prostate cancer better than the current standard approach; however, we don’t know this for sure which is why it is being testing in this study.
It is possible that the results may not help you individually but the information we get from this study will help us improve treatments for people like you in the future.
Where are the possible disadvantages of taking part?
If you take part you will need to visit the hospital more often and you are likely to need some extra blood tests. You may have different or extra side effects. The most common unwanted side effects are described in the Treatment Specific Information Sheets, which you can read under the Patient Information Section.
Metformin can cause mild abdominal cramps and diarrhoea. Some people also notice a change in appetite and taste and feel sick. Taking your metformin with or after food can help reduce these side effects. Please tell your research nurse or doctor if this continues to be a problem as changing the type of tablet or reducing the dose may help.
We are testing whether the side effects of transdermal oestradiol are less severe than standard hormone therapy. However we know that transdermal oestradiol may also cause some unwanted side effects, the most common ones are:
- Breast swelling – this may be more likely to occur with the patches than with standard hormone injections.
- Mild skin reactions such as rashes or eczema
- Hot flushes - but these are much less common with transdermal oestradiol than treatment with hormone injections.
In the past, some men who have received oestradiol tablets have had heart or blood-clotting problems. The results from the PATCH study so far show the patches do not have the same problem and no increased risk has been shown compared with standard types of hormone treatment. This will continue to be monitored closely in the STAMPEDE study.
All men taking part in this study will be monitored for these types of medical problems. Please remember to tell your research team if you have any side effects or are admitted to hospital at any time.
Will I need extra hospital visits?
In order to assess the long-term effects of treatment your medical team will need to keep the STAMPEDE researchers updated as to your progress.
Whichever Treatment Group you join, this will likely mean a hospital visit at least every 6 weeks for 6 months, then about every 3 months for the next 2 years and then every 6 months. Once you’ve been part of the study for 5 years the research team will only need to review your progress once a year. However, if you are receiving metformin or transdermal oestradiol, you will need to attend more regularly in order to pick up your medication.
How will my personal information be used?
The STAMPEDE study aims to test if different ways of treating prostate cancer can improve disease control, reduce relapse and improve life expectancy. The Medical Research Council is the sponsor for this study, based in the United Kingdom. University College London (UCL), through the MRC Clinical Trial Centre at UCL, will be using information from you and your medical records in order to undertake this study and will act as data controller for this study. UCL will be responsible for looking after your information and using it properly. UCL will keep identifiable information about you for 25 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally – identifiable information possible.
You can find out more about how we use your information at www.ctu.mrc.ac.uk/general/privacy-policy
Your site will collect information from you and your medical records for this research study in accordance with our instructions.
Your hospital will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from UCL and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your hospital will pass your name, postcode and NHS number to UCL along with the information collected from you and your medical records. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
Your hospital will keep identifiable information about you from this study for at least 25 years after the study has finished.
UCL will collect information about you, for research, from your hospital site, NHS Digital, Public Health England (PHE,) and the National Cancer Registration and Analysis Service (NCRAS). This information will include your name, postcode and NHS number and health information. This health information is regarded as a special category of information as defined by the General Data Protection Regulation (GDPR). We will use this information to track your long term health status (https://digital.nhs.uk/).
Where information could identify you, the information will be held securely with strict arrangements about who can access the information.
Do I have to take part in the study?
No, it is up to you if you want to take part. If you decide not to take part this will not affect the standard of care you receive.
MRC Clinical Trials Unit at UCL