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Arm K Patient Information Sheet

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STAMPEDE Trial

We are inviting you to take part in a research study called STAMPEDE

·  This information leaflet is for men who have been allocated to Treatment Group K in STAMPEDE.

·  You will receive standard hormone treatment as well as metformin.

·  Your doctor will also discuss whether your standard treatment will include chemotherapy.

·  Please take your time reading this information. Discuss it with friends and relatives if you wish.

·  Make a note of any questions you might have and discuss them with your doctor or nurse

·  Please always tell your doctor or nurse of any sideeffects you experience on treatment to make sure you get support in managing these

·  This sheet should be read with the General Patient Information Sheet Part 1 and General Patient Information Sheet Part 2

·  In this information sheet, the term “study” and “clinical trial” will be used interchangeably and they are intended to mean the same thing.

Contents

1  Why is metformin being tested as a treatment for prostate cancer?

2  Will my standard treatment change?

3  How is metformin given?

4  What if I miss a dose?

5  What are the possible side effects?

6  How long will I be on treatment for?

7  Situations when I should pause metformin

8  Will metformin interact with other medications?

9  What to do if I feel unwell

10 Where can I find out more?

11 Further information

How to contact us

If you have any questions about this study, please talk to your doctor or nurse:

Name of doctor or nurse

Hospital Department

Hospital

Address

Address

Tel: 01234 XXX XXX

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1 / Why is metformin being tested as a treatment for prostate cancer?

Metformin is a tablet treatment currently used in the management of Type 2 diabetes.

Metformin affects the metabolism of sugars and fats. It is thought that metformin may prevent some of the metabolic effects of hormone treatment. These include weight gain and insulin resistance which may lead to diabetes and increase the risk of heart disease. Studies have also shown that metformin may prevent prostate cancer growth and progression.

We are testing whether adding metformin to the current standard treatment enables men to live longer. We will also assess the effects on weight, glucose control and whether it prevents the development of diabetes and heart disease.

2 / Will my standard treatment change?

No. As detailed in the Patient Information Sheet Part 1, your doctor will discuss which standard treatments are recommended for you. All research treatments are given in addition to standard treatments which remain unaffected if you take part in STAMPEDE.

Standard treatment will always include a type of hormone treatment. Prostate cancers need the male testosterone to grow. Hormone treatments work by stopping testosterone from reaching prostate cancer cells. They can help to control the growth of the cancer wherever it is in the body.

All men joining the study will be starting long-term hormone treatment (treatment lasting for at least 2 years). If you have advanced prostate cancer that has spread to other parts of the body (metastatic prostate cancer) hormone treatment is continued life-long.

If you have localised prostate cancer (confined to the prostate and nearby lymph nodes) you will remain on hormone treatment for a minimum of 2 years.

Research has shown us that men with localised prostate cancer benefit from radiotherapy. Because of this, it is now recommended as part of standard treatment if:

·  Your cancer remains within the prostate

·  Your cancer is within the prostate and nearby lymph glands in the pelvis

Your clinical oncologist (radiotherapy doctor) will discuss whether this is suitable for you.

Recent results from STAMPEDE and another clinical trial (called CHAARTED) have shown that, in men starting hormonal treatment for the first time, adding chemotherapy to standard treatment controls prostate cancer for longer and, in both studies, men who received chemotherapy live longer. You and your doctor should have discussed if chemotherapy is recommended for you.

3 / How is metformin given?

Metformin is a tablet treatment. The starting dose is one 850mg tablet taken once a day with or after food. After 4-6 weeks of treatment and having reviewed any side effects, your research team will discuss increasing the dose to 850mg twice a day. You should aim to take your tablets at the same time each day, a minimum of 8 hours apart, for example with or after breakfast and your evening meal.

You will always receive your prescription for metformin from your oncology research team.

4 / What if I miss a dose?

It is very important that you tell your research doctor or nurse if you miss any doses or take the wrong number of tablets. If you forget to take your metformin tablets at the regular time, you can take them as soon as you remember that day. However, if you forget to take your drugs for the whole day, just take your normal doses at your regular time the next day. Do not try to make up for a missed dose by taking a double dose or extra dose on the next day. Please try and make a note of any doses that you miss as your research team will ask you this at each clinic visit. It is helpful if you record the dates of any treatment pauses.

5 / What are the possible side effects of metformin?

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.

6 / How long will I be on treatment for?

How long you remain on treatment with metformin depends on the stage of your prostate cancer when you join the study.

If your prostate cancer has spread to other parts of the body (metastatic prostate cancer) you should remain on metformin life-long providing you are able and willing to take it.

If you have localised prostate cancer you should continue to take metformin for a minimum of 3 years after you join the study and whilst you are receiving long-term standard hormone treatment (whichever is longer). If your standard hormone treatment stops you should continue metformin for a further 12 months after your last LHRH injection or implant was given to allow sufficient time for your testosterone level to return to normal. If hormone treatment is re-started whilst you remain on metformin (i.e. within 12 months of stopping) then metformin should continue whilst you are on standard hormone treatment.

You can also choose to stop metformin at any point should you wish but please discuss this more with your research nurse or doctor so they are aware and know why.

You will require monitoring with blood tests every 3-6 months whilst on metformin to confirm that it is safe for you to continue.

7 / Important situations when metformin needs to be paused

Always make sure your doctors, nurses and pharmacist are aware that you are taking metformin. There are some circumstances where you should pause metformin. These include:

·  CT scans with contrast: stop metformin the day before the scan and re-start 2 days afterwards.

·  Surgery or procedures requiring a general anaesthetic: stop treatment the day before and re-start 2 days afterwards providing you are eating and drinking normally

·  If you become dehydrated, for example, experience severe diarrhoea, vomiting or are unable to eat and drink: stop metformin and seek medical advice. Only re-start once eating and drinking normally.

8 / Will metformin interact with my other medications?

Metformin can be safely taken with all other treatments for prostate cancer. You should tell your research team about all your current medications to check for any interactions. You should always tell your doctor or pharmacist that you are taking metformin especially when starting tablets to treat high blood pressure. Non-steroidal pain killers such as ibuprofen should be avoided if possible.

You should also avoid drinking alcohol excessively.

9 / What do I do if I feel unwell?

Please always tell your doctor or nurse about any new symptoms you experience whilst on treatment.

If you become unwell between hospital visits, please seek advice immediately, either from your hospital or from your GP.

Please update your research team if you attend your GP or hospital for problems relating to your prostate cancer.

10 / Some things to read

This information sheet should be read together with General Patient Information Sheet- Part 1 and General Patient Information Sheet- Part 2 for detailed information.

Table 1 below provides an overview on all information leaflets available for you to read.

Please make a note of any questions you might have and talk to your doctor or research nurse.

11 / Further information

If you want further information about the STAMPEDE study, contact your study doctor or nurse (see below).

[Insert address and telephone number of study doctor and/or nurse]

Useful contacts and where to find out more:

www.macmillian.org.uk

www.prostatecanceruk.org/prostate-information

More information is also available on our website www.stampedetrial.org.

Thank you for taking the time to consider taking part in this study

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Table 1

STAMPEDE: Patient Information Sheets
Which Patient Information Sheet (PIS)? / Content / Who should read it? / When?
General PIS Part 1 / Overview of why the study is being done and what it involves / Everyone interested in taking part / When being approached about the study
General PIS Part 2 / Details of study conduct and oversight / Everyone interested in taking part / When being approached about the study
Arm A, K and L PIS / Details of treatment associated with each arm of the study / Everyone interested in taking part / Before randomisation and informed consent
Additional Research PIS / Details of quality of life study and other optional studies / Everyone interested in taking part / Before randomisation and informed consent

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