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Arm APatient Information Sheet

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STAMPEDE Trial

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

• This information leaflet provides more information on Treatment Group A in STAMPEDE.
• This group is also referred to as the “control group”.
• Participants in this group will receive standard treatment only.
• Standard treatment will always include a type of hormone treatment.
• Your doctor will also discuss whether your standard treatment will also include radiotherapy or chemotherapy.
• Please take time to read the following information carefully. 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 2and the Additional Research Information Sheet.
• In this information sheet, the term “study” and “clinical trial” will be used interchangeably and they are intended to mean the same thing.

Contents

1What treatments will I receive?

2Will my treatment change as a result of being in the study?

3What are the possible side effects of standard hormone therapy?

4What should I do if I feel unwell?

5Some things to read

6Where can I find out more?

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: XXXXXXXX XXX

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All men in Treatment Group A receive standard treatment.As detailed in the Patient Information Sheet Part 1, your doctor will discuss which standard treatments are recommended for you.

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 lymph glands nearby 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 clinical trials, men who received chemotherapy live longer. You and your doctor should have discussed if chemotherapy is recommended for you.

No, you have been allocated to the “control group”. This means you receive standard treatment alone. Being in the study does not alter the treatment you receive.

Like all treatments, standard hormone therapy may cause some side effects. These are mainly caused by low testosterone levels.

Possible side effects may include hot flushes and changes to your sex life including loss of libido and erection problems. Some men feel more tired and notice they lose muscle and strength. Mild breast swelling and tenderness may also occur as well as loss of some body hair.

Long-term use of hormone therapy is associated with bone thinning and may increase your risk of developing diabetes, heart disease or strokes.

There are treatments and strategies to help manage side effects from hormone therapy so make sure you mention these to your treating doctor or nurse.

We have included some links to other useful sources of information in Section 6 “Where can I find out more?”.

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.

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

Table 1 (on page 4)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.

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:

More information is also available on our website

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

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Table 1: STAMPEDE: Patient Information Sheets

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