A trial looking at intermittent versus continuous hormone therapy for prostate cancer that has continued to grow but has not spread (Intercontinental)

Who can enter

You can enter this trial if

• You have prostate cancer that has not spread to another part of your body
• The level of prostate specific antigen (PSA) in your blood is at least 3 nanograms per millilitre (ng/ml), and has started to rise
• You are well enough to have treatment (performance status 0 or 1)
• You have satisfactory blood tests results
• You are willing to use contraception while you are taking part in this trial if there is any chance that your partner could become pregnant
• You are at least 18 years old

You cannot enter this trial if you have

• Been diagnosed with prostate cancer that has spread to another part of your body
• Had hormone therapy or radiotherapy in the last 12 months
• Had internal radiotherapy (brachytherapy) in the last 30 months
• Chronic liver disease
• Any other cancer in the last 5 years, apart from non melanoma skin cancer or superficial bladder cancer (stage Ta or T1)

Trial design

This is a randomised trial. It will recruit about 1340 patients. There are 2 trial groups. The people taking part are put into the groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 will take hormone therapy on and off (intermittently). Group 2 will take hormone therapy all the time (continuously).

If you are in group 1, you will have a hormone treatment called an LHRH analogue. These are sometimes called pituitary down regulators. Examples are goserelin or leuprorelin. You will have the drug by injection once every 1 to 3 months for 8 months. How often you have the injection will depend on which drug you have. You will also take tablets of a hormone treatment called an anti androgen. Examples are flutamide or bicalutamide. You will take this tablet every day for 8 months.

After 8 months, you will stop hormone therapy. You will have blood tests regularly to measure your PSA. If the level of PSA in your blood starts to rise, you will start hormone therapy again. This may be for another 8 months, but may be for longer. The length of treatment will depend on your test results. If you remain well, you may go through several cycles of stopping and starting treatment.

If you are in group 2, you will have an injection of a LHRH analogue every 1 to 3 months, and take an anti androgen every day. You will have hormone treatment continuously rather than stopping after 8 months. You will have blood tests regularly to measure your PSA level.

Hospital visits

You will need to have some tests done before you can take part in this trial. These include blood tests, a chest X-ray and a bone scan.

You will be asked to fill out questionnaires before and during your treatment. The questionnaire will ask you how you have been feeling. It is called a ‘quality of life’ study.

You will need to go to the hospital once every 1 to 3 months for your injection, and every few months to have blood tests. You will have a bone scan every year until your hormone therapy stops working.

Side effects

As with all treatments, hormone therapy has some side effects. These vary depending on which treatment you are given. The most common side effects include

• A decrease in sexual desire and erection problems (impotence)
• Hot flushes and sweating
• Soreness and bruising at injection site

There is more information about the side effects of hormone therapy on CancerHelp UK.