A trial looking at Radium 223 (Alpharadin) for men with prostate cancer that has spread to the bones (ALSYMPCA)

You can enter this trial if

• Your prostate cancer no longer responds to hormone therapy and has spread to your bones
• Your PSA is 5 or above
• You are on painkillers for bone pain or have had external radiotherapy for bone pain in the past 12 weeks
• You are well enough (performance status 0,1, 2)
• You have satisfactory blood results

You cannot enter this trial if you

• Have had a drug as a part of another clinical trial in the past 4 weeks
• Are fit enough and willing to have docetaxel chemotherapy
• Have had chemotherapy in the past 4 weeks
• Have had radiotherapy to a large area of your body (hemi body irradiation)
• Have had radioactive isotopes for bone pain in the past 24 weeks
• Have had treatment with radium 223 before
• Have had a blood transfusion, or erythropoietin, in the past 4 weeks
• Have had another cancer in the past 5 years except non melanoma skin cancer or superficial bladder cancer that is low grade
• Have prostate cancer that has spread to other parts of the body, apart from the bones
• Have pressure on the nerves of your spine (spinal cord compression)
• Cannot control your bowels (faecal incontinence)
• Have any other medical condition that might affect you taking part in this trial

This is an international phase 3 trial. It will recruit about 900 men from different countries around the world. It is a randomised trial. The men taking part are put into 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in or told which group you are in. This is called a double blind trial.

Group 1 in this trial will have radium 223 plus best standard of care. Group 2 will have a dummy drug (placebo) plus best standard of care. Of all those entering the trial, 2 out of every 3 will be put in group 1, and so will have radium 223.

You have 6 treatments of radium 223, or placebo, every 4 weeks. You have the radium 223, or placebo, as an injection into a vein.

The researchers will ask you to fill in a questionnaire

• Before you start treatment
• 16 weeks after starting treatment
• At the end of treatment
• Every 2 months to 1 year
• Every 4 months to 3 years

It will ask you about how you are feeling and any symptoms that you have had. This is called a quality of life questionnaire.

You will see your doctor and have some tests before you take part in this trial.

These tests include

• Physical examination
• Blood tests including PSA
• Chest X-ray
• Heart trace (ECG)
• Bone scan
• CT scan of the tummy (abdomen) and area between your hip bones (pelvis)

You will have another examination and more blood tests every 4 weeks during treatment. Before the second treatment you will also have another heart trace (ECG).

At the end of treatment you will see the doctor and have

• Physical examination
• Blood tests
• Heart trace (ECG)

Every 2 months till 1 year after your treatment you will see the doctor and have a physical examination and blood tests.

Then every 4 months till 3 years after your treatment you will see the doctor and have a physical examination and blood tests.

All treatments can have side effects. The main side effects of radium 223 are

• Bowel problems
• Feeling sick (nausea and vomiting)
• Drop in blood cells causing an increase in risk of infection, bruising and bleeding problems
• Tiredness (fatigue)