A trial looking at Radium 223 (Alpharadin) for men with prostate cancer that has spread to the bones (ALSYMPCA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at combining radium 223 (Alpharadin) with best standard care to treat men whose prostate cancer has spread to their bones. This trial is recruiting men whose cancer is no longer responding to hormone therapy.
Doctors often treat prostate cancer with hormone therapy. Sometimes the hormones can stop working and the cancer can spread to the bones. Cancer that has spread to the bones can cause pain. To control the pain, doctors often start with painkillers. If these do not control the pain, they may use radiotherapy as well.
You can have radiotherapy internally to treat the cancer cells in causing pain in the bone. This is called a radioactive isotope (radioisotope). This radioactive substance targets cancer in the bones and gives off high energy. Doctors think radioisotopes stop cancer growing in the bones. This may help control bone pain.
Radium 223 (Alpharadin) is a new type of radioactive injection that gives off a different type of high energy than radioisotopes that are currently used. We know from research that radium 223 can target cancer cells in the bones better than radioisotopes.
The aims of this trial are to
- Find out if men having radium 223 with best standard care live longer than men having best standard care only
- Learn about the safety of radium 223 in men with prostate cancer that no longer responds to hormone therapy
Who can enter
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.
Location of trialCLOSED
For more information
Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.
Cancer Research UK
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