"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study adding radiotherapy and radionuclide therapy to hormone therapy to slow the spread of prostate cancer (ADRRAD)
This study is adding external radiotherapy and radium 223 to hormone therapy to stop prostate cancer from spreading further in the bones. This study is open to men whose prostate cancer has already spread to the bones when diagnosed.
More about this trial
Another treatment they might use is radium 223. Radium 223 is a
When the cancer has already spread to the bones doctors don’t currently give external radiotherapy to the prostate. But they might use it to treat bone pain caused by the cancer.
We know from research in other cancer types that treatment to where the cancer started could help to slow down the cancer getting worse.
Researchers think that starting external radiotherapy to the prostate and radium 223 at the same time as hormone therapy could slow down the spread of prostate cancer in the bones. To find this out they need to do a
But these 3 treatments aren’t usually given at the same time. They need to find out how acceptable it is to give these treatments at the same time. So before doing a large clinical trial they will do a small feasibility study to find out
- how safe it is to give hormone therapy, external radiotherapy and radium 223 at the same time
- what the side effects are
- how this combination of treatments affects
quality of life
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have had a bone scan that shows 3 or more areas of cancer in your bones
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable barrier contraception or not have sex during treatment and for 6 months afterwards. Men who have had a vasectomy must also agree to this
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Have had a
CT scanthat shows your cancer has spread to organs of the body such as the liver or lungs
- Have already had radium 223 or another
radionuclide therapysuch as strontium 89
- Have had
radiotherapyto a quarter (25%) or more of your bone marrow
- Have had a bone marrow transplant using your own cells (autologous transplant) or stem cell rescue within 4 months of joining this trial
- Have had an organ transplant and are taking drugs that affects your
- Have had an experimental drug in the past 4 weeks or are planned to have an experimental drug while taking part in this trial
- Have had G-CSF within 3 weeks of joining this trial
- Have had another cancer in the past 5 years apart from successfully treated
basal cell skin cancer
- Have or might have
spinal cord compression
- Have an infection that isn’t been controlled with medication
- Have any other serious medical conditions or mental health problems that the researchers think could affect you taking part
This is a phase 1/2 trial. The researchers need 30 men who are going to the Northern Ireland Cancer Centre, Belfast to join.
You have hormone therapy for at least 3 months before starting external radiotherapy and radium 223.
After 3 months as long as your PSA is falling you can continue hormone therapy. You can have it for up to a year before starting radiotherapy and radium 223.
Your GP will give you your hormone therapy, such as
When your PSA blood test result is 5ng/ml or less you start external radiotherapy and radium 223.
You have external radiotherapy every day Monday to Friday for 7½ weeks. Before starting you have an appointment at the hospital to plan the radiotherapy.
You have radium 223 as an injection into a vein. You have it once a month for 6 months.
Blood and tissue samples
The researchers will ask for a sample of your cancer that was removed when you had a
Quality of life study
The trial team will ask you to fill out a questionnaire
- before you start external radiotherapy
- every 4 weeks while having radium 223
- 8 weeks after finishing radium 223
- 6 months after finishing radium 223
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor to have some tests before taking part. These tests include
Before starting external radiotherapy you go to the hospital for a CT scan planning appointment. During external radiotherapy treatment you see the doctor every week.
Before every treatment with radium 223 you see the doctor for blood tests and to see how you are.
After finishing radium 223 you see the doctor at 2 months and 6 months for
- A physical examination
- Blood tests
- MRI scan
Your doctor will then tell you how often they want to see you.
The most common side effects of external radiotherapy are
- inflammation of the bladder (cystitis) causing a need to pass urine more often and burning when passing urine
- irritation of the back passage (proctitis) causing soreness around the back passage and discomfort on opening bowels
- opening the bowels more frequently
- loss of sexual function (impotency)
- skin redness at treatment area
- loss of pubic hair
The most common side effects of radium 223 are
- a drop in blood cells causing an increased risk of infection, bleeding, tiredness and shortness of breath
- feeling or being sick
We have more information about
We have information about the side effects of hormone therapy for prostate cancer.
How to join a clinical trial
Professor Joe O’Sullivan
Belfast Health & Social Care Trust
Experimental Cancer Medicine Centre (ECMC)
Prostate Cancer UK
Queen's University Belfast
Friends of The Cancer Centre
University of Manchester