A study adding radiotherapy and radionuclide therapy to hormone therapy to slow the spread of prostate cancer (ADRRAD)
Cancer type:
Status:
Phase:
This study added external radiotherapy and radium 223 to hormone therapy to stop prostate cancer from spreading further in the bones. It was open to men whose prostate cancer had already spread to the bones when diagnosed.
This study was open for people to join between 2016 and 2019. The team published the results in 2021.
More about this trial
The 
for prostate cancer that has spread is hormone therapy. This can control the cancer for some time. When this treatment stops working, doctors can use other treatments.
They might use radium 223. Radium 223 is a liquid. You have it as an injection into your vein. It then goes throughout the body. Radium 223 particularly targets prostate cancer that has spread to the bones.
When cancer had already spread to the bones, doctors don’t usually treat the prostate with external radiotherapy. 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 thought that having all 3 treatments at the same time could slow down the spread of prostate cancer in the bones. To find this out they needed to do a with a large number of men.
These 3 treatments aren’t usually given at the same time. First the researchers needed to find out how acceptable it is to have these treatments at the same time. So before doing a large clinical trial, they did a small feasibility study.
The aims were 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
Summary of results
The team found the combination of all 3 treatments:
- was well tolerated
- had acceptable side effects
- had an acceptable impact on quality of life
Study design
This was a phase 1/2 study. 30 men took part. Everyone had:
- continuous hormone therapy
- 6
cycles of treatment (6 months) of radium 223 - 7½ weeks of external radiotherapy
Results
Side effects
The team looked at the side effects during the 6 cycles of radium 223 and at 8 weeks after finishing it. Most of the side effects were mild to moderate. They found that:
- 25 men had diarrhoea
- 17 men had difficulty passing urine
- 1 man had a urinary infection. This was successfully treated with antibiotics.
- 3 men had a drop in their
white blood cells - 1 man had a drop in his white blood cells and
platelets
They also looked at the side effects 6 months after finishing radium 223. Overall the most common side effects that men reported were:
- tiredness and lack of energy
- diarrhoea
- difficulty passing urine
- waking up a number of times during the night to pass urine
- needing to pass urine more often
- tummy (abdominal) pain
- feeling or being sick
- a drop in blood cells
- hot flushes
- painful muscle and joints
Quality of life
The men filled in quality of life questionnaires:
- before starting treatment
- every 4 weeks while having radium 223
- 8 weeks after finishing radium 223 treatment
- then 6 months later
They found that during radium 223 treatment men reported more problems with their bowels and passing urine. This had an impact on their quality of life.
By the end of the study these problems had resolved. And there was no difference between their quality of life before starting radium 223.
How well the treatment worked
When treatment for all men had finished, the study team looked at how many men had cancer in their bones that was either:
- the same (stable), or
- had reduced
The team found it was 24 of the 30 men. By the end of the trial 17 men still had either stable cancer or less cancer in their bones.
The team looked at how long it was before the cancer started to grow again. Half the people’s cancer got worse 20 1/2 months after joining the trial.
Conclusion
The team concluded that adding radium 223 with radiotherapy and hormone therapy has:
- acceptable side effects and
- an acceptable impact on the quality of life
Researchers need to do a to find out how well this combination works.
The team are also doing further research to find out how this treatment benefits the patient.
More detailed information
There is more information about this research in the reference below.
P G Turner and others
Clinical Cancer Research, 2021. Volume 27, issue 16, pages 4549 to 4556.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Joe O’Sullivan
Supported by
Bayer
Belfast Health & Social Care Trust
Experimental Cancer Medicine Centre (ECMC)
Movember Foundation
Prostate Cancer UK
Queen's University Belfast
Friends of The Cancer Centre
University of Manchester
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Last reviewed:
Dangoor Education since 2010.
