A study adding radiotherapy and radionuclide therapy to hormone therapy to slow the spread of prostate cancer (ADRRAD)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 1/2

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

The standard treatment Open a glossary item for prostate cancer that has spread is hormone therapy. This can control the cancer for some time. When the cancer stops responding doctors can use other treatments. 

Another treatment they might use is radium 223. Radium 223 is a radioactive Open a glossary item liquid. It is injected into a vein and circulates throughout the body. It particularly targets prostate cancer that has spread to the bones. 

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 clinical trial Open a glossary item with a large number of men.

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 Open a glossary item

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 scan Open a glossary item that shows your cancer has spread to organs of the body such as the liver or lungs 
  • Have already had radium 223 or another radionuclide therapy Open a glossary item such as strontium 89 
  • Have had radiotherapy Open a glossary item to a quarter (25%) or more of your bone marrow Open a glossary item 
  • 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 immune system Open a glossary item
  • 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 Open a glossary item
  • Have or might have spinal cord compression Open a glossary item
  • 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

Trial design

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 goserelin Open a glossary item, as an injection. You can have it once a month or one every 3 months. You continue to have your hormone therapy throughout the study.

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 biopsy. Open a glossary item They will also ask for some extra blood samples, urine samples and bone marrow Open a glossary item samples. They will use these samples to find out more about prostate cancer. You don’t have to agree to give these samples for research. You can still take part in the trial.  

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.

Hospital visits

You see the doctor to have some tests before taking part. These tests include

Your doctor will ask you to have a bone marrow test. You don’t have to have this if you don’t want to. It is up to you. 

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.

Side effects

The most common side effects of external radiotherapy are

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
  • diarrhoea 

We have more information about 

We have information about the side effects of hormone therapy for prostate cancer.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13917

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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