CompletedInterventional

Radium-223: evaluation of activity and surrogate response

This clinical trial is for men whose prostate cancer has spread to their bones and is no longer responding well to standard hormone treatments. Radium-223 is a targeted radioactive medicine that travels directly to bones to attack cancer cells while limiting harm to healthy areas. In this study, doctors are testing two different doses of Radium-223: the standard dose and a higher dose. Patients will be put into one of two groups by chance to receive one of these doses. The main aim is to see how safe and effective the higher dose is compared to the standard dose. Researchers will also use regular blood tests and bone scans to see if certain markers can quickly tell doctors how well the treatment is working. This could help doctors tailor prostate cancer treatments more effectively in the future.

At a glance

Status

Completed

Enrolment target

Start

30 Jan 2015

Estimated completion

30 Jun 2017

Prostate cancer

What is this study about?

Prostate cancer is very common, and in some men, it can spread to other parts of the body. The bones are the most common place for it to spread. When the cancer continues to grow despite hormone therapy, it is known as advanced or castrate-resistant prostate cancer. Finding treatments that directly target cancer in the bones is important to help men live longer and reduce bone pain.

Radium-223 is a treatment that acts like calcium in the body. Because bones naturally absorb calcium, the medicine goes straight to the areas of bone where cancer cells are active. Once inside the bone, Radium-223 gives off tiny, powerful bursts of radiation. This damages the cancer cells while causing minimal harm to the healthy tissue around them.

This study, known as the REASURE trial, aims to answer two important questions. First, it compares the usual dose of Radium-223 with a higher dose to see if the higher dose works better at controlling the cancer. Second, researchers want to see if specific proteins and signals in the blood can act as early signs of whether the medicine is working.

By taking part, patients help doctors understand how to get the best results from Radium-223 and how to monitor future patients more clearly through routine blood checks.

Key takeaways

Tests whether a standard or higher dose of Radium-223 works better for bone-spread prostate cancer.
Aimed at men whose cancer is growing despite ongoing hormone treatment.
Radium-223 is given as an injection into a vein once every four weeks.
Involves regular blood tests and scans to monitor how the cancer responds.
Participation is voluntary, and you can stop at any time without losing NHS care.

Who may be eligible?

This trial is for men aged 16 and over who have prostate cancer that has spread to at least two spots in their bones. It is specifically for men whose cancer has started growing again even though they are taking hormone therapy, which is usually shown by rising PSA levels in blood tests.

To be eligible, you should be feeling reasonably well in your everyday life, meaning you can walk around and look after your basic daily needs. Your blood counts, liver, and kidneys also need to be working well enough to handle the treatment safely. The study team will run simple blood tests to confirm this before you can join.

You cannot take part if you have already had Radium-223 or similar radioactive treatments in the past. You will also not be able to join if you have recently had chemotherapy for advanced prostate cancer, or if you are planning to start chemotherapy within the next six months.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a man aged 16 or over.
I have prostate cancer that has spread to at least two areas in my bones.
My cancer is growing or my PSA levels are rising despite hormone treatment.
I have not previously had Radium-223 or other radioactive treatments.
I am well enough to look after myself and walk around for daily activities.
I have not recently had chemotherapy for this stage of prostate cancer.

Answer every question to see your result.

What does participation involve?

If you take part, you will be assigned by a computer to receive either the standard dose or a higher dose of Radium-223. You have an equal chance of being in either group. The medicine is given as a slow injection into a vein, usually once every four weeks for up to six injections in total.

Throughout the study, you will have regular clinic visits for check-ups. These visits will include blood tests to check your blood cell counts, liver function, and kidney function, as well as tracking cancer markers like PSA. You will also have bone scans to see how the cancer in your bones is responding to the treatment.

After your treatment finishes, the research team will continue to monitor your health with follow-up appointments. In total, being part of the study will involve several visits to the hospital over a period of at least six months, followed by long-term check-ins.

Potential risks and benefits

Taking part may help control the cancer in your bones, relieve bone pain, and help doctors learn more about the best dose for future patients. However, there is no guarantee that the treatment will benefit you directly. Radium-223 can cause side effects, such as tiredness, feeling sick, loose stools, or a drop in blood cell counts, which can increase the risk of infection or bruising. The study team will check you closely at every visit to manage any symptoms quickly. Joining is completely voluntary, and you are free to leave the trial at any time without it affecting your regular NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Institute for Cancer Research
City only
Sutton, England

Common questions

What is Radium-223 and how does it work?

Radium-223 is a radioactive liquid medicine that mimics calcium. It travels straight into areas of bone damaged by cancer and releases targeted radiation to destroy cancer cells from the inside.

Will I be radioactive or dangerous to my family?

The radiation travels only a fraction of a millimetre inside your body, so it does not easily pass through your skin. However, small amounts leave your body through urine and bowel movements, so the medical team will give you simple hygiene advice to follow at home.

Can I choose which dose of Radium-223 I receive?

No. A computer puts participants into one of the two dose groups by chance. This process is called randomisation and ensures the results of the trial are completely fair and unbiased.

How often will I need to visit the hospital?

You will usually receive an injection once every four weeks for up to six doses. You will also have visits for blood tests, health checks, and scans throughout this time.

What happens if I change my mind after starting?

You are completely free to leave the study at any point. Your decision will never affect the quality of your regular medical care or your relationship with your healthcare team.

How to find out more

Dalia Ismail

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.