Quantitative Unified Assessment of Novel Triplet therapy and Unconventional Maintenance with Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer: A Phase II Pilot Trial
This phase II clinical trial is exploring a targeted medicine called Radium-223 (brand name Xofigo) for people with advanced prostate cancer. This study focuses on cancer that has spread to the bones but still responds to hormone therapy. Radium-223 is given as a simple injection into a vein. It mimics calcium, allowing it to travel directly to active areas in the bones to attack cancer cells while causing minimal harm to healthy tissue. The main aim of this study is to see how well patients can tolerate and finish the planned course, aiming for at least five cycles of treatment. Researchers will also check whether the medicine helps lower cancer markers in the blood (such as PSA), reduces bone pain, prevents fractures, and improves everyday quality of life.
At a glance
What is this study about?
Prostate cancer is one of the most common cancers in the UK. In some cases, cancer cells travel outside the prostate gland and settle in other parts of the body, most often the bones. When the cancer still responds to standard hormone therapy, it is called hormone-sensitive prostate cancer. Finding gentle and effective ways to treat bone spread early is an important goal for researchers.
This trial focuses on a treatment called Radium-223 (Xofigo). Because the body treats radium like calcium, the medicine naturally flows straight to areas of bone where cancer is growing. Once there, it releases tiny bursts of radiation that destroy nearby cancer cells. Because the radiation travels only a fraction of a millimetre, it causes very little damage to the surrounding healthy tissues.
The main purpose of this study is to see how practical it is for patients to complete a full course of Radium-223. Doctors want to find out if patients can comfortably manage at least five cycles alongside their other treatments. They will also look closely at how the treatment affects pain levels, reduces the risk of broken bones, and supports overall well-being and daily living.
Key takeaways
- The trial tests Radium-223 injections for prostate cancer that has spread to the bones.
- The main goal is to see if patients can comfortably complete at least five doses.
- The treatment seeks out bone tumours directly to deliver targeted radiation.
- Doctors will measure changes in pain, bone strength, PSA levels, and everyday quality of life.
- Taking part is completely voluntary, and you can leave the study at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have advanced prostate cancer that has spread to their bones (known as high-volume metastatic disease). The cancer must still be responsive to hormone-blocking treatments.
To take part, you will need to have good enough general health to attend regular hospital appointments and receive intravenous injections. Your hospital team will perform blood tests to ensure your bone marrow, liver, and kidneys are working well enough for the medicine to be given safely.
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 18 years of age or older.
- I have been diagnosed with prostate cancer that has spread to my bones.
- My cancer is currently hormone-sensitive (responds to hormone treatments).
- I am well enough to attend regular hospital appointments for injections and blood tests.
What does participation involve?
If you decide to join this study, you will receive Radium-223 as a slow injection into a vein, usually given once every four weeks for up to six doses. Each injection appointment typically takes only a few minutes, but you will spend extra time at the hospital for check-ups.
During your visits, the research team will take routine blood samples to check your blood cell counts and monitor cancer markers like PSA. You will have regular scans to see how your bones are responding. You will also be asked to fill out short questionnaires about your energy levels, any pain you might feel, and your day-to-day quality of life. The total active treatment usually lasts around five to six months, followed by regular check-ins to monitor your health.
Potential risks and benefits
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Common questions
What is Radium-223 and how does it work?
Radium-223 is a targeted radioactive liquid. It behaves like calcium in your body, meaning it travels directly into the bones to deliver radiation straight to cancer cells.
Will I be radioactive to family and friends?
The radiation travels only a tiny distance inside your body. It is safe to be around loved ones, but your team will give you simple hygiene tips, such as washing your hands well and flushing the toilet twice for a few days after each dose.
Do I have to stop my standard hormone therapy?
No. In this trial, Radium-223 is typically added alongside your existing hormone treatments to give extra support against bone tumours.
What happens if I cannot manage all five doses?
Your safety is always the top priority. If side effects become difficult, your doctor can pause or stop the treatment early and switch you back to standard care.
Do I have to pay for the trial treatment?
No. The trial medicine and any extra study tests are provided free of charge, and you may be able to get help with travel costs to the hospital.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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