Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC)
This research trial is for men with prostate cancer that has spread only to their bones and is resistant to hormone treatment. We want to find the best way to give two important medicines: Radium-223 (often called Xofigo) and Docetaxel (a type of chemotherapy). The study will look at giving these treatments in different orders to see which sequence is most effective. Our main goal is to improve how patients feel, especially regarding pain from bone metastases and their overall quality of life. We'll also be checking how long people stay well, how long they live, and looking for signs in the blood that might predict how well treatments work. Participants will be carefully monitored throughout the study.
At a glance
What is this study about?
This study is for men who have prostate cancer that has spread to their bones, but not to other parts of their body. Importantly, the cancer must also be 'castration-resistant', which means it's no longer responding to treatments that lower testosterone levels. Many men in this situation experience pain, so improving their comfort and overall well-being is a key focus.
We are looking at two established treatments: Radium-223 (also known as Xofigo), which is a targeted radiation treatment for bone metastases, and Docetaxel, a type of chemotherapy. Both are routinely used, but we don't fully know the best order to give them. This trial aims to compare giving one treatment first and then the other, versus giving the other treatment first. We hope to discover which sequence works best for managing pain and improving a patient's daily life.
Ultimately, the goal is to make sure men with this type of prostate cancer receive the most effective treatment plan, leading to a better quality of life and potentially longer disease control. By carefully comparing these different approaches, we hope to provide doctors with clearer guidelines on how to best use these important medicines.
Key takeaways
- Compares two existing prostate cancer treatments: Radium-223 and Docetaxel.
- Studies the best order to give these treatments for prostate cancer spread to bones.
- Aims to improve pain control and overall quality of life.
- Involves regular assessments, including questionnaires and blood tests.
- Participants will receive both treatments, just in different sequences.
- Aims to gather insights to help future patients.
Who may be eligible?
This study is specifically designed for men aged 18 or older.
To be considered, you must have prostate cancer that has spread to your bones. Crucially, the cancer should not have spread to other organs like the liver or lungs. Your cancer also needs to be 'castration-resistant,' meaning it's no longer responding to hormone-lowering treatments.
There are other medical criteria that your doctor will check to make sure the study is right for you and that you can safely participate.
- Am I a man?
- Am I 18 years old or older?
- Do I have prostate cancer that has spread only to my bones?
- Is my prostate cancer no longer responding to hormone treatments?
- Am I currently experiencing symptoms from my bone metastases (like pain)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be assigned to one of two groups by chance (like flipping a coin). Both groups will receive Radium-223 and Docetaxel, but in a different order. You will also receive steroid medications like prednisone or dexamethasone, which are common treatments given alongside these therapies.
Throughout the study, you'll have regular visits to the hospital or clinic. At these visits, you'll have blood tests, physical examinations, and answer questionnaires about your pain levels and how you're feeling overall. These questionnaires are important for us to understand the impact of the treatments on your daily life. You'll have assessments before starting treatment, during each treatment cycle, at the end of treatment, and then at follow-up visits after the treatment period has finished. These follow-up visits help us see the longer-term effects of the treatments. The total duration of your participation will depend on your specific treatment plan and how long your doctor feels it is beneficial for you to be followed.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is 'castration-resistant' prostate cancer?
This means your prostate cancer is growing even though treatments are lowering your testosterone levels. It's a common stage of the disease.
Why are you looking at the order of treatments?
Both Radium-223 and Docetaxel are good treatments. We want to find out if giving one before the other makes a difference in how well they work and how you feel.
What kind of questionnaires will I fill out?
They are simple questions about your pain levels and how your cancer is affecting your daily life. Your honest answers are very important for the study.
Will I definitely get these treatments if I join?
Yes, if you join, you will receive both Radium-223 and Docetaxel, along with steroid medications, as part of the study plan.
What is the overall goal of this study?
The main goal is to find the best way to use these existing treatments to improve the quality of life and manage pain for men whose prostate cancer has spread only to their bones.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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