A multi-centre, non-interventional study of relugolix in patients with advanced hormone-sensitive prostate cancer
This study, called RENAISSANCE, is observing how well a medicine named relugolix works for men with advanced hormone-sensitive prostate cancer. It’s an 'observational' study, meaning researchers don't ask you to take any new treatments or have extra tests. Instead, they simply collect information from your regular medical check-ups to see how relugolix performs in everyday care over about a year. You can join if you're a man aged 18 or over with this type of prostate cancer, and your doctor has decided relugolix is the best treatment option for you, and you're starting it for the first time. The study aims to learn more about relugolix's effectiveness and side effects to help future patients.
At a glance
What is this study about?
This study is called RENAISSANCE and it's looking at a medicine called relugolix, which is used to treat advanced hormone-sensitive prostate cancer. The main goal is to understand how well relugolix works and how patients get on with it in real-world everyday medical care. It's a very practical study, as it doesn't involve giving anyone new treatments or asking them to do anything different from what their doctor has already prescribed.
Imagine researchers watching how you get on with your usual treatment. That's essentially what they're doing here. They collect information from your existing medical records and routine doctor visits, such as test results, treatment details, and how your cancer changes over time. They also note any side effects. This helps them build a bigger picture of how relugolix performs when used by many different patients in various hospitals.
By gathering this real-life information, the study hopes to learn more about relugolix's effects and how it helps patients. This knowledge can be really valuable for doctors and patients in the future, helping them make informed decisions about prostate cancer treatment.
Key takeaways
- This study observes how relugolix works for prostate cancer in real life.
- Your treatment and medical care will not change if you participate.
- Researchers collect information from your existing medical records.
- You must be starting relugolix for the first time.
- The study aims to help future patients by improving understanding of relugolix's effects.
Who may be eligible?
You might be able to take part in this study if you are a man aged 18 or older and have been diagnosed with advanced hormone-sensitive prostate cancer. A key requirement is that your doctor has already decided that relugolix is the right treatment for you, and you are starting it for the very first time.
This study is not suitable if you have had an operation to remove your testicles (called surgical castration), have used relugolix before, or if your doctor expects you to take relugolix for less than twelve months. Also, you can't join if you have a known allergy to relugolix or any of its ingredients.
Crucially, you must be able to understand the study information and be willing to sign a consent form, which shows you agree to take part.
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.
- Am I a man, age 18 or older?
- Do I have advanced hormone-sensitive prostate cancer?
- Has my doctor decided relugolix is the right treatment for me?
- Am I starting relugolix for the very first time?
- Do I plan to take relugolix for at least 12 months?
- Have I NOT had surgery to remove my testicles?
What does participation involve?
If you decide to take part, your medical care and treatment will not change at all. You will continue to have all your usual clinic visits, tests, and check-ups exactly as planned by your doctor. The study doesn't ask you to make any extra appointments or have any additional procedures.
What happens is that the research team will collect information from your existing medical records for up to one year after you agree to join. This includes details about your health, test results, how your prostate cancer is being treated with relugolix, any side effects you experience, and how your condition changes over time. You simply continue with your regular care, and the researchers gather this information in the background.
Potential risks and benefits
Locations (3)
- Royal Cornwall Hospitals NHS TrustCity onlyTruro, England
- Northern Lincolnshire and Goole NHS Foundation TrustCity onlyGrimsby, England
- University Hospitals of Morecambe Bay NHS Foundation TrustCity onlyKendal, England
Common questions
What is relugolix?
Relugolix is a medicine used to treat advanced hormone-sensitive prostate cancer.
Will my treatment change if I join this study?
No, your treatment and all your medical care will stay exactly the same. You won't receive different medicines or have extra tests for the study.
What does 'observational study' mean?
It means the researchers are just watching and collecting information from your routine medical care. They aren't trying out new treatments or changing anything you do.
How long will I be in the study?
The researchers will collect information from your medical records for up to one year after you agree to participate.
Who is paying for this study?
The study is funded by a company called Accord Healthcare.
How to find out more
Brigitta Hunter
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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