Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate)
This research study, called ChemSABR Prostate, is designed for men who have prostate cancer that has continued to grow despite standard hormone therapy and chemotherapy like taxanes. It's looking at a new treatment plan that combines two chemotherapy medicines, vinorelbine and cisplatin, with a very precise type of radiation therapy called SABR. The first part of the study focuses on making sure this combination is safe. If it is, the next part will look at how well it prevents the cancer from growing or spreading. Participants will receive these treatments, and doctors will carefully monitor their health and the cancer's response. This research aims to find better ways to treat this type of prostate cancer.
At a glance
What is this study about?
This study is for men with prostate cancer that has become more difficult to treat. Usually, prostate cancer is treated with hormone therapy and sometimes chemotherapy. However, for some men, the cancer can keep growing even after these treatments. This is called ‘castration-resistant’ and ‘taxane-resistant’ prostate cancer, meaning it's no longer responding to certain common therapies.
The researchers in this study are exploring a new two-step approach. First, they will give two chemotherapy drugs, vinorelbine and cisplatin, which are designed to fight cancer cells. After this, they will use a special type of radiation therapy called Stereotactic Ablative Radiotherapy (SABR). SABR is a very precise way to deliver high doses of radiation directly to the cancer, aiming to destroy it while protecting healthy surrounding tissue. The combination of chemotherapy and SABR is hoped to be more effective than current treatments for this challenging type of prostate cancer.
The study has two main goals. The first goal, in 'Phase I', is to make sure this new treatment combination is safe for patients. Doctors will carefully watch for any side effects and see if the body tolerates the treatment well. If the treatment is found to be safe, the study will move to 'Phase II'. In this second part, the main goal is to see how well the treatment works in stopping the cancer from growing or spreading for a period of time. This research is important because it could lead to new and better treatment options for men with advanced prostate cancer.
Key takeaways
- This study tests a new treatment for difficult-to-treat prostate cancer.
- It combines two chemotherapy drugs with a special, precise radiation therapy (SABR).
- Initially, the study focuses on ensuring the new treatment is safe.
- Later, it will assess how well it stops the cancer from growing.
- This research hopes to find better ways to treat advanced prostate cancer.
Who may be eligible?
To be able to take part in this study, you must be a man aged 18 or over. This study is specifically for men whose prostate cancer isn't getting better with the usual treatments, like hormone therapy and standard taxane chemotherapy.
There will be other health checks to make sure this treatment is suitable for you and that you are healthy enough to receive it. For example, doctors will need to ensure your kidneys, liver, and other major organs are working well and that your general health allows you to undergo chemotherapy and radiation.
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.
- Are you a man aged 18 or older?
- Has your prostate cancer gotten worse despite hormone therapy?
- Has your prostate cancer gotten worse despite chemotherapy (like taxanes)?
- Are you able to travel to study appointments?
What does participation involve?
If you decide to join this study, you will first undergo several checks and tests to make sure it's the right treatment for you. If you are eligible, you will receive the chemotherapy drugs vinorelbine and cisplatin, followed by the special SABR radiation therapy. The treatments will involve regular visits to the hospital for infusions and radiation sessions. Doctors will monitor your health closely throughout this period, using blood tests, scans, and physical examinations to check how you're responding and for any side effects.
After your treatment is complete, you will have follow-up appointments to track your progress and long-term health. The total time you'll be involved in the study, from initial tests through treatment and follow-up, will depend on your individual response and the study's design. The study is designed to explore safety first, and then how well the treatment works.
Potential risks and benefits
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Common questions
What type of prostate cancer is this study for?
This study is for men whose prostate cancer has continued to grow even after receiving hormone therapy and standard chemotherapy treatments.
What are vinorelbine and cisplatin?
These are two different chemotherapy medicines that work by attacking and killing cancer cells in the body.
What is SABR?
SABR is a very precise type of radiation therapy that can deliver a high dose of radiation directly to the cancer with great accuracy.
What is the main goal of the first part of the study?
The main goal of the first part of the study is to check if this new combination of chemotherapy and radiation is safe for patients.
Can I stop participating in the study if I want to?
Yes, you can choose to stop participating in the study at any time without it affecting your medical care.
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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