A trial to examine the biological effects of Saruparib (AZD5305) alone, Darolutamide alone, and in combination in patients with newly diagnosed prostate cancer due to have radical prostatectomy.
This study is for men who have recently found out they have prostate cancer and are planning to have surgery to remove their prostate. Researchers want to understand how two different medicines, Saruparib (a new drug) and Darolutamide (an existing drug), affect prostate cancer. They are testing each drug on its own, as well as giving them together, to see if they can reduce the cancer or change it in a helpful way before surgery. This is an early-stage study, which means it's one of the first times these drugs are being looked at in this specific situation, to learn more about how they work in the body.
At a glance
What is this study about?
This research study is about finding new ways to treat prostate cancer. If you've recently been diagnosed with prostate cancer and are scheduled to have an operation called a radical prostatectomy (which means removing your prostate gland), this study might be relevant to you. The main goal is to understand how two particular medicines affect prostate cancer.
Researchers are using a new drug called Saruparib, and another drug called Darolutamide, which is already used for some types of prostate cancer. They want to see what happens when patients take Saruparib on its own, Darolutamide on its own, or both drugs together, before their surgery. By carefully studying the prostate tissue after it's removed during surgery, they hope to learn how these drugs change the cancer at a biological level.
The information gathered from this study is really important. It could help doctors understand if these drugs could be a useful way to treat prostate cancer in the future, possibly making surgery more effective or even reducing the size of the cancer before the operation. This is also a 'Phase I' study, which means it's an early step in testing new treatments, focusing on how the drugs work and how safe they are.
Key takeaways
- This study evaluates new ways to treat prostate cancer before surgery.
- It tests Saruparib and Darolutamide drugs, alone and in combination.
- The primary goal is to understand how these drugs affect the cancer at a biological level.
- It's for men recently diagnosed with prostate cancer who are having prostate removal surgery.
- Participants will take study drugs and have close medical monitoring.
Who may be eligible?
This study is designed for men who have recently been diagnosed with prostate cancer. This means your doctors have confirmed you have prostate cancer and you are still in the early stages of planning your treatment.
To be considered for this study, you must be planning to have an operation called a radical prostatectomy. This is a common surgery to remove the prostate gland when prostate cancer is found.
Generally, you need to be at least 18 years old to take part. The study is open to men of all ages above 18, provided they meet the other specific health requirements that the doctors will check.
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 who has recently been diagnosed with prostate cancer.
- My doctors have recommended that I have an operation to remove my prostate gland.
- I am 18 years old or older.
- I am generally well enough to take part in a research study.
What does participation involve?
If you decide to take part, you would attend several appointments before your prostate surgery. This would involve medical checks, blood tests, and possibly other tests to understand your health and your prostate cancer. You would be given either Saruparib, Darolutamide, or both drugs to take for a set period before your planned surgery. Details on how often you take the medication and for how long will be fully explained.
During this time, you would have regular check-ups to monitor your health and how you are responding to the medication. After your surgery, the doctors will carefully examine your prostate tissue. There will also be some follow-up appointments after your surgery to see how you are doing and to collect more information. The total duration of your active participation will depend on the study schedule, which the research team will explain fully.
Potential risks and benefits
Locations (2)
- —UnverifiedNetherlands
- —UnverifiedSpain
Common questions
What is Saruparib?
Saruparib is a new drug being tested in this study to see how it affects prostate cancer.
What is Darolutamide?
Darolutamide is a medicine already used for some types of prostate cancer, and it's being tested here in a new way before surgery.
Will I know which drug I am taking?
The research team will explain exactly how the study is set up and if you will know which treatment you are receiving.
Does taking part affect my surgery date?
The study involves taking medication before your planned surgery, so it might slightly change your overall timeline. This will be discussed in detail.
What if I feel unwell during the study?
You will have a medical team closely monitoring you, and you should report any health changes or concerns immediately.
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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