A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination with Other Anticancer Agents in Participants with Metastatic Prostate Cancer (ANDROMEDA)
This research study, called ANDROMEDA, is for men who have prostate cancer that has spread to other parts of their body. It's a two-part study (Phase I and Phase II) that's trying out a new medicine called AZD9750. Researchers want to know a few key things: Is AZD9750 safe to use? How does the body handle the drug? And does it help to slow down or shrink the cancer when used by itself or when combined with other cancer treatments? This is the first time this drug is being given to people, so understanding its safety and how well it works is very important for future cancer care.
At a glance
What is this study about?
This study is called ANDROMEDA, and it's looking into a new treatment for men with prostate cancer that has spread to other parts of the body. This type of cancer is called 'metastatic prostate cancer'. The main goal is to test a new drug called AZD9750. This drug will be given on its own to some patients, and to others, it will be given along with other existing cancer medicines.
The study has two main stages, called Phase I and Phase II. The first stage (Phase I) is mostly about making sure the new drug is safe and finding the right dose. Researchers will carefully watch for any side effects and see how the drug behaves in the body. The second stage (Phase II) will build on this. Here, they will continue to check for safety but also start to look more closely at whether the drug helps to shrink the cancer or slow its growth. They'll measure this by looking at blood tests (like PSA levels) and scans.
Finding new ways to treat metastatic prostate cancer is really important because it can be a challenging disease. Studies like ANDROMEDA help doctors understand if new drugs could offer better options for patients in the future. By joining, you'd be helping to advance medical knowledge and potentially help countless others with prostate cancer.
Key takeaways
- This study is for men with prostate cancer that has spread.
- It's testing a new drug called AZD9750, alone or with other treatments.
- Researchers want to understand its safety and how well it works.
- You'll have regular hospital visits for tests and monitoring.
- Your participation could help improve future cancer treatments.
Who may be eligible?
This study is looking for male volunteers, aged 18 years and older, who have prostate cancer that has spread to other parts of their body. There will be other health requirements that your doctor will check to make sure the study is a good fit for you.
To be considered for this study, you must have been diagnosed with prostate cancer that doctors have confirmed has spread. Your healthcare team will need to review your medical history and current health to make sure you meet all the necessary criteria.
It's important to remember that not everyone with metastatic prostate cancer will be able to join. There are specific rules to ensure the study is safe and that the results are reliable. Your doctor will discuss all these details with you.
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 male?
- Are you 18 years old or older?
- Have you been diagnosed with prostate cancer that has spread?
- Are you able to attend regular hospital visits for tests?
What does participation involve?
If you decide to join this study, you'll be given the study drug, AZD9750, either by itself or along with other cancer medicines. You'll have regular visits to the clinic where doctors and nurses will monitor your health very closely. These visits will involve blood tests to check how the drug is affecting your body and to measure your prostate specific antigen (PSA) levels. You will also have physical examinations, vital signs taken (like blood pressure and heart rate), and sometimes heart tracings (ECGs) and scans to see how your cancer is responding.
The study aims to understand the safety of the drug and how effective it is. The total time you'd be involved in the study will vary, but you would be monitored throughout the treatment period and potentially for a follow-up period afterwards. The research team will explain the exact schedule of visits and what each will involve if you are interested in taking part.
Potential risks and benefits
Locations (2)
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Common questions
What is prostate cancer that has 'spread'?
This means the cancer has grown outside the prostate gland and moved to other parts of the body, like the bones or lymph nodes. Doctors call this 'metastatic' cancer.
What does 'Phase I/II' mean?
This refers to the stage of the drug's development. Phase I checks mainly for safety and dosage, while Phase II looks more at how well the drug works, in addition to safety.
What is AZD9750?
AZD9750 is a new medicine being tested. It's designed to fight cancer, but doctors are still learning exactly how it works and how effective it is.
Will I definitely get the new drug?
Yes, if you join this study, you will receive AZD9750, either by itself or combined with other cancer treatments. This study does not use a placebo.
What is PSA and why is it measured?
PSA stands for Prostate Specific Antigen. It's a protein made by the prostate. High or rising PSA levels can indicate prostate cancer activity, so doctors measure it to see how the cancer is responding to treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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