A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
This study is investigating a new experimental treatment called AZD6621 for adult men who have prostate cancer that has spread to other parts of the body (metastatic prostate cancer). The main goals are to understand how safe AZD6621 is, if it helps to treat the cancer, and how the body handles the drug over time. The study is split into stages: an early stage (Phase 1) to find the best and safest dose, and then a later stage (Phase 2) where more people will test that dose. Different ways of giving the treatment will also be explored.
At a glance
What is this study about?
Imagine your doctor tells you that your prostate cancer has spread to other parts of your body, and current treatments aren't working as well as hoped. This can be a worrying time. That's why researchers are constantly looking for new ways to fight cancer.
This study is focusing on a new potential medication called AZD6621. Think of it like a new key that researchers hope can unlock a better way to treat advanced prostate cancer. The main purpose of this study is to carefully investigate this new key: how safe is it for people to take, does it actually help against the cancer, and how does it behave once it's in the body? This information is really important for developing new treatments.
The study is happening in stages. Initially, a small group of participants will receive different doses of AZD6621 to find out which dose is the safest and causes the fewest side effects. This is a crucial step to make sure future participants are given a dose that is both effective and manageable. Once safe doses are identified, a larger group of participants will then try these specific doses to further understand how well the treatment works and to gather more information on its safety. Different ways of giving the treatment will also be tested.
Key takeaways
- This study is testing a new drug called AZD6621 for men with advanced prostate cancer.
- It aims to understand the safety, side effects, and effectiveness of this new treatment.
- You must be an adult male with prostate cancer that has spread and worsened despite standard treatments.
- Participation involves regular hospital visits for checks and scans.
- You have the right to leave the study at any time.
- This is an 'open-label' study, meaning you will know you are receiving the experimental drug.
Who may be eligible?
This study is looking for men who have prostate cancer that has spread to other parts of their body, even after some other treatments. Your cancer must be a specific type called 'adenocarcinoma' and you must be at least 18 years old.
Your testosterone levels need to be low, either because you've had an operation to remove your testicles or you're already taking medication that lowers testosterone. Importantly, your prostate cancer must have started growing again despite these treatments. We'll also need a recent sample of your tumour tissue, either a fresh one or one that was taken previously.
Doctors will also need to see that your cancer has actually progressed recently, either by looking at blood tests (like PSA levels) or by scans that show new or growing tumours. The specific treatments you've had before might also play a role in whether you can join, depending on which part of the study you might be considered for.
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 an adult male?
- Do you have prostate cancer that has spread to other parts of your body?
- Has your prostate cancer continued to grow despite treatments like hormone therapy, which lower testosterone?
- Are your testosterone levels currently low?
- Do you have a recent sample of your tumour tissue available?
- Have scans or blood tests shown your cancer has progressed recently?
What does participation involve?
Taking part in this study means you'll receive the experimental drug AZD6621. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. These assessments will help the study team understand how the drug is working in your body and to keep you safe. The total length of your participation will depend on which part of the study you are in and how you respond to the treatment, but it will involve ongoing check-ups for a period of time.
Potential risks and benefits
Locations (25)
- Research SiteVerified postcodeOrlando, United States· Not yet recruiting
- Research SiteVerified postcodeTampa, United States· Recruiting
- Research SiteVerified postcodeBoston, United States· Withdrawn
- Research SiteVerified postcodeGrand Rapids, United States· Recruiting
- Research SiteVerified postcodeCommack, United States· Recruiting
- Research SiteVerified postcodeProvidence, United States· Recruiting
- Research SiteVerified postcodeGhent, Belgium· Not yet recruiting
- Research SiteVerified postcodeToronto, Canada· Not yet recruiting
- Research SiteVerified postcodeQuébec, Canada· Not yet recruiting
- Research SiteVerified postcodeBeijing, China· Not yet recruiting
- Research SiteVerified postcodeChengdu, China· Suspended
- Research SiteVerified postcodeGuangzhou, China· Suspended
Common questions
What is metastatic prostate cancer?
This means your prostate cancer has spread from your prostate gland to other parts of your body.
What does 'experimental treatment' mean?
It means AZD6621 is a new drug being tested, and doctors are still learning about how it works and whether it can help people.
Will I know if I'm getting the actual drug?
Yes, in this study, everyone taking part will receive the AZD6621 treatment. There is no 'placebo' or dummy treatment.
How long will I be in the study?
The exact length varies. You will have regular visits for check-ups, and scans, for as long as the treatment is helping and it's safe for you to continue.
What does 'Phase 1/2' mean?
Phase 1 is about finding the safest dose. Phase 2 then tests that dose in more people to see how well it works and to gather more safety information.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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