Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

This research study is investigating a new medication called AZD5305 when given alongside common hormone therapies for prostate cancer that has spread to other parts of the body. The main goals are to check the safety of this new combination, see how well patients can tolerate it, and understand how the body uses and gets rid of the drugs. Researchers will also look for early signs of how effective the combination might be in treating the cancer. The study is split into two parts: one to find the right dose and another to confirm the findings in more patients. This work is important for potentially finding better ways to treat advanced prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

174

Start

02 Jun 2022

Estimated completion

11 Apr 2031

Metastatic Prostate Cancer

What is this study about?

This study is focusing on men who have prostate cancer that has spread to other parts of their body, also known as metastatic prostate cancer. Doctors are looking at a new drug, AZD5305, and how it works when combined with other hormone treatments that are already used for this type of cancer. The main aim is to understand if this new combination is safe for patients, how well they tolerate it, and how their bodies handle the drugs. They also want to see if there are any early signs that this combination could be an effective way to treat the cancer.

The study is happening in two main stages. The first stage, ‘Part A,’ is designed to help doctors find the right amount of the new drug (AZD5305) to give. This part will include men whose prostate cancer has either stopped responding to standard hormone therapy (called castration-resistant) or is still responding but has spread (called castration-sensitive). The second stage, ‘Part B,’ will then look at more men whose prostate cancer is castration-sensitive and has spread. This stage will help confirm the safety findings and get more information on whether the combination treatment helps shrink or control the cancer.

Combined, around 783 men will take part in this research. The treatment will continue for as long as it is helping to control the cancer, or until side effects become too much, or if the patient decides they no longer want to participate. This type of research is crucial for developing potentially better treatments for advanced prostate cancer in the future.

Key takeaways

The study is testing a new drug (AZD5305) with current hormone therapies for advanced prostate cancer.
It aims to check if the combination is safe and works well for patients.
Participation involves taking study medications and having regular check-ups.
The study includes men whose prostate cancer has spread.
You can stop participating at any time if you choose to.

Who may be eligible?

To join this study, you need to be a man aged 18 or older with prostate cancer that has spread. Your doctors must have confirmed this with tests. You should also be suitable for treatment with common hormone therapies like enzalutamide, abiraterone acetate, darolutamide, or apalutamide. It's important that your body's organs and bone marrow are working well, and you should be able to do your daily activities without much difficulty.

There are certain things that would mean you can't join the study. For example, if you've already had certain treatments like particular hormone agents for some parts of the study, or specific chemotherapy or radiation treatments. Also, if you're taking certain other medications or herbal supplements that could interfere with the study drugs, you might not be able to participate. Your study doctor will review all your medical history and current medications carefully to see if you are a good fit for the study.

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?
Do you have prostate cancer that has spread to other parts of your body?
Are you currently on, or suitable for, hormone-blocking treatments like enzalutamide or abiraterone?
Do you have good overall health and organ function?
Have you *not* had certain specific cancer treatments in the past (e.g., platinum chemotherapy, radiation in the mCSPC setting, or certain hormone agents for specific parts of the study)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the new drug AZD5305 along with one of the standard hormone therapies. You will have regular visits to the clinic for medical check-ups, blood tests, and to make sure you are feeling okay. These visits will also track how your cancer is responding to the treatment. You will continue taking the study medication until your cancer gets worse, if the side effects are too strong, or if you decide you no longer wish to continue. The total duration of your participation will vary depending on how the treatment works for you and how long you are able to continue taking it.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new combination treatment helps your cancer more than existing treatments. However, it's also possible that the treatment may not work for you, or you might experience side effects from the medications, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
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Detroit, United States
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Detroit, United States
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Syracuse, United States
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Myrtle Beach, United States
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Houston, United States
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Houston, United States
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Camperdown, Australia
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Darlinghurst, Australia
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East Melbourne, Australia
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Heidelberg, Australia
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Melbourne, Australia
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St Leonards, Australia

Common questions

What is metastatic prostate cancer?

This means your prostate cancer has spread from the prostate gland to other parts of your body.

What are new hormonal agents (NHAs)?

These are common medicines like enzalutamide, abiraterone, darolutamide, and apalutamide that are used to treat prostate cancer by affecting hormones.

What does 'castration-resistant' or 'castration-sensitive' mean?

It describes whether your prostate cancer is still responding to treatments that lower male hormones, or if it has started growing again despite these treatments.

Why do I need to be 'surgically or medically castrated'?

This means that your male hormone levels (testosterone) need to be very low, either from an operation or medication, as these hormones can fuel prostate cancer growth.

What if I decide I don't want to continue in the study?

You can leave the study at any time, for any reason, and it won't affect your future medical care.