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Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer

This research trial is for men with prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy (called metastatic castration-resistant prostate cancer). The main goal is to test several new anti-cancer drugs, either alone or in combination, to see if they are safe and effective. Researchers will look at how the body handles these drugs, any side effects they might cause, and if they help shrink the cancer or slow its growth. This is a multi-part study, starting with finding the right dose and then expanding to see how well the chosen doses work. One part of the study specifically compares a new drug combination with a standard chemotherapy treatment.

At a glance

Status
Not yet recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
152
Start
14 May 2026
Estimated completion
05 Sep 2029

What is this study about?

This study is a clinical trial exploring new treatments for men with advanced prostate cancer. This type of prostate cancer has spread to other parts of the body (metastatic) and has become resistant to hormone therapy, meaning hormone treatments are no longer effective at controlling it. This trial aims to find better ways to treat this challenging form of cancer.

The researchers will be testing several new anti-cancer medicines. They want to understand a few key things about these drugs: how safe they are to use, any side effects they might cause, how the body absorbs and processes them, and if they show promise in stopping or slowing the cancer's growth. The study is designed in stages. First, a small group of participants will help doctors figure out the best dose of the new medicines that is both safe and has anti-cancer effects. Once the right dose is found, more participants will take part to further confirm these findings and gather more information on how well the treatment works.

One specific part of the study will thoroughly compare a new combination of medicines (called AZD2265 and AZD9574) against AZD2265 on its own, and also against a standard chemotherapy treatment called Docetaxel. The overall goal is to identify new and effective treatment options that could eventually benefit many more patients with advanced prostate cancer.

Key takeaways

  • This study is testing new treatments for advanced prostate cancer that has spread and is resistant to hormone therapy.
  • It aims to find safe doses and see how well these new drugs work.
  • You might receive new drugs, alone or in combination, or standard chemotherapy.
  • Regular hospital visits, tests, and scans are part of participating.
  • You could gain early access to new treatments, but there are potential side effects.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for men aged 18 to 99 who have advanced prostate cancer that has spread and is resistant to hormone treatment. You must have been previously treated with at least one type of hormone-blocking medicine, such as enzalutamide or abiraterone, and your cancer must have continued to grow despite this treatment.

It's important that you are generally well enough to take part, meaning you can look after yourself and manage daily activities, and doctors expect you to live for at least three more months. Your body's organs, like your liver, kidneys, and bone marrow, need to be working well. The cancer should also be visible on scans, and you must have some areas where the cancer has spread that cannot be surgically removed.

For a specific part of the study, your cancer will need to show up on special scans that detect a particular marker called PSMA, with all treatable cancer spots being PSMA positive. You also need to be able to take medicines by mouth, if required.

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.

  1. Are you a man, aged 18 to 99?
  2. Do you have prostate cancer that has spread and is resistant to hormone treatment?
  3. Have you previously received at least one hormone-blocking medicine for prostate cancer?
  4. Are you generally well and able to manage daily activities?
  5. Are your major organs (like liver, kidneys) working well?
  6. Do you have cancer that can be seen on scans but cannot be surgically removed?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of the new study medicines, either alone or in combination, or standard chemotherapy, depending on which part of the study you are in. You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Doctors will carefully watch for any side effects and adjust your care as needed.

The study involves different phases: an initial phase to find the safest and most effective dose, followed by a phase to further confirm these findings and gather more information on the treatment's effect. The exact number of visits, tests, and total duration will depend on which treatment you receive and how your body responds; this will be fully explained before you decide to join. If you are sexually active and your partner could become pregnant, you will need to use contraception.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to new and innovative treatments for your prostate cancer before they are widely available. However, there's no guarantee the treatment will work for you, and like all medicines, these drugs can have side effects, some of which may be serious. The research team will closely monitor you and explain any potential risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (33)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Encino, United States
  • Research Site
    Verified postcode
    South Pasadena, United States
  • Research Site
    Verified postcode
    Miami, United States
  • Research Site
    Verified postcode
    Tampa, United States
  • Research Site
    Verified postcode
    Minneapolis, United States
  • Research Site
    Verified postcode
    Omaha, United States
  • Research Site
    Verified postcode
    New York, United States
  • Research Site
    Verified postcode
    Portland, United States
  • Research Site
    Verified postcode
    Houston, United States
  • Research Site
    Verified postcode
    North Adelaide, Australia
  • Research Site
    Verified postcode
    Essen, Germany
  • Research Site
    Verified postcode
    Rostock, Germany

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of the body and is no longer responding to standard hormone treatments that lower testosterone.

What are AZD2265, AZD9574, and Docetaxel?

These are names of medicines being tested in the study. AZD2265 and AZD9574 are new anti-cancer drugs, while Docetaxel is a type of chemotherapy often used for prostate cancer.

What does a 'Phase Ib/II' study mean?

This refers to the stage of the clinical trial. Phase I studies check if a drug is safe and find the right dose. Phase II studies then look at how well the drug works at that dose.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.

What is PSMA testing?

PSMA testing is a special type of scan that helps doctors see if your cancer has a specific marker on its cells called PSMA, which can help guide treatment.

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?

Register your interest

Share your details and the research team for "Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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