AuthorisedTherapeutic confirmatory (Phase III)Interventional

ALADDIN: evaluation of dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases

The ALADDIN study is investigating a new treatment approach for men recently diagnosed with prostate cancer that has spread to lymph nodes in the pelvic area. This Phase III clinical trial will combine darolutamide (BAY 1841788), a new drug, with the usual hormone therapy and radiation treatment. The main goal is to figure out if adding darolutamide helps patients live longer without their cancer returning or getting worse. Researchers will track how long patients remain free from progression, how long they live overall, and how their quality of life is affected. Participants will receive either the new drug or a dummy pill (placebo) along with their standard care. This study could help improve treatment options for this type of prostate cancer.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

ARTIC

Enrolment target

152

Start

05 Nov 2024

Newly diagnosed prostate cancer with pelvic lymph nodes metastases

What is this study about?

The ALADDIN study is a really important research project looking into a new way to treat prostate cancer. When prostate cancer is first found, and it has spread to some of the small glands nearby (called lymph nodes) in your pelvis, doctors want to give the best possible treatment. Currently, standard treatment often involves hormone therapy (drugs like LEUPRORELIN or DEGARELIX, which lower male hormones that feed the cancer) and radiotherapy.

This study is testing if adding a new drug, called darolutamide (also known as BAY 1841788), to this standard treatment can make it even better. Darolutamide works by blocking the male hormone messages that prostate cancer cells use to grow. The hope is that by combining darolutamide with hormone therapy and radiotherapy, we can stop the cancer from growing or spreading for longer. Researchers will carefully follow men in the study to see how long they stay well without their cancer coming back, spreading, or causing new problems.

It’s a 'Phase III' study, which means it’s one of the final steps in testing a new treatment, comparing it against the best current treatment to see if it’s more effective or safer. Findings from studies like ALADDIN can directly lead to new and improved treatments becoming available for patients.

Key takeaways

Tests a new drug (darolutamide) for prostate cancer spread to pelvic lymph nodes.
Combines the new drug with standard hormone therapy and radiotherapy.
Aims to see if the new drug helps control cancer for longer.
Involves regular check-ups and monitoring over several years.
Participants receive either the new drug or a dummy pill.
Could lead to improved treatments for this type of prostate cancer.

Who may be eligible?

This study is specifically for men who have recently been diagnosed with prostate cancer. Your cancer must have spread to the lymph nodes in your pelvis, but not to other parts of your body. You should be at least 18 years old to take part.

Your medical team will check other specific health requirements to make sure the study is a good fit for you and that it would be safe for you to participate. This might include looking at your general health, how your kidneys and liver are working, and whether you have any other serious medical conditions.

It's important to remember that not everyone with prostate cancer that has spread to lymph nodes will be suitable for this specific study. Your doctor will be able to tell you if your individual situation matches the study's requirements.

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.

Have you been recently diagnosed with prostate cancer?
Has your cancer spread to lymph nodes in your pelvis?
Are you at least 18 years old?
Are you male?
Are you able to undertake hormone therapy and radiotherapy?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new drug (darolutamide) or a dummy pill (placebo) alongside your usual hormone treatment and radiotherapy. The study involves regular visits to the hospital or clinic for check-ups. During these visits, doctors will monitor your health, perform blood tests (including checking your PSA levels), and sometimes scans to see how your cancer is responding. They will also ask you questions about how you are feeling and any side effects you might be having, and ask you to complete questionnaires about your quality of life.

The initial treatment period would be followed by a long-term follow-up phase, as researchers need to see how well the treatment works over time. This follow-up is expected to last for at least 5 years. The total time you'd be involved in the study, from starting treatment to the very end of follow-up, could be several years.

Potential risks and benefits

Participating in this study might mean you receive a drug that could improve your treatment outcomes and help keep your cancer under control for longer. However, there's also a chance you might receive a placebo (dummy pill) which wouldn't directly help your cancer, though you would still get standard care. All medications can have side effects, and darolutamide might cause similar side effects to other hormone treatments, or different ones. Your medical team will explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 'failure-free survival'?

It's a way to measure how long you stay well without your cancer getting worse, spreading, or causing new symptoms after starting treatment.

What is 'PSA'?

PSA stands for Prostate-Specific Antigen. It's a protein made by the prostate, and levels in the blood can be used to monitor prostate cancer.

What are 'pelvic lymph nodes metastases'?

This means your prostate cancer has spread to small glands in your pelvis called lymph nodes, but not to other distant parts of your body.

Will I definitely get the new drug?

No, participants will be randomly assigned to receive either the new drug or a placebo (dummy pill) alongside their standard treatment.

What does a 'Phase III' study mean?

It means this is one of the final, large-scale stages of testing a new treatment, comparing it directly to the best existing treatment to see if it's better.