Comparison of standard dosing and blood level monitoring of abiraterone acetate for patients with metastatic castration-resistant prostate cancer

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What is this study about?

This study focuses on metastatic castration-resistant prostate cancer, a type of prostate cancer that continues to grow even when testosterone levels are lowered through medical treatment. The research investigates the use of abiraterone acetate, which is an oral medication used to treat this condition. The goal of the study is to compare the effectiveness of a standard fixed dose of the medication against a method where the dose is adjusted based on therapeutic drug monitoring, which involves measuring the amount of medicine in the blood to guide the correct dosage.

Participants in the study will receive either the standard amount of abiraterone acetate or a dose that is customized based on regular blood tests. These blood tests help determine the Cmin, which refers to the lowest concentration of the drug found in the blood between doses. By monitoring these levels, doctors can see if adjusting the amount of medicine improves the time during which the cancer does not appear to grow on imaging tests, a measurement known as radiographic progression-free survival. Throughout the study, various factors such as prostate-specific antigen (a protein often used to track prostate cancer activity) and overall health will be observed.

Who Can Join the Study?

You must be a male aged 18 years or older.
You must have metastatic castration-resistant prostate cancer, which is a type of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy used to lower testosterone levels.
Your prostate cancer must be confirmed through histology or cytology, which means a doctor has examined your cells under a microscope to prove the cancer is present.
You must either have never received chemotherapy (drugs used to kill cancer cells) for this condition, or you must have completed exactly one course of a specific type of chemotherapy called docetaxel.
You must have measurable disease, meaning the tumors in your body are large enough and clear enough to be accurately tracked and measured using standard medical imaging rules called RECIST criteria.
You must provide a signed informed consent form, which is a written document you sign to show you understand the study and agree to participate before any medical tests begin.

Who Cannot Join the Study?

You have metastatic hormone sensitive prostate cancer, which is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy.
You have previously taken androgen receptor signaling inhibitors, which are specific medications used to treat prostate cancer by blocking the hormones that help cancer cells grow.
You have any other important medical conditions that the doctor believes could be made worse by the study drug.
You have used certain medicines that affect the CYP3A4 enzyme, which is a protein in the body that helps break down and clear drugs, within the last 14 days or during the study.
You have taken medications that cause severe QT prolonging effects, which refers to changes in the electrical activity of the heart that can affect its rhythm.
You have any medical condition that could interfere with the study or how your body absorbs oral medications, which is the process of a medicine moving from the digestive system into the bloodstream.
You have any condition that the doctor believes would make it too risky for you to participate in this study.
You have any psychological, family, social, or living situation issues that might make it difficult for you to follow the study rules or attend all follow-up appointments.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.05.2026

Trial locations

Investigated drugs:

Abiraterone Acetate

Abiraterone is a medication taken by mouth that is used to treat prostate cancer by lowering the amount of hormones that help the cancer grow.

Investigated diseases:

Hormone-refractory prostate cancer

Metastatic castration-resistant prostate cancer – This is a type of prostate cancer that continues to grow even after medical treatments have lowered testosterone levels in the body. The cancer cells in the prostate gland eventually become less sensitive to hormone therapies designed to reduce testosterone. As the disease advances, the cancer cells can spread from the original site in the prostate to other parts of the body, such as the bones or other organs. This progression is often marked by an increase in certain proteins in the blood used to track the disease.

Trial ID:

2025-524440-35-00

Protocol code:

M25ABI

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of standard dosing and blood level monitoring of abiraterone acetate for patients with metastatic castration-resistant prostate cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?