Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

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

Registered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    Entry into the study involves receiving either a standard dose of the medication or a dose that is adjusted based on blood levels of the drug.

  2. Step 2

    Medication administration

    The medication abiraterone acetate is taken by mouth in the form of film-coated tablets.

    The total daily dose of abiraterone acetate is 1500 mg.

  3. Step 3

    Monitoring process

    For individuals in the group receiving therapeutic drug monitoring, blood levels of the medication are measured to determine if the dose needs to be adjusted.

    The goal is to check if the minimum concentration (the lowest amount of the drug found in the blood) is at a specific level.

  4. Step 4

    Evaluation of results

    The effectiveness of the treatment is measured by looking at radiographic progression-free survival, which refers to how long the metastatic castration-resistant prostate cancer stays stable as seen on medical scans.

    Other factors monitored include prostate-specific antigen (PSA) levels, which is a protein used to track the status of the cancer, and overall survival.

Who can join the trial?

6 criteria

  • 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 trial?

8 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Abiraterone acetate - This medication is taken as a film-coated tablet by mouth and is currently used in medicine to treat advanced prostate cancer that no longer responds to hormone therapy. It works by blocking an enzyme that helps the body produce the hormones that fuel cancer growth. Classified as an androgen biosynthesis inhibitor, it stops the production of testosterone in several different parts of the body to help slow down the disease.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524440-35-00Protocol codeM25ABIEstimated enrolment230 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.