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Study Comparing Radium-223 Dichloride with Abiraterone Acetate, Enzalutamide, and Prednisone in Patients with Advanced Prostate Cancer Spread to the Bone

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What is this trial about?

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

This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that has spread to other parts of the body, particularly the bones, and continues to grow even when the amount of testosterone in the body is reduced to very low levels. The study is comparing two treatments: Radium-223 dichloride (Xofigo), which is a treatment that emits radiation to help kill cancer cells, and a new type of treatment that inactivates hormones, known as novel anti-hormonal therapy (NAH). The purpose of the study is to assess the overall survival of patients receiving Radium-223 dichloride compared to those receiving a second line of NAH.

Participants in the study will receive either Radium-223 dichloride or one of the NAH treatments, which may include medications such as abiraterone acetate (Zytiga), enzalutamide (Xtandi), prednisone, or prednisolone. These medications are taken orally, except for Radium-223 dichloride, which is given as an injection. The study will monitor the participants over a period to observe the effects of the treatments on their cancer and overall health. The study will also look at other factors such as the time it takes for symptoms to worsen, any side effects experienced, and the impact on the participants' quality of life.

This trial aims to provide valuable information on the effectiveness and safety of Radium-223 dichloride compared to NAH in treating patients with mCRPC. By participating in this study, researchers hope to better understand which treatment option may offer the best outcomes for patients with this type of prostate cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment being studied.

  2. Step 2

    Treatment with radium-223 dichloride

    Participants in this group receive radium-223 dichloride, which is administered as an intravenous injection. This treatment is given once every four weeks for a total of six injections.

    Radium-223 dichloride is a radioactive substance that targets cancer cells in the bones.

  3. Step 3

    Treatment with novel anti-hormonal therapy (NAH)

    Participants in this group receive a standard dose of a novel anti-hormonal therapy. This may include medications such as abiraterone acetate or enzalutamide, which are taken orally.

    Abiraterone acetate is taken as 500 mg film-coated tablets, while enzalutamide is taken as 40 mg soft capsules. The specific dosage and frequency depend on the medication prescribed by the study team.

  4. Step 4

    Concomitant medication

    Participants may also receive prednisone or prednisolone as part of their treatment regimen. These are oral medications taken as 5 mg tablets to help manage side effects and support the main treatment.

  5. Step 5

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring and assessments to evaluate their health and the effectiveness of the treatment. This includes blood tests, imaging studies, and questionnaires about symptoms and quality of life.

    The primary goal is to assess overall survival, while secondary goals include monitoring for skeletal events, progression of the disease, and any side effects experienced.

  6. Step 6

    End of treatment

    The treatment phase concludes after the completion of the prescribed regimen. Participants continue to be monitored for any long-term effects and overall health outcomes.

Who can join the trial?

15 criteria

  • Participant must be at least 18 years old at the time of signing the informed consent.
  • Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, which means the participant is fully active or has some symptoms but can still carry out light work.
  • Must have a life expectancy of at least 6 months.
  • Must be able to swallow certain medications as whole tablets or capsules.
  • Must meet specific laboratory test requirements, such as having a certain level of blood cells, liver function, and kidney function.
  • Must be male and agree to use contraception if they have a partner who can become pregnant.
  • Must be able to give signed informed consent, agreeing to follow the study's requirements.
  • Must have a confirmed diagnosis of prostate cancer.
  • Must have prostate cancer that has progressed after treatment with certain approved medications for at least 3 months.
  • Must have had at least two cycles of a specific type of chemotherapy for prostate cancer or be unable or unwilling to have such treatment.
  • Must have evidence of prostate cancer progression based on specific criteria.
  • Must have at least two bone metastases, which are cancer spots in the bones, and no history of cancer spread to the lungs, liver, or brain.
  • Must have symptoms of prostate cancer, such as pain, assessed during the screening period.
  • Must maintain low testosterone levels through medical or surgical means.
  • Must be on treatment to protect bones unless it is not recommended by the doctor.

Who cannot join the trial?

4 criteria

  • Patients who do not have metastatic castrate resistant prostate cancer (mCRPC). This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are not male. This study is only for male participants.
  • Patients who are not within the specified age range. The study is for certain age groups, so if you are outside this range, you cannot participate.
  • Patients who belong to a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.
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Investigated drugs

  • Radium-223 Dichloride

    is a type of radiation therapy used to treat prostate cancer that has spread to the bones. It works by delivering targeted radiation to the cancer cells in the bones, helping to slow down the growth of the cancer and reduce symptoms such as pain.

  • Novel Anti-Hormonal Therapy (NAH)

    refers to a group of medications that block the effects of male hormones, which can help slow the growth of prostate cancer. These therapies are used when the cancer continues to grow despite other treatments that lower hormone levels.

What is already known about the treatment

Radium-223 Dichloride – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating bone-dominant metastatic castration-resistant prostate cancer (mCRPC). It is approved for use in certain cancer treatments and is well-documented in medical literature. The main therapeutic indication is for patients with mCRPC, particularly those whose cancer has spread to the bones. Radium-223 works by mimicking calcium and targeting bone metastases, where it emits radiation to kill cancer cells. It is classified as a radiopharmaceutical, specifically a targeted alpha therapy.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have become resistant to hormonal therapy, which is typically used to control prostate cancer growth. The disease often spreads to bones and can lead to symptoms such as bone pain and fractures. As the cancer progresses, it may cause urinary problems, fatigue, and weight loss. The progression of the disease is monitored through various clinical endpoints, including overall survival and time to symptomatic skeletal events.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505830-89-00Protocol code20510Estimated enrolment806 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).