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Study of enzalutamide alone versus enzalutamide with radium-223 combination in patients with bone metastatic castration-resistant prostate cancer with mild or no symptoms

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with castration-resistant prostate cancer that has spread to the bones (bone metastases). The research compares two treatment approaches: using enzalutamide alone versus combining enzalutamide with radium-223 dichloride. Enzalutamide is a medication that blocks the effects of male hormones in the body, while radium-223 dichloride is a radioactive substance that targets cancer cells in the bones.

The purpose of this study is to determine if using both medications together works better than using enzalutamide by itself in patients who have either no symptoms or mild symptoms from their cancer. The study will evaluate how well these treatments prevent the cancer from getting worse based on imaging scans.

During the study, patients will receive either enzalutamide capsules taken by mouth daily, or enzalutamide capsules plus radium-223 dichloride given through an intravenous injection. The treatment period may last up to 120 weeks for enzalutamide and 24 weeks for radium-223 dichloride. Patients will also receive medications to protect their bones during the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Enzalutamide (Xtandi) alone - soft capsules taken by mouth

    Group 2: Enzalutamide plus Radium-223 (Xofigo) - capsules taken by mouth plus intravenous injections

  2. Step 2

    Bone protection medication

    If you are assigned to the combination treatment group, you will need to receive bone-protecting medication

    At least two doses of bone protection medication must be given before starting Radium-223

    The first Radium-223 treatment will be scheduled at least 6 weeks after starting bone protection medication

  3. Step 3

    Regular monitoring

    Your blood will be tested regularly to check:

    - Blood cell counts

    - Liver function

    - Kidney function

    Pain levels will be assessed using a standardized questionnaire

    Quality of life will be evaluated using specific assessment forms

  4. Step 4

    Imaging scans

    Regular scans will be performed to monitor your bone metastases

    Additional scans may be needed to confirm any unclear findings

  5. Step 5

    Treatment duration

    Treatment will continue until one of the following occurs:

    - Your disease shows progression on scans

    - You develop significant side effects

    - Your pain significantly increases

    The study is planned to continue until December 2027

Who can join the trial?

16 criteria

  • Must have confirmed prostate adenocarcinoma (a type of prostate cancer) through tissue examination
  • Must have testosterone levels below 50 ng/dL due to medical treatment
  • Must have adequate blood test results including: - Normal white blood cell count - Normal platelet count - Hemoglobin level of at least 10.0 g/dl - Normal liver function tests - Normal kidney function - Adequate protein (albumin) levels
  • Must have normal heart function shown by ECG test
  • Must be able to swallow medications and follow study requirements
  • Must have at least 4 bone metastases (areas where cancer has spread to the bone)
  • Must show disease progression according to specific medical criteria
  • Must be currently receiving hormone therapy for prostate cancer
  • Must be at least 18 years old
  • Must have good physical function (WHO Performance status 0-1)
  • Must have a Charlson score (measure of other health conditions) of 3 or less
  • Must have adequate bone density as shown by DXA scan
  • Must have mild or no pain symptoms
  • Must use appropriate birth control if sexually active with partners who could become pregnant
  • Must provide written informed consent to participate in the study
  • Must be able to comply with all study requirements and follow-up visits

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Female patients (study is only for male participants)
  • Patients who do not have confirmed castration resistant prostate cancer (a type of prostate cancer that continues to grow even when testosterone levels are reduced)
  • Patients without bone metastases (cancer that has spread to the bones)
  • Patients currently receiving other experimental treatments or participating in other clinical trials
  • Patients with severe heart, liver, or kidney problems
  • Patients with active infections or other serious medical conditions
  • Previous treatment with enzalutamide (a medication used to treat prostate cancer)
  • Previous treatment with radium-223 (Ra223, a radioactive medication used to treat bone metastases)
  • Known allergies or hypersensitivity to the study medications
  • Inability to follow study procedures or attend scheduled visits
  • Patients with conditions that could interfere with the evaluation of study results
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Investigated drugs

  • Enzalutamide

    A medication used to treat prostate cancer. It works by blocking the effects of testosterone and other male hormones that can stimulate cancer growth. This medication is taken orally and is specifically used in patients with castration-resistant prostate cancer.

  • Radium-223 (Ra223)

    A radioactive medication that is injected into the bloodstream to treat prostate cancer that has spread to the bones. It works by delivering radiation directly to bone tumors, helping to destroy cancer cells while limiting damage to surrounding healthy tissue. This treatment is particularly effective for patients whose prostate cancer has spread to their bones.

What is already known about the treatment

  • Enzalutamide

    An oral medication used in the treatment of metastatic castration-resistant prostate cancer, particularly in patients with bone metastases. This hormone therapy drug works by blocking the effects of androgens (male hormones) by binding to androgen receptors and preventing them from stimulating cancer cell growth. It belongs to the class of androgen receptor inhibitors and is taken in tablet form daily, representing a significant advancement in the treatment of advanced prostate cancer with proven effectiveness in improving survival rates and quality of life.

  • Radium-223 (Ra223)

    A targeted radiopharmaceutical medication administered intravenously for the treatment of castration-resistant prostate cancer that has spread to the bones. This alpha-emitting radioactive substance specifically targets areas of bone metastases, delivering radiation that damages cancer cell DNA while minimizing effects on surrounding healthy tissue. It belongs to the therapeutic radiopharmaceuticals class and is typically given in a series of injections at four-week intervals, showing effectiveness in extending survival and reducing bone-related complications in prostate cancer patients.

Investigated diseases

Castration-Resistant Prostate Cancer - A form of advanced prostate cancer that continues to progress despite medical or surgical treatments that lower testosterone. In this condition, cancer cells adapt to grow and spread even with very low levels of testosterone in the body. The disease typically develops from regular prostate cancer after initial hormone therapy stops working. When the cancer spreads (metastasizes) to bones, it can form new tumors in the bone tissue. The cancer cells in this stage can continue to grow and multiply even when standard hormone-blocking treatments are being used. This form of cancer commonly spreads to specific parts of the body, with bone being one of the most frequent sites of metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510453-41-00Estimated enrolment446 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

sourced from the EU Clinical Trials Register and site verification

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