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Study on Long-Term Safety of Enzalutamide, Abiraterone, and Prednisolone for Patients with Prostate Cancer from Previous Enzalutamide Trials

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What is this trial about?

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

This clinical trial focuses on studying the long-term safety of a treatment for Prostate Cancer. The treatment being studied is a medication called Enzalutamide, which is taken as a soft capsule. This study is specifically for individuals who have previously participated in an enzalutamide clinical study and are continuing to benefit from the treatment. The purpose of the study is to gather information on the safety of enzalutamide over an extended period.

Participants in this study will continue to take enzalutamide as they did in their previous study. The study will monitor their health and any side effects they may experience while taking the medication. The study will last for a maximum of 36 months, during which participants will take enzalutamide daily. The study will also involve the use of other medications, such as Abiraterone and Prednisolone, which are also taken orally. These medications are used in combination with enzalutamide to manage prostate cancer.

Throughout the study, participants will be regularly assessed by healthcare professionals to ensure their safety and to determine the ongoing benefits of the treatment. The study aims to provide valuable information on the long-term use of enzalutamide and its effects on individuals with prostate cancer. Participants will be required to follow specific guidelines, such as using birth control methods, to ensure their safety and the integrity of the study results.

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

    Joining the study

    Participation begins after providing written consent and agreeing to privacy terms as per national regulations.

    Eligibility requires current treatment with enzalutamide for prostate cancer in a previous study sponsored by Astellas or Medivation/Pfizer, with continued benefit from the treatment as assessed by the investigator.

  2. Step 2

    Treatment continuation

    Continue the treatment regimen from the prior study. Any changes to the treatment plan, such as dose adjustments or stopping a combination therapy, require approval from a medical monitor.

    The ability to swallow enzalutamide capsules and comply with study requirements is necessary.

  3. Step 3

    Medication details

    The study involves the oral administration of enzalutamide, abiraterone, and prednisolone.

    The specific dosage and frequency of these medications will be determined by the investigator based on the previous study regimen.

  4. Step 4

    Safety and compliance

    The main objective is to collect long-term safety data for those continuing to benefit from enzalutamide treatment.

    Participants and their female partners of childbearing potential must use two forms of birth control during the study and for three months after the final administration of enzalutamide. One method must be highly effective, and the other must be a barrier method.

  5. Step 5

    Study duration

    The estimated end date for the study is January 17, 2025.

    Participants are required to avoid sperm donation during the study and for at least three months after the final administration of enzalutamide.

Who can join the trial?

6 criteria

  • The patient must provide a written agreement to participate in the study, which includes understanding privacy rules. This is called an Informed Consent.
  • The patient must currently be receiving a medication called enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation/Pfizer and must be benefiting from the treatment according to the doctor's assessment.
  • The patient must be able to continue the treatment they were receiving in the previous study. If the doctor thinks a change is needed, such as adjusting the dose or stopping a combination therapy, approval from a medical monitor is required before joining the study.
  • The patient must be able to swallow enzalutamide capsules and follow the study requirements.
  • The patient and his female partner, if she can have children, must use two forms of birth control during the study and for three months after the last dose of enzalutamide. One form must be highly effective, like hormonal methods or an intrauterine device, and the other must be a barrier method, like a condom.
  • The patient must agree not to donate sperm during the study and for at least three months after the last dose of enzalutamide.

Who cannot join the trial?

5 criteria

  • Only male patients can participate in the study. Female patients are not eligible.
  • Patients who have not participated in a previous clinical study with the medication Enzalutamide are not eligible. Enzalutamide is a drug used in the treatment of prostate cancer.
  • Patients who did not benefit from the treatment in the previous study with Enzalutamide cannot participate. This means the treatment did not help them as expected.
  • Patients who were part of a study that has not yet completed its main analysis or evaluation period are not eligible. This means the previous study must have finished its main part.
  • Patients who are considered part of a vulnerable population are not eligible. A vulnerable population includes people who might need special protection or care.
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Investigated drugs

Enzalutamide is a medication used in this clinical trial for patients with prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. This study aims to gather long-term safety data for patients who have previously benefited from this treatment in earlier studies.

What is already known about the treatment

Enzalutamide – Enzalutamide is administered orally in the form of capsules. It is currently used in the treatment of prostate cancer and is well-documented in medical literature as an effective therapy for this condition. The main therapeutic indication for enzalutamide is prostate cancer, particularly in patients who have previously participated in clinical studies. At the molecular level, enzalutamide works by inhibiting the action of androgens, which are male hormones that can promote the growth of cancer cells. It belongs to the pharmacological class of androgen receptor inhibitors.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This type of cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. In some cases, prostate cancer can spread to other parts of the body, such as the bones or lymph nodes. The progression and symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510298-33-00Protocol code9785-CL-0123Estimated enrolment831 patientsSponsorAstellas Pharma Global Development Inc.

sourced from the EU Clinical Trials Register and site verification

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