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Study on Enzalutamide and Leuprorelin Acetate for Men with High-Risk Nonmetastatic Prostate Cancer After Treatment

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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 treatments for prostate cancer, specifically in men with high-risk nonmetastatic prostate cancer that is progressing after initial therapy. The study involves three different treatment approaches: a combination of enzalutamide and leuprolide, enzalutamide alone, and leuprolide alone. Enzalutamide is a medication that helps block the effects of male hormones that can promote the growth of cancer cells, while leuprolide is used to lower the levels of these hormones in the body.

The purpose of the study is to evaluate the safety and effectiveness of these treatments. Participants will be randomly assigned to one of the treatment groups and will receive their assigned treatment for a period of up to 90 days. The study will monitor the participants' health and the progression of their prostate cancer during this time. The trial aims to determine which treatment approach is most effective in managing the disease.

Throughout the study, participants will undergo regular check-ups and assessments to track their response to the treatment. The study will also compare the outcomes of the different treatment groups to understand the benefits and potential side effects of each approach. This research is important for improving treatment options for men with high-risk nonmetastatic prostate cancer.

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

    Initial treatment phase

    Upon joining the study, the patient will begin the initial treatment phase. This involves the administration of medications designed to evaluate their effectiveness and safety in treating high-risk nonmetastatic prostate cancer.

    The patient will receive leuprorelin acetate through subcutaneous injection. This medication is used to manage prostate cancer by reducing testosterone levels, which can help slow the growth of cancer cells.

  2. Step 2

    Medication administration

    The patient will be randomly assigned to one of the following treatment groups: enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide.

    If assigned to the enzalutamide group, the patient will take Xtandi (enzalutamide) in the form of 40 mg soft capsules orally. The frequency and duration of this medication will be determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the medication and to identify any side effects.

    The primary goal is to evaluate the efficacy of the combination of enzalutamide plus leuprolide compared to placebo plus leuprolide, as measured by metastasis-free survival (MFS).

  4. Step 4

    Completion of study

    The study is expected to continue until October 31, 2026. Upon completion, the data collected will be analyzed to determine the safety and effectiveness of the treatments.

    The patient will be informed of the study results and any potential implications for their ongoing care.

Who can join the trial?

16 criteria

  • Must be 18 years or older and willing to give permission to participate in the study.
  • Throughout the study, the patient and his female partner who can have children must use 2 acceptable methods of birth control. One method must be a condom. Other options include:
    • Female partner using birth control pills, injections, or implants.
    • Female partner using an intrauterine device (IUD).
    • Female partner using additional barrier methods like a contraceptive sponge or cap with sperm-killing products.
    • Female partner having had a tubal ligation (surgery to prevent pregnancy) at least 6 months before the study.
    • Patient having had a vasectomy or other procedure that causes infertility at least 6 months before the study.
    • Must use a condom if having sex with a pregnant woman during the study.
    • Must agree not to donate sperm from the first dose of the study drug until 3 months after the last dose.
    • Must have a confirmed diagnosis of prostate cancer from a tissue sample, without certain specific cell types.
    • Prostate cancer must have been initially treated with surgery or radiation therapy, or both, with the aim to cure. Previous use of prostate cryoablation (freezing treatment) is allowed but not considered a cure for this study.
    • Must have a PSA (Prostate-Specific Antigen) doubling time of 9 months or less, as calculated by the study sponsor.
    • PSA level must be at least 1 ng/mL for those who had surgery (with or without radiation) and at least 2 ng/mL above the lowest level for those who had only radiation therapy.
    • Serum testosterone level must be at least 150 ng/dL at the start of the study.
    • Must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
    • Must have an estimated life expectancy of at least 12 months.
    • Must be able to swallow the study drug and follow the study requirements.

Who cannot join the trial?

2 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate in the study.
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Investigated drugs

  • Enzalutamide

    is a medication used in this trial to treat men with high-risk nonmetastatic prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, enzalutamide is being tested both on its own and in combination with another medication to see how effective it is in slowing down or stopping the progression of prostate cancer.

  • Leuprolide

    is another medication used in this trial. It is a type of hormone therapy that lowers the levels of testosterone in the body. Testosterone can help prostate cancer cells grow, so by reducing its levels, leuprolide aims to slow down or stop the growth of the cancer. In this study, leuprolide is used in combination with enzalutamide to evaluate the effectiveness of this treatment approach.

What is already known about the treatment

  • Enzalutamide

    Enzalutamide is administered orally in the form of capsules or tablets. It is currently used in the treatment of prostate cancer, particularly in cases where the disease has progressed despite other therapies. The medication works by blocking the action of male hormones, such as testosterone, which can promote the growth of cancer cells. Enzalutamide is classified as an androgen receptor inhibitor, which means it interferes with the signals that tell cancer cells to grow.

  • Leuprolide

    Leuprolide is administered via injection, either under the skin or into a muscle. It is widely used in the treatment of prostate cancer by reducing the levels of testosterone in the body, which helps slow the growth of cancer cells. The drug acts as a gonadotropin-releasing hormone (GnRH) agonist, initially increasing hormone levels before significantly decreasing them, leading to reduced stimulation of cancer cell growth. Leuprolide is classified as a hormone therapy medication.

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. As the cancer progresses, it may spread to nearby tissues or other parts of the body. Early stages often have no symptoms, but as it advances, it can cause urinary problems, pelvic discomfort, or bone pain. The growth rate of prostate cancer can vary, with some types growing slowly and others more aggressively. Monitoring and understanding the progression is crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513521-23-00Protocol codeC3431004/MDV3100-13Estimated enrolment1 068 patientsSponsorMedivation Inc.

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