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Study of EPI-7386 and Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer

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 clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer. This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is testing a new treatment approach that combines two medications: EPI-7386 and enzalutamide. EPI-7386 is a new drug being developed, while enzalutamide is an existing medication used to treat prostate cancer. The purpose of the study is to see if the combination of these two drugs is more effective than using enzalutamide alone.

Participants in the study will receive either the combination of EPI-7386 and enzalutamide or enzalutamide by itself. The study will be conducted in two phases. In the first phase, the focus will be on determining the safety and appropriate dosage of the combination treatment. In the second phase, the study will evaluate how well the combination works in treating the cancer compared to enzalutamide alone. Throughout the study, participants will be monitored for any side effects and changes in their health.

The study aims to provide valuable information on whether the combination of EPI-7386 and enzalutamide can offer a better treatment option for patients with metastatic castration-resistant prostate cancer. By comparing the effects of the combination treatment to enzalutamide alone, researchers hope to find a more effective way to manage this challenging form of 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

    Joining the study

    Upon joining the study, the patient will begin participation in a clinical trial focused on metastatic castration-resistant prostate cancer.

    The trial involves the use of two medications: EPI-7386 and enzalutamide.

  2. Step 2

    Medication administration

    The patient will receive EPI-7386 in the form of a film-coated tablet and enzalutamide as a 40 mg soft capsule.

    Both medications are taken orally.

  3. Step 3

    Phase 1 objectives

    The initial phase aims to determine the safety and tolerability of EPI-7386 when combined with a fixed dose of enzalutamide.

    This phase will also establish the recommended dose for the next phase.

  4. Step 4

    Phase 2 objectives

    The second phase evaluates the effectiveness of the combination of EPI-7386 and enzalutamide compared to enzalutamide alone.

    Safety assessments continue during this phase.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, the patient will undergo regular monitoring, including laboratory tests and imaging scans, to assess the response to treatment.

    The patient's health and any side effects will be closely observed.

  6. Step 6

    Completion of the trial

    The trial is expected to conclude by September 30, 2026.

    Upon completion, the patient's participation in the study will end, and final assessments will be conducted.

Who can join the trial?

18 criteria

  • Must provide written consent approved by an ethics committee before any study procedures.
  • Serum testosterone levels must be 1.73 nmol/L (50 ng/dL) or lower.
  • If taking medications for bone health, like bisphosphonates or denosumab, the dose must be stable for at least 28 days before starting the study treatment.
  • Must have adequate organ function, which includes:
    • Enough white blood cells and platelets, and a certain level of hemoglobin.
    • Normal liver function tests, except for those with Gilbert's Syndrome.
    • Normal kidney function.
    • Normal levels of a protein called albumin.
    • If capable of having children, must agree to use effective birth control methods and avoid donating sperm during the study and for 3 months after the last treatment dose.
    • Any side effects from previous treatments must have improved to a mild level.
    • Must be willing and able to follow the study protocol, including attending follow-up visits and exams.
    • Must be a male aged 18 years or older.
    • Must have confirmed prostate cancer without certain features like small cell or neuroendocrine characteristics.
    • Must have evidence of castration-resistant prostate cancer, which means the cancer continues to grow despite low testosterone levels.
    • Must have metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by scans.
    • Must not have used second-generation anti-androgens before. Previous use of a drug called docetaxel in a specific setting is allowed.
    • Must show evidence of progressive disease, meaning the cancer is getting worse, based on specific criteria like rising PSA levels or new lesions on scans.
    • Must have an ECOG performance status of 0 or 1, indicating the ability to carry out daily activities with little or no assistance.
    • Must be undergoing ongoing androgen deprivation therapy or have had surgery to remove the testicles, with testosterone levels at a castrate level.

Who cannot join the trial?

3 criteria

  • Patients who have already received treatment with second-generation anti-androgens cannot participate. These are medications used to treat prostate cancer by blocking male hormones.
  • Only male patients are eligible for this study, so female patients cannot participate.
  • Patients who are part of a vulnerable population, which means they might have special needs or circumstances that require extra protection, are not eligible.
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Investigated drugs

  • EPI-7386

    is an experimental medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested in combination with another medication to see if it can improve treatment outcomes for patients who have not previously received second-generation anti-androgens.

  • Enzalutamide

    is a medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, enzalutamide is used both alone and in combination with EPI-7386 to evaluate its effectiveness and safety in treating metastatic castration-resistant prostate cancer.

What is already known about the treatment

  • EPI-7386

    EPI-7386 is administered orally and is currently being studied in clinical trials for its potential use in treating metastatic castration-resistant prostate cancer. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is for patients with this specific type of prostate cancer. EPI-7386 works by inhibiting the androgen receptor, which plays a crucial role in the growth of prostate cancer cells. It is classified as an anti-androgen medication.

  • Enzalutamide

    Enzalutamide is an oral medication that is already approved and widely used in the treatment of metastatic castration-resistant prostate cancer. It is well-documented in medical literature and is a standard treatment option for this condition. The drug works by blocking the effects of androgens, which are hormones that can promote the growth of prostate cancer cells. Enzalutamide is classified as an androgen receptor inhibitor.

Investigated diseases

Metastatic castration-resistant prostate cancer – This is a type of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. It is characterized by the cancer's ability to metastasize, or spread, to other parts of the body such as bones and lymph nodes. The disease progresses despite treatments that lower testosterone, which is a hormone that typically fuels prostate cancer growth. Over time, the cancer cells adapt and find ways to thrive even in the absence of testosterone. This condition is often associated with symptoms like bone pain and urinary issues due to the spread of cancer. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509336-25-00Protocol codeEPI-7386-CS-010Estimated enrolment138 patientsSponsorEssa Pharma Inc.

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