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Study Comparing MK-5684 with Abiraterone Acetate or Enzalutamide for Patients with Advanced Prostate Cancer After Hormonal Therapy and Chemotherapy

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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 condition known as metastatic castration-resistant prostate cancer (mCRPC). This is a type 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 comparing a new treatment called MK-5684 with two existing medications, abiraterone acetate and enzalutamide, which are already used to treat this type of cancer. The purpose of the study is to see how well MK-5684 works compared to the other two medications in terms of helping patients live longer and slowing down the progression of the cancer.

Participants in the study will receive either MK-5684 or one of the approved medications, abiraterone acetate or enzalutamide. The study will monitor the participants over a period to assess their overall survival and the progression of their cancer. The study will also look at other factors such as the time it takes for the cancer to progress, the response to the treatment, and any side effects experienced by the participants. The study aims to provide valuable information on the effectiveness and safety of MK-5684 as a potential treatment option for patients with mCRPC.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather data on the treatment's impact. The study will help determine if MK-5684 can offer a new and effective treatment option for those with advanced prostate cancer who have already undergone hormonal therapy and chemotherapy. This research is important for advancing the understanding and treatment of metastatic castration-resistant 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

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the new treatment MK-5684 or an alternative approved medication, which could be abiraterone acetate or enzalutamide.

    The assignment is open-label, meaning both the participant and the study team will know which treatment is being administered.

  2. Step 2

    Treatment administration

    Participants receiving MK-5684 will take the medication orally as directed by the study protocol.

    Participants assigned to abiraterone acetate will take the medication orally, typically once daily, as per standard dosing guidelines.

    Participants assigned to enzalutamide will also take the medication orally, usually once daily, following standard dosing instructions.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will occur to assess the participant's health and response to the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

    Participants will be assessed for overall survival and progression-free survival, which measures the time during and after treatment that the participant lives with the disease without it getting worse.

  4. Step 4

    Follow-up

    After completing the treatment phase, participants will enter a follow-up period where their health and any long-term effects of the treatment will be monitored.

    The follow-up period will include regular check-ups and assessments to ensure the participant's well-being and to gather data on the long-term efficacy and safety of the treatment.

Who can join the trial?

14 criteria

  • The patient must have a confirmed type of prostate cancer called **adenocarcinoma**, which is not a small cell type.
  • The patient must provide a sample of tumor tissue from a recent biopsy that was not previously treated with radiation.
  • If the patient is infected with **HIV**, their condition must be well controlled with medication.
  • The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • If the patient has **hepatitis B**, they must have been treated for at least 4 weeks and have no detectable virus in their blood.
  • If the patient had **hepatitis C**, the virus must not be detectable in their blood at the time of screening.
  • The patient's prostate cancer must have worsened while on hormone therapy or after surgical removal of the testicles within 6 months before screening.
  • If the patient used certain anti-androgen medications, their disease must have worsened more than 4 weeks after stopping flutamide and more than 6 weeks after stopping bicalutamide or nilutamide.
  • The patient must have evidence of cancer that has spread to other parts of the body, shown by bone or soft tissue scans.
  • The patient's disease must have worsened during or after treatment with one new type of hormone therapy.
  • The patient must have received one or two chemotherapy treatments based on taxane for their cancer and have had disease progression during or after these treatments.
  • The patient must continue hormone therapy to keep testosterone levels below 50 ng/dL.
  • If the patient is receiving treatment to prevent bone loss, they must have been on a stable dose for at least 4 weeks before starting the study.
  • If the patient can produce sperm, they must agree not to donate sperm and either abstain from sex or use a condom during the study and for a specified time after the last dose of study medication.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than metastatic castration-resistant prostate cancer cannot participate. This type of cancer is a form of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are female cannot participate, as the study is only for male patients.
  • Patients who are considered part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study is for adults, typically those who are older.
  • Patients who have not been diagnosed with the specific condition being studied, which is metastatic castration-resistant prostate cancer, are not eligible.
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Investigated drugs

  • MK-5684

    is an investigational medication being studied for its potential to improve survival in patients with metastatic castration-resistant prostate cancer (mCRPC). It is being compared to other treatments to see if it can help patients live longer and slow down the progression of the disease.

  • Abiraterone Acetate

    is a medication used to treat prostate cancer by lowering the levels of male hormones in the body, which can help slow the growth of cancer cells. In this study, it is used as a comparison treatment to evaluate the effectiveness of MK-5684.

  • Enzalutamide

    is another treatment option for prostate cancer that works by blocking the effects of male hormones on cancer cells, helping to slow their growth. It is also used in this trial as a comparison to assess the benefits of MK-5684.

What is already known about the treatment

  • MK-5684

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness 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 who have previously been treated with next-generation hormonal agents and taxane-based chemotherapy. MK-5684 works by targeting specific pathways involved in cancer cell growth and survival, although the exact molecular mechanism is still being researched. It is classified under investigational cancer therapies.

  • Abiraterone Acetate

    This medication is taken orally and is well-established in medical practice for treating metastatic castration-resistant prostate cancer. It is widely documented in medical literature and is used primarily for patients who have not responded to other hormonal treatments. Abiraterone Acetate works by inhibiting an enzyme called CYP17, which is involved in the production of androgens, hormones that can promote the growth of prostate cancer cells. It is classified as an androgen biosynthesis inhibitor.

  • Enzalutamide

    This medication is administered orally and is a recognized treatment for metastatic castration-resistant prostate cancer. It is well-documented in medical literature and is used for patients who have not responded to other hormonal therapies. Enzalutamide works by blocking the action of androgens at their receptor sites, preventing them from stimulating cancer cell growth. It 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 cancer cells that have spread beyond the prostate gland to other parts of the body, such as bones or lymph nodes. The disease progresses despite hormonal therapy aimed at lowering testosterone, which is typically used to control prostate cancer growth. Over time, the cancer cells adapt and continue to thrive without the need for high levels of androgens, which are male hormones. This condition is often associated with mutations in the androgen receptor, which can affect the cancer's response to treatment. The progression of the disease can lead to various symptoms, including pain and complications related to the spread of cancer to other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504899-25-00Protocol codeMK-5684-003Estimated enrolment1 244 patientsSponsorMerck Sharp & Dohme LLC

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