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

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 condition known as metastatic castration-resistant prostate cancer, which is a type of advanced prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. The trial is comparing a new treatment called MK-5684 to existing medications, specifically abiraterone acetate and enzalutamide. These medications are used to treat prostate cancer that has spread to other parts of the body and has not responded to previous hormonal treatments.

The purpose of the study is to evaluate how well MK-5684 works compared to the other medications in terms of delaying the progression of the cancer and improving overall survival. Participants in the study will be randomly assigned to receive either MK-5684 or one of the alternative treatments. The study will involve regular check-ups and assessments to monitor the cancer's response to the treatment. These assessments may include imaging tests like MRI or CT scans to track changes in the cancer.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The trial aims to provide valuable information on the effectiveness and safety of MK-5684 as a potential new treatment option for patients with advanced prostate cancer. The study will continue for a set period, during which participants will receive the assigned treatment and undergo regular evaluations to assess their health and the progression of their cancer.

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

    Enrollment

    Upon joining the study, confirmation of prostate cancer diagnosis is required. This includes a review of medical history and current health status.

    Eligibility is determined based on specific criteria, such as previous treatments and current health conditions.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the new treatment MK-5684 or an alternative approved medication, such as abiraterone acetate or enzalutamide.

    This process ensures that each participant has an equal chance of receiving any of the treatments.

  3. Step 3

    Treatment administration

    The treatment involves taking oral medications. The specific medication and dosage depend on the group assignment.

    Participants will take the medication as prescribed, with regular monitoring to assess the response to treatment.

  4. Step 4

    Monitoring and assessments

    Regular check-ups are scheduled to monitor health status and treatment effects. This includes blood tests, imaging scans, and other necessary evaluations.

    Participants are assessed for any side effects or adverse reactions to the treatment.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits are conducted to evaluate long-term effects and overall health.

    The follow-up period helps in understanding the duration of response and any delayed side effects.

Who can join the trial?

13 criteria

  • Must have a confirmed diagnosis of prostate cancer, specifically a type called adenocarcinoma, without any small cell features.
  • Must have prostate cancer that has progressed while receiving a treatment called androgen deprivation therapy (ADT) or after surgical removal of the testicles within 6 months before the study starts.
  • Must have evidence of cancer that has spread to other parts of the body, shown by bone scans or imaging tests like CT or MRI.
  • Must have cancer that got worse during or after treatment with a specific type of hormonal therapy for prostate cancer, for at least 8 weeks (or 14 weeks if the cancer spread to bones). Participants may have received certain drugs like abiraterone acetate and docetaxel or darolutamide and docetaxel, but no more than six cycles of docetaxel and no worsening of cancer on scans while on docetaxel.
  • Must have had previous treatment with a type of drug called Poly polymerase inhibitors (PARPi) or have been considered unsuitable for this treatment by the doctor or have refused it.
  • Must be continuing with androgen deprivation therapy, with a testosterone level below 50 ng/dL.
  • Must have a performance status of 0 or 1 on a scale used to assess how well a person can perform daily activities, evaluated within 7 days before joining the study.
  • Must have adequate organ function, meaning the organs are working well enough.
  • Must provide a sample of tumor tissue from a recent biopsy of soft tissue that hasn't been treated with radiation before. Samples from tumors that have grown back in a previously treated area are allowed.
  • If positive for hepatitis B, must have received antiviral therapy for at least 4 weeks and have no detectable virus before joining the study.
  • If previously infected with hepatitis C, must have no detectable virus at the time of screening.
  • If there were side effects from previous cancer treatments, they must have improved to a mild level or returned to the level before treatment. If there are hormone-related side effects, they must be well-managed with hormone replacement therapy, or if there is mild nerve damage, it is acceptable.
  • If infected with HIV, must have the infection well-controlled with antiretroviral therapy.

Who cannot join the trial?

3 criteria

  • Participants who do not have metastatic castration-resistant prostate cancer. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Participants who are female, as the study is only for male subjects.
  • Participants who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • MK-5684

    is an investigational medication being studied for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). This medication is being compared to other treatments to see if it can help slow down the progression of the cancer and improve overall survival in patients who have already been treated with another hormonal therapy.

  • Abiraterone Acetate

    is a medication used to treat prostate cancer by reducing the production of male hormones that can promote 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. It is used in this trial to compare its effectiveness against MK-5684 in patients with metastatic castration-resistant prostate cancer.

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 for MK-5684 is to manage prostate cancer that has progressed despite previous hormonal treatments. At the molecular level, MK-5684 works by targeting specific pathways involved in cancer cell growth and survival, although the exact mechanism is still being researched. It is classified pharmacologically as an investigational anti-cancer agent.

  • 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 to reduce the production of androgens, which can fuel prostate cancer growth. Abiraterone Acetate works by inhibiting an enzyme called CYP17, which is crucial for androgen production. It is classified as an androgen biosynthesis inhibitor.

  • Enzalutamide

    Administered orally, Enzalutamide is a well-known medication used in the treatment of metastatic castration-resistant prostate cancer. It is extensively covered in medical literature and is indicated for patients whose cancer has progressed after other hormonal therapies. Enzalutamide functions by blocking the action of androgens at the receptor level, 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 to other parts of the body despite treatments that lower testosterone levels. It is characterized by the cancer's ability to resist hormonal therapy, which is typically used to slow its progression. The disease often spreads to bones, lymph nodes, and other organs, leading to various symptoms depending on the areas affected. Patients may experience pain, fatigue, and other symptoms related to the spread of cancer. The progression of this disease can vary, with some patients experiencing rapid advancement while others may have a slower progression. The focus of research and treatment is often on managing symptoms and slowing the spread of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504957-11-00Protocol codeMK-5684-004Estimated enrolment1 289 patientsSponsorMerck Sharp & Dohme LLC

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