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Study of PF-06821497 with Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate

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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 testosterone in the body is reduced to very low levels. The study will explore the effects of an investigational medicine called PF-06821497 (also known as mevrometostat) when used in combination with another medication called enzalutamide. Enzalutamide is a treatment that helps to block the effects of testosterone on prostate cancer cells. The study will also compare this combination to the use of enzalutamide alone or another medication called docetaxel, which is a chemotherapy drug used to treat various types of cancer.

The purpose of the study is to determine if the combination of PF-06821497 and enzalutamide is more effective in prolonging the time patients live without their cancer getting worse, compared to enzalutamide or docetaxel alone. Participants in the study will be randomly assigned to receive either the combination of PF-06821497 and enzalutamide, enzalutamide alone, or docetaxel. The study will involve taking medications in the form of tablets or capsules, and for those receiving docetaxel, it will be administered as an infusion into a vein. The study will last for several weeks, and participants will have regular check-ups to monitor their health and the progress of their cancer.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they may experience. The study aims to provide valuable information on the effectiveness and safety of the new treatment combination for men with metastatic castration-resistant prostate cancer who have previously been treated with another medication called abiraterone acetate. This research could potentially lead to new treatment options for patients with this challenging form of prostate 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

    Initial assessment

    Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to ensure you meet the study criteria.

    You will be asked to provide consent to participate in the study, acknowledging that you understand the procedures and potential risks involved.

  2. Step 2

    Randomization

    After the initial assessment, you will be randomly assigned to one of the treatment groups. This means you will either receive the investigational medicine PF-06821497 in combination with enzalutamide, enzalutamide alone, or docetaxel.

    The assignment is random to ensure fairness and scientific accuracy.

  3. Step 3

    Treatment administration

    If you are assigned to the PF-06821497 and enzalutamide group, you will take PF-06821497 orally in tablet form and enzalutamide as soft capsules. The specific dosage and frequency will be provided by the study team.

    If you are in the enzalutamide group, you will take enzalutamide as soft capsules orally.

    If you are in the docetaxel group, you will receive docetaxel intravenously, which means it will be administered through a vein.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This includes blood tests, imaging scans, and other assessments as needed.

    You will be asked to report any side effects or changes in your health to the study team.

  5. Step 5

    Completion of study

    At the end of the study period, you will have a final assessment to evaluate your overall health and the outcomes of the treatment.

    The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who can join the trial?

10 criteria

  • Must be a male participant.
  • Must be at least 18 years old or older.
  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer. If there is no previous diagnosis, a new biopsy (a small tissue sample) is needed to confirm it.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body, either in the bones or soft tissues, as shown by scans like bone scans, CT, or MRI.
  • Must be castrated, either surgically or medically, which means having low levels of testosterone (a male hormone) in the blood.
  • Must have progressive disease, meaning the cancer is getting worse, shown by one or more of the following:
    • Rising levels of PSA (a protein produced by the prostate) in the blood, with at least two increases over a week apart in the last year. The PSA level at the screening must be at least 1 ng/mL if this is the only sign of progression.
    • Progression of soft tissue disease as defined by specific criteria (RECIST v1.1).
    • Progression of bone disease with two or more new bone lesions on a bone scan.
    • Must have recovered from any side effects of previous treatments to a mild level or to the level they were before treatment, except for hair loss or nerve damage in the hands and feet, which are not considered a safety risk.
    • Must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. Must also have a life expectancy of at least 6 months, as judged by the doctor.

Who cannot join the trial?

3 criteria

  • Patients 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.
  • Patients who are not **male**. This study is only for male participants.
  • Patients who are part of a **vulnerable population**. This means groups of people who might need special protection or care, such as children or those unable to make decisions for themselves.
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Investigated drugs

  • PF-06821497 (Mevrometostat)

    is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. This medication is being used in combination with another drug to see if it can improve the outcomes for patients who have already been treated with a medication called abiraterone acetate.

  • Enzalutamide

    is a medication that is already used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this trial, enzalutamide is being used both on its own and in combination with the experimental drug PF-06821497 to see if the combination is more effective than enzalutamide alone.

  • Docetaxel

    is a type of chemotherapy drug that is used to treat various types of cancer, including prostate cancer. It works by stopping cancer cells from dividing and growing. In this study, docetaxel is being compared to the combination of PF-06821497 and enzalutamide to determine which treatment is more effective in prolonging the time patients live without their cancer getting worse.

What is already known about the treatment

  • Mevrometostat

    Mevrometostat is administered orally and is currently being studied in combination with enzalutamide for treating metastatic castration-resistant prostate cancer, a type of cancer that continues to grow despite hormone therapy. This medication is in the clinical trial phase, and researchers are investigating its effectiveness in prolonging the time patients live without their cancer worsening. Mevrometostat works by targeting specific proteins in cancer cells, potentially slowing their growth and spread. It is classified as an investigational drug, meaning it is still under study and not yet approved for general medical use.

  • Enzalutamide

    Enzalutamide is an oral medication used to treat metastatic castration-resistant prostate cancer, a form of prostate cancer that persists despite hormone therapy. It is well-established in medical practice and literature as a treatment option for this condition. Enzalutamide works by blocking the action of male hormones that can promote the growth of cancer cells. It is classified as an androgen receptor inhibitor, which helps to slow down or stop the growth of cancer cells.

  • Docetaxel

    Docetaxel is administered intravenously and is used to treat metastatic castration-resistant prostate cancer, among other cancers. It is a well-known and widely used chemotherapy drug in medical practice. Docetaxel works by interfering with the division of cancer cells, which helps to stop their growth and spread. It is classified as a taxane, a type of chemotherapy that targets rapidly dividing cells.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It is characterized by the spread of cancer cells beyond the prostate gland to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells grow and multiply, often leading to increased pain and other symptoms. Over time, the cancer may become resistant to hormone therapy, which is initially used to control its growth. As the disease advances, patients may experience a range of symptoms related to the spread of cancer, including bone pain and urinary issues. The progression of the disease can vary, with some patients experiencing rapid changes while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511650-50-00Protocol codeC2321014Estimated enrolment600 patientsSponsorPfizer Inc.

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