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Study of Pembrolizumab and Enzalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer

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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 cancer known as metastatic hormone-sensitive prostate cancer. This is a form of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The study is testing a combination of treatments to see how effective they are in managing this disease. The treatments being studied include pembrolizumab, also known by its code name MK-3475, and enzalutamide, along with a standard treatment called androgen deprivation therapy (ADT). Pembrolizumab is given as an infusion into a vein, while enzalutamide is taken orally.

The purpose of the study is to compare the effects of pembrolizumab plus enzalutamide and ADT against a placebo plus enzalutamide and ADT. Participants will be randomly assigned to receive either the active treatment or the placebo. The study will monitor how the cancer responds to these treatments over time, focusing on how long participants live without the cancer getting worse and overall survival rates. The trial will also look at other factors, such as the time it takes for the cancer to start growing again and any side effects experienced by participants.

Participants in the study will receive treatment for up to two years, with regular check-ups and assessments to track their progress. The study aims to provide valuable information on whether the combination of pembrolizumab and enzalutamide can offer better outcomes for patients with metastatic hormone-sensitive prostate cancer compared to the current standard treatment options. This research could potentially lead to improved treatment strategies for this type of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the study medication pembrolizumab along with enzalutamide and androgen deprivation therapy (ADT). The other group will receive a placebo instead of pembrolizumab, along with enzalutamide and ADT.
Step 2
Medication administration
If you are in the group receiving pembrolizumab, it will be administered through an intravenous infusion. This means the medication will be given directly into your vein. The frequency and dosage will be determined by the study team.
You will also take enzalutamide orally, which means you will swallow the medication in pill form. The dosage and frequency will be specified by the study team.
Step 3
Ongoing treatment
Throughout the study, you will continue to receive ADT, which is a treatment to lower the levels of male hormones in your body. This can be done through medication or, if you have had a bilateral orchiectomy, you will not need additional ADT.
Step 4
Regular assessments
You will undergo regular assessments to monitor your health and the effects of the treatment. This includes imaging tests like CT or MRI scans to check the status of your cancer, as well as blood tests to measure prostate-specific antigen (PSA) levels.
Step 5
End of treatment
The study is expected to continue until July 2026. Your participation may end earlier if you experience significant side effects, if your cancer progresses, or if you choose to withdraw from the study.

Who can join the trial?

10 criteria

Must be a male participant.
Must have a confirmed diagnosis of prostate cancer that has spread to other parts of the body.
Must have at least two bone lesions or disease in other organs as shown by a scan.
Must be willing to continue hormone therapy during the study or have had surgery to remove both testicles.
Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
If receiving treatment to prevent bone loss, must have been on stable doses before starting the study.
Must have adequate organ function, meaning the organs are working well enough.
Must provide a new biopsy sample from a tumor that has not been treated with radiation in the past, unless the tumor is growing in a previously treated area. If the disease is mainly in the bones, a bone biopsy is acceptable.
Must agree not to donate sperm and either abstain from heterosexual intercourse or use contraception during the study and for at least 120 days after the last dose, unless confirmed to be unable to produce sperm.
Must agree to use a male condom during any activity that allows for the passage of ejaculate to another person.

Who cannot join the trial?

3 criteria

Patients who have a different type of cancer other than metastatic hormone sensitive prostate cancer.
Patients who are not male.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
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Aalborg, Denmark
Cork University Hospital
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Cork, Ireland
Herlev Hospital
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Herlev, Denmark

Trial locations

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Investigated drugs

Pembrolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help treat prostate cancer that has spread to other parts of the body and is sensitive to hormone therapy.
Enzalutamide
is a medication used to treat prostate cancer. It works by blocking the effects of male hormones, like testosterone, which can help slow the growth of cancer cells. In this trial, enzalutamide is used in combination with other treatments to see if it can improve outcomes for patients with metastatic hormone-sensitive prostate cancer.
ADT
, or Androgen Deprivation Therapy, is a treatment that reduces the levels of male hormones in the body. These hormones can promote the growth of prostate cancer cells. ADT is used in this trial to help control the cancer and is combined with other medications to see if it can enhance the treatment's effectiveness.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic hormone-sensitive prostate cancer. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and fight cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.
Enzalutamide
Enzalutamide is taken orally in the form of a capsule or tablet. It is an established medication used in the treatment of metastatic hormone-sensitive prostate cancer. The primary therapeutic indication for enzalutamide is to inhibit the growth of prostate cancer cells. It works by blocking the action of male hormones, like testosterone, which can promote the growth of cancer cells. Enzalutamide is classified as an androgen receptor inhibitor, which is a type of hormone therapy.

Investigated diseases

Metastatic Hormone-Sensitive Prostate Cancer – This disease is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. It begins in the prostate gland and can metastasize to bones, lymph nodes, or other organs. The cancer cells continue to grow and divide, but their growth can be slowed by reducing levels of male hormones like testosterone. Over time, the cancer may become less responsive to hormone therapy, leading to further progression. Symptoms can include difficulty urinating, bone pain, and fatigue. The disease is monitored through imaging tests and prostate-specific antigen (PSA) levels to assess its progression.