Recruiting

Study of How Enzalutamide and Apalutamide Affect Dexamethasone Processing in the Body in Patients with Prostate Cancer

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at prostate cancer and how certain medications used to treat this disease might affect the body's processing of another medicine. The study involves patients who are about to start treatment with one of two medications called enzalutamide or apalutamide, which are types of antihormonal therapy that work by blocking male hormones that can help prostate cancer grow. During the study, participants will also receive dexamethasone, which is a type of medicine called a glucocorticoid that helps reduce inflammation and is often used alongside cancer treatments. The purpose of the study is to see how much enzalutamide and apalutamide change the way the body processes dexamethasone when these medicines are taken together.

Participants will receive dexamethasone at different times during the study to measure how much of the medicine stays in the blood. The first measurement will be taken before starting the antihormonal therapy, and then again after the body has adjusted to the regular use of enzalutamide or apalutamide. Blood samples will be collected to measure the amount of dexamethasone present over time, which helps researchers understand if the antihormonal medicines are affecting how the body breaks down the glucocorticoid. Later in the study, participants may receive a higher dose of dexamethasone to see if increasing the amount can make up for any changes caused by the antihormonal treatment.

The study will also look at whether any unwanted effects occur when dexamethasone is given on three separate occasions during the treatment period. Researchers want to understand if the combination of these medicines requires any adjustments to dosing to ensure patients receive the full benefit of their corticosteroid treatment while taking their cancer therapy. The information gathered will help doctors better understand how these medicines interact in the body and whether treatment plans need to be modified when these medications are used together.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial dexamethasone administration and blood sampling
At the start of the trial, you will receive a single dose of dexamethasone, which is a type of corticosteroid medication. This medication will be given either as an injection into your vein or as an infusion.
Blood samples will be collected from you at specific times after receiving dexamethasone. These samples will measure the level of the medication in your blood over time.
Step 2
Beginning antiandrogen treatment
You will start taking your prescribed antiandrogen medication, which will be either apalutamide or enzalutamide. These medications are taken by mouth in tablet form.
Antiandrogens are medications that block the effects of male hormones and are used to treat prostate cancer.
You will continue taking this medication as prescribed by your doctor throughout the trial.
Step 3
Second dexamethasone administration after reaching steady-state
After you have been taking the antiandrogen medication for a period of time sufficient to reach a stable level in your body, you will receive a second single dose of dexamethasone.
This dose will be the same as the first dose you received.
Blood samples will again be collected at specific times to measure the dexamethasone levels in your blood.
Step 4
Third dexamethasone administration with doubled dose
You will receive a third dose of dexamethasone while continuing your antiandrogen treatment.
This dose will be doubled compared to the previous doses you received.
Blood samples will be collected once more at specific times to measure how the doubled dose affects the medication levels in your blood.
The purpose of this step is to determine whether a higher dose of dexamethasone can maintain appropriate medication levels while taking antiandrogen therapy.

Who can join the trial?

6 criteria

You must have been diagnosed with prostate cancer, which is a type of cancer that occurs in the prostate gland in men
You must be planning to start treatment with specific medications called antiandrogens, which are drugs that block male hormones. The specific antiandrogens for this study are enzalutamide or apalutamide
You must be able to understand all the requirements of the study, give your informed consent to participate, and allow the use and sharing of your personal health information
You must have a WHO performance status of 0 or 1, which is a scale that measures how well you can carry out daily activities. A score of 0 means you are fully active without restrictions, and a score of 1 means you have some symptoms but can still do light work
You must be male
You must be an adult

Who cannot join the trial?

7 criteria

Women cannot participate in this study because it is only for male patients
Patients who do not have prostate cancer, which is a type of cancer that affects the prostate gland in men, cannot participate
Children and teenagers cannot participate as the study is designed for adult patients only
Patients who are allergic or have had severe reactions to enzalutamide, apalutamide, or dexamethasone, which are the medications being studied, cannot participate
Patients who are taking medications that may interfere with the study drugs cannot participate
Patients with severe liver or kidney problems cannot participate because these organs help process the medications being tested
Patients with uncontrolled medical conditions that could make the study unsafe cannot participate

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Enzalutamide
is a medication used to treat prostate cancer. It works by blocking the effects of male hormones like testosterone that can help cancer cells grow.
Apalutamide
is a medication used to treat prostate cancer. It works by blocking the effects of male hormones that can fuel the growth of cancer cells.
Dexamethasone
is a corticosteroid medication that reduces inflammation and suppresses the immune system. It is used to treat various conditions including allergic reactions, skin problems, and certain types of cancer.

What is already known about the treatment

Enzalutamide
Enzalutamide is an oral medication taken by mouth in tablet form, used primarily for treating prostate cancer that has spread to other parts of the body or has not responded to other hormone treatments. It works by blocking male hormones called androgens from attaching to cancer cells, which prevents these hormones from signaling the cancer cells to grow and multiply. This medication belongs to a class of drugs called antiandrogens or androgen receptor inhibitors, and it is widely recognized and approved in medical practice as an important treatment option for advanced prostate cancer.
Apalutamide
Apalutamide is an oral medication administered as tablets taken by mouth, prescribed for the treatment of prostate cancer, including cases where the cancer has not yet spread or has become resistant to other hormone therapies. The drug functions by blocking the action of male hormones on prostate cancer cells, preventing these hormones from binding to specific receptors on the cancer cells and stopping them from promoting tumor growth. It is classified as an antiandrogen or androgen receptor inhibitor and is an established treatment approved for use in modern cancer care for patients with various stages of prostate cancer.
Dexamethasone
Dexamethasone is a corticosteroid medication available in multiple forms including tablets, injections, and liquid solutions, used to reduce inflammation and suppress the immune system in various medical conditions. It works by mimicking natural hormones produced by the adrenal glands and affecting multiple pathways in cells to decrease inflammation, allergic reactions, and immune responses throughout the body. This medication belongs to the corticosteroid class of drugs and is widely used in clinical practice for conditions ranging from severe allergies and asthma to certain cancers and autoimmune diseases.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease that occurs when cells in the prostate gland, a small organ in men located below the bladder, begin to grow uncontrollably. The prostate gland produces fluid that forms part of semen. This cancer typically develops slowly and may initially remain confined to the prostate gland. As the disease progresses, cancer cells can spread beyond the prostate to nearby tissues and organs. In more advanced stages, the cancer may spread to lymph nodes, bones, and other parts of the body. The progression of prostate cancer varies greatly among individuals, with some cases growing very slowly over many years while others develop more rapidly.