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Study on Enzalutamide and Drug Combination for High-Risk Localized Prostate Cancer Patients

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 treatments for prostate cancer, specifically in cases where the cancer is localized but at high risk of coming back. The study involves the use of several medications that block androgen receptors, which are proteins in the body that can promote the growth of prostate cancer cells. The medications being tested include Enzalutamide (known by the brand name Xtandi), Nilutamide (known as Anandron), Bicalutamide (known as Casodex), and Flutamide. These medications are taken orally in the form of tablets or capsules.

The purpose of the study is to determine the effects of these treatments on the time patients remain free from cancer spreading to other parts of the body or dying from any cause. Participants in the study will receive one of these medications, and some may receive a placebo. The study will also involve radiation therapy as part of the treatment plan. The trial will last for a period of time, during which participants will be monitored regularly to assess their health and the effectiveness of the treatment.

Throughout the study, researchers will collect information on various outcomes, such as overall survival, the time until the cancer progresses, and the safety of the treatments. They will also evaluate the quality of life of participants and the cost-effectiveness of the treatments. This information will help in understanding how well these medications work in treating high-risk localized prostate cancer and their impact on patients' lives.

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, the patient will be randomly assigned to a treatment group. This process is known as randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.
Step 2
Treatment initiation
The treatment will begin within 7 days of randomization. The patient will receive one of the following medications orally: nilutamide (150 mg tablet), enzalutamide (40 mg soft capsule), bicalutamide (50 mg film-coated tablet), or flutamide (250 mg tablet).
The specific dosage and frequency of administration will depend on the medication assigned during randomization.
Step 3
Radiation therapy
In addition to the medication, the patient will undergo radiation therapy. This therapy is part of the treatment plan for high-risk, localized prostate cancer.
Step 4
Ongoing assessments
Throughout the trial, the patient will attend regular assessments to monitor health and response to treatment. These assessments will include imaging tests, blood tests, and questionnaires about health-related quality of life.
The assessments aim to track the progression of the disease and any side effects from the treatment.
Step 5
Completion of the trial
The trial is expected to continue until December 31, 2025. The patient will remain in the study until this date or until the treatment is no longer beneficial.
The primary goal is to determine the effects on metastasis-free survival, which means the time until the cancer spreads or the patient passes away from any cause.

Who can join the trial?

10 criteria

Must have a confirmed diagnosis of **adenocarcinoma of the prostate**, which is a type of prostate cancer, and be at high risk for the cancer coming back. This is determined by specific medical criteria such as a **Gleason score** (a system to grade prostate cancer) of 8-10, or a score of 4+3 with certain other conditions, or cancer spread to lymph nodes.
Must provide **signed, written, informed consent**, which means agreeing to participate in the study after being fully informed about it.
Must be **18 years or older**.
Must have **adequate bone marrow function**, which means having enough healthy blood cells. This is measured by specific blood tests.
Must have **adequate liver function**, meaning the liver is working well enough, as shown by certain blood tests.
Must have **adequate kidney function**, which means the kidneys are working well enough, as shown by a test called **creatinine clearance**.
Must have an **ECOG performance status** of 0-1, which is a scale used to assess how well a person can perform daily activities.
Must be able to start the study treatment within **7 days of being assigned** to a treatment group.
Must be **willing and able to follow all study requirements**, including taking the treatment and attending necessary check-ups.
Must have completed the initial **Health-Related Quality of Life (HRQL) questionnaires**, unless unable to do so due to reading or vision difficulties.

Who cannot join the trial?

4 criteria

Only men can participate in this study. Women are not eligible.
Participants must have localized prostate cancer that is at high risk of coming back after treatment.
Participants should be within certain age ranges, typically adults and older adults.
Individuals who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

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

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Cork University Hospital
Cork, Ireland
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Institut Catala D'oncologia
L'hospitalet De Llobregat, Spain
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Uniklinikum Salzburg
Salzburg, Austria

Trial locations

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Investigated drugs

Enzalutamide
is a medication used in this trial to treat prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. This medication is being tested to see if it can improve survival without the cancer spreading to other parts of the body.
Androgen Deprivation Therapy (ADT)
is a treatment that reduces the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so lowering their levels can help control the cancer.
Radiation Therapy
is a treatment that uses high-energy rays to kill cancer cells. In this trial, it is used alongside other treatments to target and destroy prostate cancer cells.

What is already known about the treatment

Enzalutamide – Enzalutamide is administered orally in the form of capsules or tablets. It is currently used in the treatment of prostate cancer, particularly in cases that are at high risk of recurrence. The medication works by blocking the action of androgens, which are male hormones that can promote the growth of cancer cells. Enzalutamide is classified as an androgen receptor inhibitor, and it is well-documented in medical literature for its role in improving survival rates in prostate cancer patients.

Investigated diseases

Localized Prostate Cancer at High Risk of Recurrence – This form of prostate cancer is confined to the prostate gland but has a high likelihood of returning after initial treatment. It is characterized by cancer cells that have not yet spread to distant parts of the body but may invade nearby tissues. The progression of this disease can vary, with some cases remaining stable for years, while others may advance more rapidly. Factors such as tumor size, grade, and PSA levels can influence the risk of recurrence. Monitoring and regular check-ups are essential to track any changes in the condition.