Not recruiting

Study of enzalutamide compared to bicalutamide and flutamide in first-line treatment for patients with metastatic prostate cancer

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 study focuses on metastatic prostate cancer, a condition where cancer that started in the prostate has spread to other parts of the body. The main treatment being tested is enzalutamide, which is compared to other medications called flutamide and bicalutamide. These medications belong to a group of drugs known as androgen receptor blockers, which work by blocking the effects of male hormones in the body.

The purpose of this research is to determine if enzalutamide, when used as an initial treatment together with standard hormone therapy, can help patients with metastatic prostate cancer live longer. The study compares enzalutamide to other similar medications that are currently used to treat this type of cancer.

During the study, participants receive either enzalutamide soft capsules (160 mg daily), flutamide tablets (750 mg daily), or bicalutamide tablets (50 mg daily). The treatment continues for up to 120 months, with regular check-ups to monitor the patient's health status and how well the treatment is working. All medications are taken by mouth.

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 qualification
You will undergo initial evaluation to confirm your eligibility for the study. This includes verification that you are a male aged 18 or older with metastatic prostate cancer.
Your doctor will check if you meet the required health parameters, including adequate blood cell counts, liver function, and kidney function.
Your overall physical condition will be assessed using a special scale called ECOG performance status, which must be between 0-2.
Step 2
Treatment assignment
You will be randomly assigned to receive one of the following oral medications:
Option 1: Xtandi (enzalutamide) 40 mg soft capsules
Option 2: Either Flutamide 250 mg tablets or Casodex (bicalutamide) 50 mg film-coated tablets
Treatment must begin within 7 days after being assigned to your medication group
Step 3
Regular monitoring
Your condition will be regularly monitored through several methods:
Blood tests to check PSA levels (prostate-specific antigen)
Imaging scans to track disease progression
Assessment of any side effects using standardized criteria
Quality of life questionnaires to evaluate your well-being
Step 4
Long-term follow-up
The study continues until December 2026
Regular evaluations will track your overall survival and disease progression
Your quality of life and any treatment-related side effects will be monitored throughout the study period

Who can join the trial?

10 criteria

Must be a male aged 18 or older with confirmed metastatic prostate cancer (cancer that has spread beyond the prostate), proven by either: - A tissue sample from a site where cancer has spread - A prostate tissue sample plus evidence of cancer spread - Typical spread to bones or lymph nodes with rising PSA levels above 20ng/mL (PSA is a protein indicating prostate cancer activity)
Must provide signed written consent to participate
Must have measurable cancer lesions that can be monitored during the study
Must have adequate blood test results showing: - Hemoglobin level of at least 100g/L - White blood cell count of at least 4.0 x 109/L - Platelet count of at least 100 x 109/L
Must have adequate liver function shown by blood tests: - ALT (liver enzyme) less than 2 times normal limit - Bilirubin (liver function indicator) less than 1.5 times normal limit
Must have adequate kidney function with creatinine clearance above 30 ml/min
Must have good overall physical function (ECOG score 0-2). A score of 2 is only accepted if decreased function is due to prostate cancer
Must be able to start treatment within 7 days after being assigned to study group
Must be willing and able to follow all study requirements and attend appointments
Must complete quality of life questionnaires (unless unable due to vision problems or reading difficulties)

Who cannot join the trial?

14 criteria

Prior history of chemotherapy (treatment using drugs to destroy cancer cells) for prostate cancer
Presence of active brain metastases (cancer that has spread to the brain)
History of another type of cancer within the past 5 years, except for successfully treated non-melanoma skin cancer
Severe heart conditions, including heart failure or uncontrolled high blood pressure
Significant liver problems or abnormal liver function tests
Serious active infections, including HIV or Hepatitis B or C
Any condition that could interfere with taking oral medications
Current participation in other clinical trials
Known allergies to the study medications or their components
Major surgery within 4 weeks before starting the study
Mental conditions that could affect ability to provide informed consent
Female patients (study is designed for male patients only)
Age under 18 years
Inability to follow study procedures or attend scheduled visits

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Verified sites

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

St Vincent's University Hospital
Verified
Dublin, Ireland
University Hospital Galway
Verified
Galway, Ireland

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Investigated drugs

Enzalutamide
is a medication used to treat prostate cancer. It works by blocking the effects of male hormones (androgens) in the body. This helps slow down or stop the growth of prostate cancer cells. It is taken as an oral medication in the form of tablets.
Androgen Deprivation Therapy (ADT)
is a treatment that reduces the levels of male hormones in the body. This therapy can be achieved through different medications or surgical procedures. It is a standard treatment approach for metastatic prostate cancer that works by depriving cancer cells of the hormones they need to grow.

What is already known about the treatment

Enzalutamide - An oral medication used in the treatment of metastatic prostate cancer, administered in tablet form once daily. This drug belongs to the class of second-generation androgen receptor inhibitors and works by blocking the effects of testosterone and other male hormones on prostate cancer cells, effectively preventing cancer growth and spread. Enzalutamide has shown significant effectiveness in clinical trials for treating metastatic prostate cancer, particularly when used in combination with androgen deprivation therapy as a first-line treatment option. The medication has been approved by major regulatory agencies and is well-documented in medical literature as a standard treatment option for advanced prostate cancer.

Investigated diseases

Metastatic Prostate Cancer - A condition where prostate cancer cells have spread beyond the prostate gland to other parts of the body. The cancer typically begins in the prostate gland and then spreads through the bloodstream or lymphatic system to other organs, most commonly to bones, lymph nodes, and other organs. As the disease progresses, cancer cells continue to grow and multiply in their new locations, forming new tumors. The condition develops gradually, often over months or years, and may cause various symptoms depending on where the cancer has spread. The disease affects the body's hormone system, particularly the way it responds to testosterone.