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

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What is this study about?

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.

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.

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
University Hospital Waterford Waterford Ireland
University Hospital Galway Galway Ireland
Beaumont Hospital Dublin Ireland
Mater Private Hospital Dublin Ireland
Sn Vsmppytcpsmdnps Uktiwhxfft Hjzjdcgs Dublin Ireland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Ireland Ireland
Not recruiting
09.01.2015

Trial locations

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.

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.

Trial ID:
2024-516137-13-00
Protocol code:
CTRIAL-IE 14-06
NCT ID:
NCT02446405
Trial Phase:
Therapeutic confirmatory (Phase III)

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