Study of drug interactions between enzalutamide, morphine and edoxaban in patients with prostate cancer

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What is this study about?

This study examines drug interactions in patients with prostate cancer who are taking multiple medications. The study focuses on three medications: enzalutamide (a cancer treatment medication), edoxaban (a blood-thinning medication), and morphine (a pain relief medication). The purpose is to understand how these medications affect each other when taken together, which is important for ensuring safe and effective treatment.

The research looks at how the body processes these medications when they are taken alone versus when they are taken in combination. The study will measure the amount of each medication in the blood over time. This will help determine if any adjustments to medication doses are needed when patients take these drugs together.

For patients who need pain medication, the study will also monitor how well pain is controlled. Throughout the study, healthcare providers will closely monitor participants for any side effects that may occur when these medications are used in combination. The findings will help improve the treatment of patients who need to take these medications at the same time.

1 Initial assessment

Your eligibility for the study will be evaluated based on specific criteria, including having prostate cancer and being at least 18 years old

Your kidney function will be checked to ensure it is stable with clearance above 50ml/min

Your life expectancy should be greater than 3 months

2 Medication groups assignment

You will be assigned to one of the following treatment groups:

Group 1: Edoxaban (30mg or 60mg once daily) with or without enzalutamide

Group 2: Morphine immediate-release (10mg single dose) with or without enzalutamide

Group 3: Morphine extended-release (taken twice daily) with or without enzalutamide

3 Treatment period

All medications will be taken by mouth

Blood samples will be collected to measure drug levels in your body

If you are receiving morphine for pain, your pain levels will be monitored using a numeric rating scale

4 Safety monitoring

Your health will be monitored for any side effects from the combination of medications

Any adverse events will be tracked and recorded according to standardized criteria

5 Study completion

The study is expected to continue until December 31, 2025

The main goal is to understand how these medications interact with each other in your body

Who Can Join the Study?

  • Must be diagnosed with prostate cancer
  • Must either:
    • Be starting or currently taking enzalutamide (a prostate cancer medication) AND taking edoxaban (a blood thinner) at 30mg or 60mg daily
    • OR be willing to take morphine (pain medication) either as:
      • A single 10mg immediate-release dose
      • OR switch from current pain medication to twice-daily extended-release morphine
  • Must be at least 18 years old
  • Must be able and willing to provide written informed consent before screening
  • Must be able to provide blood samples for testing
  • Must have a life expectancy of more than 3 months
  • Must have stable kidney function with renal clearance (kidney filtering ability) greater than 50ml/minute

Who Cannot Join the Study?

  • History of severe allergic reactions to edoxaban (blood-thinning medication) or enzalutamide (prostate cancer treatment)
  • Severe kidney problems (creatinine clearance less than 30 mL/min)
  • Significant liver disease or abnormal liver function tests
  • Active major bleeding or high risk of bleeding
  • Use of strong medications that interact with the study drugs (CYP3A4 inducers or inhibitors)
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • Recent major surgery within the past month
  • Recent stroke or brain bleeding within the past 6 months
  • Active cancer other than prostate cancer
  • History of seizures or brain disorders
  • Unable to swallow oral medications
  • Participation in another clinical trial within the past 30 days
  • Female participants (study is for male participants only)
  • Age under 18 years
  • Unable to provide informed consent

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
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.10.2022

Trial locations

Investigated drugs:

Enzalutamide is a medication used to treat prostate cancer. It works by blocking the effects of testosterone and other male hormones to slow down cancer growth.

Morphine is a strong pain-relieving medication (opioid) that helps manage moderate to severe pain. It works by changing how the body senses and responds to pain.

Edoxaban is a blood-thinning medication that helps prevent blood clots. It belongs to a group of medications called direct oral anticoagulants (DOACs) and works by blocking specific proteins that help blood to clot.

Investigated diseases:

Prostate Cancer – A disease that develops in the prostate gland, which is part of the male reproductive system. It typically grows slowly, starting in the outer parts of the prostate and gradually spreading within the gland. The cancer cells form from normal prostate cells when mutations occur in the DNA. As the disease progresses, cancer cells may break away from the prostate tumor and spread to other parts of the body. The condition is more common in older men and tends to develop gradually over many years.

Trial ID:
2024-517646-34-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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