Not recruiting

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

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
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
Step 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
Step 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
Step 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
Step 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 trial?

9 criteria

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 trial?

15 criteria

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

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Verified sites

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Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands
Stichting Radboud University Medical Center
Verified
Nijmegen, The Netherlands

Trial locations

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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.

What is already known about the treatment

Enzalutamide
An oral anti-androgen medication used primarily in the treatment of prostate cancer, taken as tablets once daily. It works by blocking the effects of testosterone and other male hormones (androgens) on prostate cancer cells, effectively preventing cancer growth and spread. This medication belongs to the class of androgen receptor inhibitors and is commonly prescribed for patients with advanced prostate cancer who have developed resistance to traditional hormone therapy.
Morphine
A powerful opioid pain medication administered orally, intravenously, or through injection for managing severe pain. It works by binding to specific opioid receptors in the brain and spinal cord to reduce pain perception and emotional response to pain. This medication belongs to the class of natural opioid analgesics and is considered one of the gold standards for pain management in severe conditions.
Edoxaban
An oral anticoagulant medication taken as tablets once daily to prevent blood clots and reduce the risk of stroke. It works by directly inhibiting Factor Xa, a key enzyme in the blood clotting process, and belongs to the class of direct oral anticoagulants (DOACs). This medication is commonly used in patients who need blood-thinning therapy and offers a more predictable anticoagulant effect compared to traditional blood thinners.

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.