A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
This study is for older men with advanced prostate cancer. We're looking at a common drug called enzalutamide. While it works well, some older men (over 75) find the usual dose causes more side effects like feeling very tired or having trouble thinking clearly. These side effects can really affect how they live their daily lives. Doctors sometimes lower the dose for older patients, but we don't have much research on whether a lower dose works just as well with fewer side effects. We want to understand how the body of an older man handles this drug differently. Our goal is to find the best dose that helps treat the cancer while keeping side effects to a minimum, helping older men feel better and have a better quality of life.
At a glance
What is this study about?
This study is looking into a medication called enzalutamide, which is widely used to treat advanced prostate cancer. We know it's a good drug that helps many people, but for some older men, especially those over 75, the standard dose might cause more side effects. These can include feeling very tired or having some trouble with memory or clear thinking. These kinds of side effects can make a big difference to how someone feels day-to-day and how they enjoy their life.
Because of this, doctors sometimes decide to give older patients a lower dose of enzalutamide. However, there hasn't been much research to clearly show if a lower dose is just as effective at treating the cancer while also reducing these difficult side effects. This study aims to fill that gap. We want to understand exactly how an older person's body processes enzalutamide compared to younger people.
By carefully studying how the drug works in the body at different doses, we hope to find out if specific dosing tailored for older men is a better approach. The ultimate goal is to make sure that older men with prostate cancer get the best possible treatment, one that not only fights the cancer effectively but also helps them maintain their quality of life with fewer unwanted side effects.
Key takeaways
- A study for older men (75+) with advanced prostate cancer.
- Looking for the best dose of enzalutamide to reduce side effects.
- Helps understand how elderly bodies process medication.
- Aims to improve quality of life for older patients.
- Compares different doses to the standard treatment.
- Requires regular blood tests and participation in questionnaires.
Who may be eligible?
This study is mainly looking for men aged 75 or older who have advanced prostate cancer and are currently taking or about to start taking enzalutamide. You'll need to have a specific type of prostate cancer that responds to this kind of treatment, and also be on other hormone therapy or have had a certain procedure.
We also need a small group of control patients who are under 70 years old, also receiving enzalutamide for advanced prostate cancer, and have been on a steady dose for at least 29 days. This helps us compare how the drug works in different age groups.
You wouldn't be able to join if your prostate cancer has spread to your bones in a way that is causing severe pain or if there's a risk of your spinal cord being pressed. Also, if you're taking certain other medications that might interfere with enzalutamide, you wouldn't be eligible. The study is only open to men (the information says 'FEMALE' but this is an error in the original document, as prostate cancer affects males).
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man aged 75 or older?
- Do you have advanced prostate cancer and are you taking or starting enzalutamide?
- Are you also on other hormone therapy or had a specific procedure for prostate cancer?
- Do you feel capable of attending regular appointments and providing blood samples?
- Do you have specific types of prostate cancer that don't include widespread bone pain or spinal cord risk?
- Are you not taking medications that might interfere with enzalutamide?
What does participation involve?
If you join this study, you will be given specific doses of enzalutamide. Throughout the study, you'll have regular hospital visits for check-ups. This will involve giving blood samples so doctors can see how your body is handling the medication. We'll also ask you to fill out questionnaires about how you're feeling and your quality of life. The study will last for a certain period, and the medical team will explain the full schedule to you.
Potential risks and benefits
Locations (1)
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada
Common questions
What is enzalutamide?
Enzalutamide is a medicine used to treat advanced prostate cancer. It works by blocking certain hormones that help cancer grow.
Why is this study only for older men?
We've noticed that older men, especially those over 75, sometimes experience more side effects from the usual dose of enzalutamide. This study wants to find a dose with fewer side effects for them.
Will I get a different dose of enzalutamide?
Yes, if you're in the main group, you might receive different doses of enzalutamide as part of the study to help us find the best level.
What kind of side effects are you looking at?
We're particularly interested in side effects like feeling very tired (fatigue) or having trouble with memory or clear thinking, as these can significantly impact daily life.
How long will I be in the study?
The study team will explain the exact duration of your participation, including all visits and follow-ups.
How to find out more
Daniel Khalaf, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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