Surgical versus Medical Treatment in Microprolactinomas (SUMET PRO)
This study, called SUMET PRO, is looking into the best way to treat tiny, non-cancerous growths on a gland in your brain called the pituitary gland. These growths, known as microprolactinomas, can cause your body to make too much of a hormone called prolactin. The study compares two main approaches: surgery to remove the growth, or taking a medication called Dostinex (cabergoline). Researchers will test prolactin levels in your blood and use MRI scans to see how well each treatment works at lowering prolactin and shrinking the growth over 6 to 12 months. This is a Phase III study, meaning it's a key step to confirm how effective these treatments are.
At a glance
What is this study about?
This research study, named SUMET PRO, is focused on a condition called microprolactinomas. These are very small, usually harmless, growths that can develop on your pituitary gland, a small gland located at the base of your brain. The pituitary gland is important because it produces many hormones that control different body functions. When you have a microprolactinoma, it often causes your body to make too much of a hormone called prolactin. High prolactin levels can lead to various symptoms in both men and women.
The main goal of this study is to compare two common ways of treating microprolactinomas: surgery to remove the growth, and taking a medication called Dostinex (which contains the active ingredient cabergoline). Doctors want to find out which method is more effective at bringing prolactin levels back to normal and reducing the size of the growth. They will be carefully checking participants' prolactin levels and using special scans to see the changes.
Over 6 to 12 months, the researchers will closely monitor how each treatment works. They will look at how many people achieve 'biochemical remission' – meaning their prolactin levels return to a healthy range. They will also use MRI scans to see if the growths are shrinking. This type of research helps doctors understand the best way to help patients with microprolactinomas, aiming to improve lives by finding the most successful treatment options.
Key takeaways
- This study compares surgery and a medication called Dostinex for treating microprolactinomas.
- It aims to find out which treatment is better at lowering prolactin and shrinking the growth.
- Participation involves blood tests and MRI scans over a 12-month period.
- Only people aged 18 and over with a microprolactinoma can join.
- You can stop participating in the study at any time.
Who may be eligible?
To be able to take part in this study, you must be at least 18 years old. The study is open to both men and women.
This study is specifically for people who have been diagnosed with microprolactinomas. These are small, non-cancerous growths on the pituitary gland that cause your body to make too much of a hormone called prolactin.
More detailed information about who can and cannot join will be available from the study team. They will need to check your medical history and current health to make sure the study is right for you and safe for you to participate in.
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 18 years old or older?
- Have you been diagnosed with a microprolactinoma?
- Are you able to attend regular appointments for blood tests?
- Are you able to have MRI scans?
- Are you able to consent to participate and understand the study requirements?
What does participation involve?
If you decide to take part in this study, you would primarily be involved in regular check-ups to monitor your progress. This will include having your blood taken to measure your prolactin levels. These blood tests will happen when you start the study, then again at 6 months, and finally at 12 months.
You will also have special scans called MRI scans with contrast. These scans help doctors see the pituitary gland and measure the size of the growth. You will have an MRI at the beginning of the study, and then again at 6 months and 12 months.
Depending on which treatment group you are in, you will either undergo surgery or start taking the medication Dostinex. If you are taking Dostinex, doctors will also check if the medication is working well and if you're taking the highest dose you can tolerate without too many side effects. The total duration of your active participation in measuring the treatment's effects will be for 12 months.
Potential risks and benefits
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Common questions
What is a microprolactinoma?
It's a very small, harmless growth on your pituitary gland that can cause your body to make too much prolactin hormone.
What is Dostinex?
Dostinex is a medication (also known as Cabergoline) that helps lower high levels of the prolactin hormone in your body.
Why are they doing this study?
Doctors want to find out whether surgery or Dostinex medication is the best way to treat microprolactinomas by lowering prolactin and shrinking the growth.
How long will I be in the study?
The main part of the study where your prolactin levels and growth size are checked will last for 12 months.
What exams will I have?
You'll have blood tests to check prolactin levels and MRI scans to look at the growth at the start, 6 months, and 12 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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