Since 2023, the international recommendation is either medication or surgery as first-line therapy for small and well-localised prolactinomas. However, there is a lack of prospective studies comparing outcomes and evaluating quality of life.
Prolactinomas, common pituitary tumours, affect young individuals causing menstrual irregularities, infertility, headaches, and vision problems. Medication (dopamine agonist) is effective but often is needed long-term due to high recurrence rate, facing side effects like fatigue and mood disorders. Recent studies show surgery results in better long-term remission, and surgery is now recommended as equal first-line treatment for well-defined prolactinomas by the international consensus. However, there's still a lack of comprehensive studies comparing surgery to medication.
The purpose of this study is to investigate whether surgical or medical treatment with a dopamine agonist improves long-term outcomes and quality of life in patients with prolactinomas.
Anticipated enrolment close date: 2026
Who can take part
You may be able to take part if you:
- are at least 18 years of age
- Have had an elevated prolactin level in the last 12 months
- Have an MRI demonstrating a pituitary lesion in the last 12 months
- Be able to fill in questionnaires in English
- Regardless of previous/current dopamine agonist use
What's involved
This is an observational study, meaning we will observe and gather information on the outcomes of the treatment you receive for your prolactinoma. You will receive standard care for your prolactinoma – medication or surgery – as decided by you and your treating team. There are no additional blood tests or scans for the study.
Participants will complete questionnaires on topics like their quality of life, anxiety and depression symptoms, treatment side effects and how they are managing at work and home. You will be followed up for 5 years.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.