Pituitary Adenoma, Pituitary Tumor, Prolactinoma, Recurrence Tumor
Conditions
Keywords
Prolactinoma, Cabergoline, Recurrence
Brief summary
The aim of this study is to investigate whether inhibition of serum prolactin levels below normal range during cabergoline administration may reduce the recurrence rate after drug withdrawal in patients with prolactinomas.
Detailed description
Prolactinoma patients will be assigned to a experimental group that maintains serum prolactin levels below 5 ng/mL and a control group that maintains normal serum prolactin levels. After that, cabergoline will be maintained at a therapeutic dose for 130 weeks. After cabergoline is discontinued, patients will be followed up with serum prolactin measurement for 52 weeks.
Interventions
DRUGCabergoline
Cabergoline tablet
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One experimental group and one control group
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, male or female aged 19 years or older * diagnosed with prolactinoma * No previous history of surgery, medication, or radiation therapy
Exclusion criteria
* Invasive prolactinomas except invading cavernous sinus * Taking dopaminergic medications * Taking medications that can affect serum prolactin level (including estrogenic hormone, oral contraceptive drugs, intrauterine devices) * Hyperprolactinemia due to secondary causes * History of pituitary apoplexy within the last 3 months * Patients with mental illness that should avoid dopamine agonists * Patients with history of cardiac valve diseases * Patients with history of pulmonary fibrosis, retroperitoneal fibrosis, and cystic fibrosis * Moderate degree of hepatic or renal insufficiency (IDMS Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR) \<45 ml/min/1.73m2) * Patients with cabergoline hypersensitivity reaction * Pregnant or breast feeding patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate within 1 year after cabergoline withdrawal | From 4 year to 5 years after cabergoline administration | Record of PRL levels on every 3 month follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to normalization of serum prolactin level | Up to 1 year | Record of PRL levels on follow-up visit |
| Change from baseline on tumor volume measured by pituitary MRI | Up to 3 years | Record of he tumor volume from pituitary MRI on every 12-month follow-up visit |
| Change from baseline of visual field defect | Up to 3 years | Record the Visual field scale on every 6 month follow-up visit, |
Countries
South Korea
Contacts
Primary ContactJung Hyun Lee
Outcome results
None listed