Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma: A Prospective, Randomized, Open Label, Active-controlled, Clinical Trial

Conditions
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Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor

Intervention / Treatment
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* Drug: Cabergoline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One experimental group and one control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration. | Drug: Cabergoline<br>* Cabergoline tablet<br>* Other names: Caverlactin;|
| Active Comparator: Control group<br>Serum prolactin level is adjusted to normal range during cabergoline administration. | Drug: Cabergoline<br>* Cabergoline tablet<br>* Other names: Caverlactin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate within 1 year after cabergoline withdrawal | Record of PRL levels on every 3 month follow-up visit | From 4 year to 5 years after cabergoline administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to normalization of serum prolactin level | Record of PRL levels on follow-up visit | Up to 1 year | 
| Change from baseline on tumor volume measured by pituitary MRI | Record of he tumor volume from pituitary MRI on every 12-month follow-up visit | Up to 3 years | 
| Change from baseline of visual field defect | Record the Visual field scale on every 6 month follow-up visit, | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolactinoma, Cabergoline, Recurrence