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

Not Applicable

Recruiting

• Conditions: Pituitary Adenoma; Pituitary Tumor; Recurrence Tumor; Prolactinoma
• Interventions: Drug: Cabergoline

• Registration Number: NCT03457389
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-23
• Study Start: 2018-02-22
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Status Verified: 2019-09
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Cabergoline	Serum prolactin level is adjusted to normal range during cabergoline administration.
Experimental group	Cabergoline	Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Time to normalization of serum prolactin level	Up to 1 year	Record of PRL levels on 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,

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of