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

NCT03457389 — Not applicable, Unknown, 68 participants, Seoul National University Hospital

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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

Registry	NCT03457389
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	68 (Estimated)
Sponsor	Seoul National University Hospital (Other)
Conditions	Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor
Interventions	Cabergoline (Drug)
Dates	start 2018-02-22, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2018-03-07, last updated 2020-03-18
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Experimental group	Experimental	Drug: Cabergoline	Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.
Control group	Active comparator	Drug: Cabergoline	Serum prolactin level is adjusted to normal range during cabergoline administration.

Cabergoline (Drug), also known as Caverlactin: Cabergoline tablet

+Outcome measures

Primary outcomes

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 outcomes

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,

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea	Recruiting

+Investigators

Jung Hee Kim, M.D, Principal investigator, Seoul National University Hospital

My Notes

Public

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