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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03457389

Collaborator

(none)

Enrollment

Location

Arms

82.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Adenoma Prolactinoma Pituitary Tumor Recurrence Tumor	Drug: Cabergoline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One experimental group and one control groupOne experimental group and one control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2018

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.	Drug: Cabergoline Cabergoline tablet Other Names: Caverlactin
Active Comparator: Control group Serum prolactin level is adjusted to normal range during cabergoline administration.	Drug: Cabergoline Cabergoline tablet Other Names: Caverlactin

Arm

Intervention/Treatment

Experimental: Experimental group

Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.

Drug: Cabergoline

Cabergoline tablet

Other Names:

Caverlactin

Active Comparator: Control group

Serum prolactin level is adjusted to normal range during cabergoline administration.

Drug: Cabergoline

Cabergoline tablet

Other Names:

Caverlactin

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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