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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pituitary Adenoma; Pituitary Tumor; Prolactinoma; Recurrence Tumor
• Intervention / Treatment: Drug: Cabergoline

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 Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung Hyun Lee; Phone Number: 82-2-2072-4073; Email: leejh001515@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Recurrence; Cabergoline; Prolactinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Disease Attributes; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases; Recurrence; Prolactinoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline
• Other Study ID Numbers: 1711-119-901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No