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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

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.

Interventions

  • Drug: Cabergoline
    • Cabergoline tablet

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.
  • Active Comparator: Control group
    • Serum prolactin level is adjusted to normal range during cabergoline administration.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Time to normalization of serum prolactin level
    • Time Frame: Up to 1 year
    • Record of PRL levels on follow-up visit
  • Change from baseline on tumor volume measured by pituitary MRI
    • Time Frame: 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
    • Time Frame: Up to 3 years
    • Record the Visual field scale on every 6 month follow-up visit,

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jung Hee Kim, Principal Investigator – Seoul National University Hospital
  • Overall Official(s)
    • Jung Hee Kim, M.D, Principal Investigator, Seoul National University Hospital
  • Overall Contact(s)
    • Jung Hyun Lee, 82-2-2072-4073, leejh001515@naver.com

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