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

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ClinicalTrials.gov Identifier: NCT03457389
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Jung Hee Kim, 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.

Condition or disease Intervention/treatment Phase
Pituitary Adenoma Prolactinoma Pituitary Tumor Recurrence Tumor Drug: Cabergoline Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One 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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


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 Name: Caverlactin

Active Comparator: Control group
Serum prolactin level is adjusted to normal range during cabergoline administration.
Drug: Cabergoline
Cabergoline tablet
Other Name: Caverlactin




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to normalization of serum prolactin level [ Time Frame: Up to 1 year ]
    Record of PRL levels on follow-up visit

  2. 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

  3. 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,



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457389


Contacts
Contact: Jung Hyun Lee 82-2-2072-4073 leejh001515@naver.com

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jung Hee Kim, M.D Seoul National University Hospital

Responsible Party: Jung Hee Kim, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03457389     History of Changes
Other Study ID Numbers: 1711-119-901
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Jung Hee Kim, Seoul National University Hospital:
Prolactinoma
Cabergoline
Recurrence

Additional relevant MeSH terms:
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Recurrence
Adenoma
Pituitary Diseases
Prolactinoma
Disease Attributes
Pathologic Processes
Hypothalamic Diseases
Brain Diseases
Nervous System Diseases
Endocrine System Diseases
Cabergoline
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action