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

Primary Purpose

Pituitary Adenoma, Prolactinoma, Pituitary Tumor

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cabergoline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring Prolactinoma, Cabergoline, Recurrence

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence rate within 1 year after cabergoline withdrawal
Record of PRL levels on every 3 month follow-up visit

Secondary Outcome Measures

Time to normalization of serum prolactin level
Record of PRL levels on follow-up visit
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
Change from baseline of visual field defect
Record the Visual field scale on every 6 month follow-up visit,

Full Information

First Posted
January 23, 2018
Last Updated
March 17, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03457389
Brief Title
Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor
Keywords
Prolactinoma, Cabergoline, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One experimental group and one control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Serum prolactin level is adjusted to normal range during cabergoline administration.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
Caverlactin
Intervention Description
Cabergoline tablet
Primary Outcome Measure Information:
Title
Recurrence rate within 1 year after cabergoline withdrawal
Description
Record of PRL levels on every 3 month follow-up visit
Time Frame
From 4 year to 5 years after cabergoline administration
Secondary Outcome Measure Information:
Title
Time to normalization of serum prolactin level
Description
Record of PRL levels on follow-up visit
Time Frame
Up to 1 year
Title
Change from baseline on tumor volume measured by pituitary MRI
Description
Record of he tumor volume from pituitary MRI on every 12-month follow-up visit
Time Frame
Up to 3 years
Title
Change from baseline of visual field defect
Description
Record the Visual field scale on every 6 month follow-up visit,
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Hyun Lee
Phone
82-2-2072-4073
Email
leejh001515@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Hee Kim, M.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Hee Kim, M.D
Email
jhkxingfu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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