Cabergoline in the Management of Nonfunctioning Pituitary Adenoma

NCT07034859 | Enrolling By Invitation Phase 4

• 1 other identifier: 202301198MINB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Cabergoline (Dostinex), a dopamine agonist which has been widely used to treat hyperprolactinemia, prolactinoma for many years, works to treat nonfunctioning pituitary adenoma (NFPA) in adults. The main questions it aims to answer are: Does cabergoline reduce the size of NFPA effectively when used as primary therapy? Participants will: Be 1:1 randomized into two groups. Either to take cabergoline or none for 48 weeks, Visit the clinic every 12 weeks for checkups and tests, Undergo scheduled imaging studies, Magnetic Resonance Imaging (MRI) to measure the change of tumor size.

Conditions

Pituitary Adenoma; MRI; RCT

Keywords

cabergoline; nonfunctioning pituitary adenoma; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Proportions of tumor shrinkage after 48 week-treatment

  The tumor volume will be calculated via ITK-SNAP version 3.6.0 at visit 1, 4, 5, 7. The largest diameter of tumor will also be measured at visit 1, 4, 5, 7. The within-group differences were examined by Wilcoxon signed-rank test. The between-group differences were examined by Wilcoxon rank-sum test. The proportion of tumor shrinkage will be examined at visit 7. The between-group differences were examined by McNemar test

  Baseline (Visit 1), 12th Week (Visit 4), 24th Week (Visit 5), 48th Week (Visit 7)

Secondary Outcomes (1)

• Progression-free survival, Largest diameter of tumor, estimated tumor volume

  48th week

Other Outcomes (2)

• The change of tumor diameter (mm)

  Baseline, 48th week

• The change of tumor volume (mm³)

  Baseline, 48th weeks

Study Arms (2)

Participants receiving cabergoline treatment

EXPERIMENTAL

Cabergoline (Dostinex ®) 0.5 mg/tablet. Cabergoline will be given orally 1mg/week (Day1-14), 2mg/week (Day15-end of the study).

Drug: Cabergoline 0.5 MG

Control

NO INTERVENTION

Participants without carbergoline treatment

Interventions

Cabergoline 0.5 MG DRUG

Cabergoline (Dostinex ®) 0.5 mg/tablet. Cabergoline will be given orally 1mg/week (Day1-14), 2mg/week (Day15-end of the study).

Participants receiving cabergoline treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age at Visit 1.
• Documentation of NFPA as evidenced by diagnostic criteria and size ≥ 0.5 cm in diameter.
• Absence of previous hormonal pituitary hypersecretion, except prolactin level ≤ 30 ng/ml
• Absence of previous radiotherapy or radiosurgery
• Written informed consent

You may not qualify if:

• Allergic to cabergoline or ergotamine
• Currently receiving cabergoline
• With moderate to severe symptoms of mass effect, such as visual defect, headache, cranial nerve palsy.
• AST, ALT over 2.5 times of the upper limit.
• Chronic kidney disease, stage 4 and 5.
• Hypotension
• History of congestive heart failure, NYHA Fc III, IV
• History of moderate or severe valvular heart disease.
• History of Parkinson's disease.
• History of pulmonary fibrosis
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• History of previous pituitary surgery or radiotherapy
• Psychotic psychiatric disease
• Active gastrointestinal tract bleeding
• History of Raynaud's phenomenon

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Beihu Branch: collaborator
• National Taiwan University: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• National Taiwan University Hospital, Yun-Lin Branch: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 24, 2025
• Study Start: May 20, 2024
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)