Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

NCT02288962 | Active Not Recruiting Phase 3

• 2 other identifiers: 2012/6772012-001338-32
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin. Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.

Conditions

Pituitary Neoplasms; Adenoma

Keywords

dopamine agonists; cabergoline

Outcome Measures

Primary Outcomes (1)

• change in tumour volume during the main study of two years

  This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by ≥ 10 % or ≥ 2 mm shrinkage/growth in at least one dimension)

  2 years

Secondary Outcomes (5)

• need for surgical and/or radiation treatment

  up till 2 years

• changed pituitary function

  up till 2 years

• change in tumour's distance to chiasma opticum in mm

  up till 2 years

• development of cardiac valvulopathy

  up till 2 years

• impulse control disorder

  up till 2 years

Study Arms (2)

cabergoline

EXPERIMENTAL

Target dose for cabergoline is 2 mg/week.The medication is administered in the evening to minimize side effects. If intolerable side effects occur despite this, it may be necessary to treat with a lower dose than 2 mg per week. Treatment scheme: 0.5 mg x 1 per week the first 2 weeks, then 0.5 mg x 2 per week the next 2 weeks, then 1 + 0.5 mg per week the next 2 weeks, then 1 mg x 2 per week (target dose) for the rest of the study

Drug: cabergoline

observation

NO INTERVENTION

visits and controls as usual

Interventions

cabergoline DRUG

Also known as: galastop, FCE 21336, Cabaser, Dostinex, Cabaseril, cabergoline diphosphate

cabergoline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated MRI scans or ≤ 2 mm distance to chiasma opticum, or:
• a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma

You may not qualify if:

• Previous radiation therapy
• Pituitary surgery the last 6 months
• Previous apoplexy/bleeding in the adenoma
• Pregnancy or lactation
• Contraindications for cabergoline treatment (Known cardiac valvular disease, known pulmonal, pericardial or retroperitoneal fibrosis, clinical significant liver insufficiency, use of medications that interact with cabergoline
• unfit to participate due to any other reason

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (3)

Department of Endocrinology, Akershus University hospital

Oslo, Norway

Location

Department of Endocrinology, St. Olavs Hospital

Trondheim, 7006, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Pituitary Neoplasms; Adenoma

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; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sven M Carlsen, prof md

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2); SE (1)