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NCT Number: NCT02288962

Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pituitary Neoplasms Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Supratentorial Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Endocrinology, Akershus University hospital, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Clear indication for surgery at the time of inclusion
  • 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

Treatment and study plan

cabergoline

Drug

Other names: galastop, FCE 21336, Cabaser, Dostinex, Cabaseril, cabergoline diphosphate

Primary outcomes

  1. change in tumour volume during the main study of two years

    Time frame: 2 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)

Secondary outcomes

  1. need for surgical and/or radiation treatment

    Time frame: up till 2 years

  2. changed pituitary function

    Time frame: up till 2 years

    measured by analysis of blood tests, basal and stimulation tests

  3. change in tumour's distance to chiasma opticum in mm

    Time frame: up till 2 years

    as measured by analysis of MRI images

  4. development of cardiac valvulopathy

    Time frame: up till 2 years

    as measured by analysis of echo cardiography

  5. impulse control disorder

    Time frame: up till 2 years

    as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (NFPAs) - a Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2026
Study completion
2028
First posted
Nov 13, 2014
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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