Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288962
• Other study ID #: 2012/677
• Secondary ID: 2012-001338-32
• Status: Recruiting
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: December 2027

Study information

• Verified date: January 2023
• Source: St. Olavs Hospital
• Contact: Stine L Fougner, md phd
• Email: stine.fougner[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• cabergoline

Locations

Country	Name	City	State
Norway	Department of Endocrinology, Akershus University hospital	Oslo
Norway	Department of Endocrinology, St. Olavs Hospital	Trondheim
Sweden	Sahlgrenska University Hospital	Gøteborg

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	need for surgical and/or radiation treatment		up till 2 years
Secondary	changed pituitary function	measured by analysis of blood tests, basal and stimulation tests	up till 2 years
Secondary	change in tumour's distance to chiasma opticum in mm	as measured by analysis of MRI images	up till 2 years
Secondary	development of cardiac valvulopathy	as measured by analysis of echo cardiography	up till 2 years
Secondary	impulse control disorder	as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry	up till 2 years