Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

NCT ID: NCT02288962

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cabergoline

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

Group Type: EXPERIMENTAL

cabergoline

Intervention Type: DRUG

observation

visits and controls as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cabergoline

Intervention Type: DRUG

Other Intervention Names

galastop; FCE 21336; Cabaser; Dostinex; Cabaseril; cabergoline diphosphate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sven M Carlsen, prof md

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Department of Endocrinology, Akershus University hospital

Oslo, , Norway

Department of Endocrinology, St. Olavs Hospital

Trondheim, , Norway

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Norway; Sweden

Other Identifiers

2012-001338-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/677

Identifier Type: -

Identifier Source: org_study_id