Comparison of Surgical Treatment versus Cabergoline in Patients with Newly Diagnosed Microprolactinomas

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What is this study about?

This study focuses on patients with microprolactinomas, which are small tumors in the pituitary gland that produce excess amounts of a hormone called prolactin. The research compares two different treatment approaches: surgical removal of the tumor through a procedure called endoscopic endonasal surgery and medical treatment with a drug called cabergoline (Dostinex).

The research aims to determine if surgical treatment works as well as the standard medical treatment in controlling hormone levels. During the study, some patients will receive the medication cabergoline as tablets taken by mouth, while others will undergo surgery to remove the tumor. The medication will be given at a maximum daily dose of 0.5 milligrams, with treatment lasting up to 12 months.

Throughout the study, patients will have their prolactin hormone levels checked through blood tests. They will also undergo magnetic resonance imaging (MRI) scans to monitor the size of the tumor. These evaluations will help determine how well each treatment method works in controlling the condition and reducing the tumor size.

1 Initial medication phase

You will receive cabergoline (Dostinex) tablets for oral use. This medication helps normalize hormone levels in patients with microprolactinomas (small tumors in the pituitary gland that produce excess prolactin).

The treatment period begins in September 2024 and continues for up to 12 months.

2 6-month evaluation

After 6 months of treatment, you will undergo:

A blood test to measure your prolactin levels (taken from a single fasting blood sample)

An MRI scan to measure the size of the tumor

3 12-month evaluation

At the 12-month mark, you will have:

Another blood test to check your prolactin levels (taken from a single fasting blood sample)

A final MRI scan to evaluate the tumor size

Your response to the medication will be assessed based on these results

4 Treatment completion

The study concludes in April 2026

Your final status will be evaluated based on:

Whether your prolactin levels have returned to normal without medication

The change in tumor size compared to the start of treatment

Who Can Join the Study?

Must be at least 18 years old
Must sign an informed consent document to participate in the study
Can be either male or female
Must show signs and symptoms suggesting high prolactin levels (a hormone produced by the pituitary gland)
Must have elevated prolactin levels confirmed by at least 2 separate blood tests and a series of measurements over time
Must not have a condition called macroprolactin (a form of prolactin that does not cause symptoms)
Must not have other conditions or be taking medications that could cause high prolactin levels
Must have evidence of a small tumor in the pituitary gland (maximum size of 10 millimeters) confirmed by MRI with contrast
Must be able to understand the study’s purpose and complete questionnaires independently
Must not have received any previous treatment for high prolactin levels (including medications, surgery, or radiation therapy)

Who Cannot Join the Study?

Age under 18 or over 65 years old
Previous treatment for microprolactinoma (a small tumor in the pituitary gland)
Pregnancy or breastfeeding
History of pituitary surgery (surgery on the small gland at the base of the brain)
Presence of other hormonal disorders
Known allergies to study medications
Active psychiatric conditions requiring medication
Severe liver or kidney disease
Uncontrolled high blood pressure
History of heart disease or abnormal heart rhythm
Current participation in other clinical trials
Inability to provide informed consent
Conditions that may interfere with regular follow-up visits
History of drug or alcohol abuse within the past year
Use of medications that might interact with study drugs

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	02.09.2024

Trial locations

Investigated drugs:

Cabergoline

Cabergoline is a medication used to treat high levels of prolactin hormone in the body. It belongs to a group of drugs called dopamine agonists and works by reducing prolactin production in the brain. This medication is commonly used as a standard treatment for patients with small prolactin-producing tumors (microprolactinomas).

Endoscopic Endonasal Surgery (EES) is a surgical procedure where doctors access and remove the tumor through the nose without making any external cuts. This minimally invasive technique allows surgeons to reach the tumor at the base of the brain through the nasal passages, offering an alternative to medication-based treatment.

Investigated diseases:

Prolactin-producing pituitary tumour

Microprolactinoma – A small, benign tumor that develops in the pituitary gland and produces excess amounts of the hormone prolactin. These tumors are typically less than 10 millimeters in size. The condition causes irregular menstrual periods and milk production in women who are not pregnant or nursing, while in men it can cause reduced sex drive and fertility issues. Microprolactinomas develop slowly and often remain stable in size over many years. The excess prolactin can also lead to decreased estrogen levels in women and testosterone levels in men.

Trial ID:

2024-516383-28-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of Surgical Treatment versus Cabergoline in Patients with Newly Diagnosed Microprolactinomas

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?