Surgical versus Medical Treatment in Microprolactinomas (SUMET PRO)

Phase 1

• Conditions: Microprolactinomas; MedDRA version: 20.1Level: PTClassification code 10036831Term: Prolactin-producing pituitary tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2023-000082-13-IT
• Lead Sponsor: AZIENDA USL DI BOLOGNA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-06
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

- age > 18 years old
- male or female gender
- clinical manifestations suggestive for hyperprolactinemia
- prolactin levels above upper lower limits confirmed at >2 single determinations, and at serial
determinations (prolactin curve)
- exclusion of macroprolactin
- exclusion of other endogenous or iatrogenic causes of hyperprolactinemia, according to the
Endocrine Society Guidelines
- evidence of a pituitary adenoma with maximum diameter = 10 mm (m-PRL) at the MRI with g.c.m.
- patient able to understand the study purpose, to give informed written consent, and to respond to
self-administered questionnaires
- no previous medical, surgical or radiation treatment for hyperprolactinemia
- signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- contraindications to general anesthesia or surgery
- contraindications to CAB
- pregnancy at the time of randomization
- clinical and/or biochemical evidence of concomitant secretion of other pituitary hormones (i.e., GH,
TSH, FSH/LH and/or ACTH) by the microadenoma
- prior surgery or radiotherapy to the skull base and/or hypothalamic-pituitary area
- prior CAB treatment
- concomitant treatment with other dopamine agonists
- patient unable to understand the study purpose and/or to give informed written consent and/or to
respond to self-administered questionnaires
- other medical conditions that to the opinion of physicians are not compatible with inclusion in a trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified