Cabergoline for Microprolactinoma|Prolactin-producing pituitary tumour

Inclusion criteria

• {"criterion_text":"- age > 18 years old"}
• {"criterion_text":"- signed informed consent"}
• {"criterion_text":"- male or female gender"}
• {"criterion_text":"- clinical manifestations suggestive for hyperprolactinemia"}
• {"criterion_text":"- prolactin levels above upper lower limits confirmed at >2 single determinations, and at serial determinations (prolactin curve)"}
• {"criterion_text":"- exclusion of macroprolactin"}
• {"criterion_text":"- exclusion of other endogenous or iatrogenic causes of hyperprolactinemia, according to the Endocrine Society Guidelines"}
• {"criterion_text":"- evidence of a pituitary adenoma with maximum diameter = 10 mm (m-PRL) at the MRI with g.c.m."}
• {"criterion_text":"- patient able to understand the study purpose, to give informed written consent, and to respond to self-administered questionnaires"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Prolactin levels will be measured on single fasting venous sampling at 6- and 12-month follow up to determine the rate of biochemical remission in patients treated with EES or CAB","definition_or_measurement_approach":"Prolactin measured on single fasting venous sampling at 6 and 12 months to determine rate of biochemical remission; main objective defines biochemical remission as prolactin normalization in the absence of treatment."}

Secondary endpoints

• {"endpoint_text":"- To determine m-PRL remnant at MRI with g.c.m. performed at 6 and 12 months after EES or starting CAB. MRI with g.c.m will be performed at study enrollment (baseline) and at 6- and 12- month follow-up to evaluate m-PRL diameters, so the ability of EES and CAB to reduce tumor mass.","definition_or_measurement_approach":"MRI with gadolinium contrast (g.c.m.) at baseline, 6 and 12 months to evaluate m-PRL diameters and remnant/tumor mass."}
• {"endpoint_text":"- To determine in patients treated with CAB the rate of drug resistance (defined as failure to achieve normal prolactin levels and a reduction of adenoma size <50% on maximally tolerated doses after at least 6 months of treatment) through the measurement of prolactin levels at baseline and at 6- and 12-month follow-up.","definition_or_measurement_approach":"Prolactin level measurements at baseline, 6 and 12 months; drug resistance defined as failure to achieve normal prolactin levels and <50% reduction in adenoma size on maximally tolerated doses after ≥6 months."}

Italy

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

23-09-2024

Processing Time Days

21

Number Of Sites

1

Number Of Participants

88

Primary sponsor

Full Name

Azienda Unita Sanitaria Locale Di Bologna

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy