Microprolactinomas MedDRA version: 20.1 Level: PT Classification code 10036831 Term: Prolactin-producing pituitary tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: DOSTINEX - 0.5MG COMPRESSE 8 COMPRESSE
Pharmaceutical Form: Tablet
INN or Proposed INN: CABERGOLINA
Current Sponsor code: G02CB03
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
AZIENDA USL DI BOLOGNA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the non-inferiority of EES with respect to CAB (standard care) for the rate of biochemical remission (defined as prolactin normalization in the absence of treatment) at 6- and 12-month follow-up, in newly diagnosed, treatment naïve patients with m-PRL.;Secondary Objective: - To determine m-PRL remnant at MRI with g.c.m. performed at 6 and 12 months after EES or starting CAB. - To determine 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), and of AEs, in patients treated with CAB. Potential predictors of drug resistance may be also investigated. - To determine the type and rate of surgical complications. Potential predictors of surgical complications may be also investigated.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 6 and 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): MRI with g.c.m will be performed at study enrollment (baseline) and at 6- and 12- month follow-up to evaluate m-PRL diameter, so the ability of EES and CAB to reduce tumor mass. Patient QoL, depression and anxiety scores (DAS) and ICD-RB will be assessed at baseline and at 6- and 12-month follow-up through self-administered validated questionnaires in patients randomized to CAB. Intra- and inter-patient variations will be recorded. Descriptive analysis will be performed to determine the overall impact of CAB on QoL, as well as the type and incidence of physical and psychological AEs. Prolactin levels at baseline and at 6- and 12-month follow-up will be assessed to determine the rate of drug resistance. Predictive analysis will be then performed to identify pre-treatment patient and m-PRL factors associated with increased risk of AEs and of CAB resistance. Patient QoL and DAS will be assessed at baseline and at 6- and 12-month follow-up through self-administered validated questionnaires (same as per patients treated with CAB) in patients randomized to EES arm. Intra- and inter-patient variations will be recorded. Descriptive analysis will be performed to determine the overall impact of EES on QoL, as well as the type and incidence of surgical complications. Predictive analysis will be then performed to identify pre-treatment patient and m-PRL factors associated with increased risk of developing surgical complications.;Timepoint(s) of evaluation of this end point: 3, 6 and 12 month | — |
Countries
Italy
Contacts
Public ContactProgramma Neurochirurgia Ipofisi
Azienda USL di Bologna - IRCCS ISNB
Outcome results
None listed