prolactin secreting pituitary adenoma Prolactinoma
Conditions
Interventions
The intervention groups of the three RCTs are referred to a participating
neurosurgical expertise center for extensive neurosurgical counseling with the
intention to perform the endoscopic trans-sph
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - At least 18 years of age. - A history of signs and symptoms compatible with the diagnosis prolactinoma. - New, recent (PRolaCT-1) or known diagnosis of hyperprolactinaemia, defined as a prolactin level 2 times the local laboratory maximum. At the time of randomization hyperprolactinaemia is still present, or was present 12 months As mentioned in Amendment 6 dated 19-01-2024, all randomized arms (PRolaCT-1,2,3) will be closed because of low willingness to randomize. All eligible patients will therefore be inclded in the observational arm (PRolaCT-O). As mentioned in Amendment 7 dated 19-11-2024, participants of all pretreatment duration groups (PRolaCT-1,2,3) will be recruited for the observational arm, resulting in a total of 3x220 participants = 660 participants.
Exclusion criteria
Exclusion criteria: - Contraindication for one of the treatment modalities, e.g. severe side effect of cabergoline, contraindications to surgery, or a clear indication for surgical resection. - Pregnancy at the time of randomization. - Clinical acromegaly. - Prior radiotherapy to the pituitary gland area. - Severe renal failure (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has two main outcomes, including the health-related quality of life after 12 months as measured on the mental health sub scale of the Short-Form 36 questionnaire; and the percentage of patients in remission after 36 months, where remission is defined as normoprolactinaemia (a prolactin below the upper limit of normal as defined by the laboratory where it is measured) in the absence of dopamine agonist treatment or an actual pregnancy that was established in the absence of dopamine agonist treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes of this study are: - Remission rate, according to the above mentioned definition, 27 and 60 months after randomization. - Biochemical disease control, defined as normoprolactinaemia (a prolactin below the upper limit of normal as defined by the laboratory where it is measured), or an actual pregnancy, with or without dopamine agonist treatment, measured 12 months after randomisation. - Disease recurrence, 36 and 60 months after randomisation, defined as recurrence of hyperprolactinaemia in the absence of dopamine agonist treatment in patients who achieved disease remission at T=27. - Clinical symptom control 12, 27, 36 and 60 months after randomization, defined as: > the absence of psychiatric symptoms measured with the Hospital Anxiety and Depression Scale; and > the absence of physical symptoms that are associated with prolactinoma, i.e. galactorrhea, hypogonadism, loss of libido, subfertility, emotional complaints, headache and visual complaints. - Tumor shrinkage after 12 and 36 months, defined as a reduction in maximal diameter or tumor volume of at least 20% on pituitary MRI. - Normal(ized) pituitary functioning 12, 36 and 60 months after randomisation, defined as normal funtioning of the following pituitary axes: > gonadal axis, assessed with measurement of FSH, LH and estrogen or testosterone > thyroidal axis, assessed with measurement of TSH and free T4 > corticoid axis, assessed with measurement of morning cortisol and if suppressed an additional CRH- or synacthen-test > growth hormone axis, assessed with measurement of IGF-1 and additional GH-suppression test or insulin-tolerance test, when indicated > ADH secretion, assessed with measurement of serum sodium - The occurrence of adverse reactions to treatment after 12 and 36 months, defined as the occurrence of side effects to dopamine agonist treatment documented with the use of the National Cancer Institute Patient-Reported Outcomes version of the Co | — |
Countries
Netherlands
Outcome results
None listed