Clinical Trials

NCT IdNCT04107480
TitlePRolaCT - Three Prolactinoma RCTs
ConditionProlactinoma
StudyTypeInterventional
OrganizationLeiden University Medical Center
Sponsor/CollaboratorsLeiden University Medical Center
StatusRecruiting
GenderAll
AgeGroupAdult
Older Adult
Location (with distance)
  • Amsterdam University Medical Center, loc. AMC, Amsterdam-Zuidoost, 1105 AZ , Netherlands
  • Reinier de Graaf Gasthuis, Delft, 2625 AD , Netherlands
  • Leiden University Medical Center, Leiden, 2333 ZA , Netherlands
DescriptionThis study aims to investigate if endoscopic trans-sphenoidal prolactinoma resection as a first line treatment, or as an equally valid second line treatment after a short (4-6 months) or long (>2 years) period of pretreatment with a dopamine agonist is superior to standard care for several outcome parameters. The main objectives are to investigate this for quality of life and remission rate. The secondary objectives are to investigate this for biochemical disease control, recurrence rates, clinical symptom control, tumor shrinkage on MRI, pituitary functioning, the occurrence of adverse reactions to treatment, disease burden, and cost-effectiveness.