Spots Global Cancer Trial Database for PRolaCT - Three Prolactinoma RCTs
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Trial Identification
Brief Title: PRolaCT - Three Prolactinoma RCTs
Official Title: PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials
Study ID: NCT04107480
Study Description
Brief Summary: This 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Amsterdam University Medical Center, loc. AMC, Amsterdam-Zuidoost, Noord-Holland, Netherlands
Reinier de Graaf Gasthuis, Delft, Zuid-Holland, Netherlands
Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands
Contact Details
Name: Nienke R Biermasz, MD, prof.
Affiliation: Endocrinologist LUMC
Role: PRINCIPAL_INVESTIGATOR
Name: Wouter R van Furth, MD, PhD
Affiliation: Neurosurgeon LUMC
Role: PRINCIPAL_INVESTIGATOR
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