PRolaCT - Three Prolactinoma RCTs

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Pituitary Neoplasms
Prolactin-Producing Pituitary Tumor
Prolactinoma

Clinical Trial Details

NCT number	NCT04107480
Study type	Interventional
Source	Leiden University Medical Center
Contact	Ingrid M Zandbergen, MD
Phone	+3171-5296748
Email	i.m.zandbergen@lumc.nl
Status	Recruiting
Phase	Phase 4
Start date	June 21, 2019
Completion date	March 31, 2026

View Details

See also
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Not yet recruiting	`NCT03400865` - Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas	N/A
Completed	`NCT00481299` - Insulin Resistance in Women With Prolactinoma	N/A
Terminated	`NCT04106531` - Validation of a Quality of Life Metric "Prolac-10"
Completed	`NCT01504399` - Rhinological Outcomes in Endonasal Pituitary Surgery
Recruiting	`NCT03474601` - Seoul National University Pituitary Disease Cohort Study
Completed	`NCT00697814` - Clomiphene in Males With Prolactinomas and Persistent Hypogonadism	Phase 2
Completed	`NCT05236829` - Exercise Capacity and Physical Activity Level in Prolactinoma Patients
Recruiting	`NCT03353025` - Study on Therapy of Non-invasive Prolactinoma	N/A
Recruiting	`NCT03457389` - Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma	N/A
Recruiting	`NCT01775332` - Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools	N/A
Not yet recruiting	`NCT03717454` - Dopamine D2 Receptors(D2R) Imaging in Prolactinomas	N/A
Recruiting	`NCT00001595` - An Investigation of Pituitary Tumors and Related Hypothalmic Disorders