The PRolaCT studies - a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma.

ABSTRACT:

Background

First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal remission rates are approximately 34%. Therefore, many patients require prolonged DA treatment, while side effects negatively impact health-related quality of life (HRQoL). Endoscopic transsphenoidal resection is reserved for patients with severe side effects, or with DA-resistant prolactinoma. Surgery has a good safety profile and high probability of remission and may thus deserve a more prominent place in prolactinoma treatment. The hypothesis for this study is that early or upfront surgical resection is superior to DA treatment both in terms of HRQoL and remission rate in patients with a no

SUBMITTER: Zandbergen IM 

PROVIDER: S-EPMC8465768 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature