Exploring the SPARAGMOS Study Protocol: review of a high-dose cabergoline interventional trial in microprolactinomas

Prolactinoma is the most common subtype of pituitary adenoma, and dopamine agonists are the gold standard for treatment, primarily cabergoline. Current guidelines suggest that transsphenoidal surgery could be offered, especially to young women with noninvasive microprolactinomas, due to its cost-effectiveness. Additionally, concerns regarding the long-term use of dopamine agonists and their lower remission rates have been raised. The SPARAGMOS trial (NCT07463235) will be an interventional, randomized, open-label, multicenter study utilizing a high dose of cabergoline for approximately 6 months to suppress prolactin levels, with the hypothetical goal of achieving greater tumor apoptosis and remission rates. Under this protocol, a remission rate of approximately 70% is hypothesized, similar to that achieved through neurosurgery in specialized pituitary centers or when cabergoline is carefully considered for withdrawal (i.e. treatment duration exceeding 2 years, low dosing, tumor shrinkage, and normoprolactinemia). The control group will receive cabergoline for 2 years at the lowest dose necessary to achieve normoprolactinemia, as per current guidelines. Under these conditions, the remission rate is expected to be low, around 30%. The findings from this trial have the potential to influence and redefine future therapeutic strategies for microprolactinoma.