ArticleTrials2021
The PRolaCT studies - a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04107480 (PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials), which is not on this map. Cited by 14 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials
Who cites it
14 citing papers in PubMed, 17 citations in OpenAlex.
- Endoscopic surgery for noninvasive prolactinomas: A large multicenter, single-arm, retrospective study (PRLomaSaR).Endocrine · 2026Article
- Subtle Cognitive Impairments and Psychological Complaints in Patients With Prolactinoma Despite Biochemical Control.The Journal of clinical endocrinology and metabolism · 2025Article
- Endoscopic endonasal transcavernous surgery for a contemporary series of 59 prolactinomas.Pituitary · 2025Article
- The Changing Treatment Paradigm for Prolactinoma-A Prospective Series of 100 Consecutive Neurosurgical Cases.The Journal of clinical endocrinology and metabolism · 2025Article
- Predictors of favorable long-term outcomes in first-line surgery for microprolactinomas.Journal of neuro-oncology · 2025Article
- Gender differences in prolactin thresholds and their association with lactotroph adenoma invasiveness for potential treatment considerations.Scientific reports · 2025Article
- Reframing the Paradigm: A Nuanced Approach to Prolactinoma Management.Endocrinology and metabolism (Seoul, Korea) · 2024Article
- Tumour fibrosis in dopamine agonist-exposed prolactinomas is a diminishing concern.Nature reviews. Endocrinology · 2024Article
- The Value of ER∝ in the Prognosis of GH- and PRL-Secreting PitNETs: Clinicopathological Correlations.International journal of molecular sciences · 2023Article
- Care trajectories of surgically treated patients with a prolactinoma: why did they opt for surgery?Pituitary · 2023Observational
- Patient-reported outcomes in refractory hormone-producing pituitary adenomas: an unmet need.Pituitary · 2023Review
- Surgical Management of Giant Prolactinomas: A Descriptive Study.International journal of endocrinology · 2023Article
- Dopamine agonist therapy for prolactinomas: do we need to rethink the place of surgery in prolactinoma management?Endocrine oncology (Bristol, England) · 2022Review
- Machine Learning for Outcome Prediction in First-Line Surgery of Prolactinomas.Frontiers in endocrinology · 2022Article
Corrections and comments
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Authors and funding
24 authors at 9 institutions in 2 countries.
Funding
Abstract
backgroundFirst-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 non-invasive prolactinoma of limited size.
methodsWe present a combined randomised clinical trial and observational cohort study design, which comprises three unblinded randomised controlled trials (RCTs; PRolaCT-1, PRolaCT-2, PRolaCT-3), and an observational study arm (PRolaCT-O) that compare neurosurgical counselling, and potential subsequent endoscopic transsphenoidal adenoma resection, with current standard care. Patients with a non-invasive prolactinoma (< 25 mm) will be eligible for one of three RCTs based on the duration of pre-treatment with DAs: PRolaCT-1: newly diagnosed, treatment-naïve patients; PRolaCT-2: patients with limited duration of DA treatment (4-6 months); and PRolaCT-3: patients with persisting prolactinoma after DA treatment for > 2 years. PRolaCT-O will include patients who decline randomisation, due to e.g. a clear treatment preference. Primary outcomes are disease remission after 36 months and HRQoL after 12 months. DISCUSSION: Early or upfront surgical resection for patients with a limited-sized prolactinoma may be a reasonable alternative to the current standard practice of DA treatment, which we will investigate in three RCTs and an observational cohort study. Within the three RCTs, patients will be randomised between neurosurgical counselling and standard care. The observational study arm will recruit patients who refuse randomisation and have a pronounced treatment preference. PRolaCT will collect randomised and observational data, which may facilitate a more individually tailored practice of evidence-based medicine.
trial registrationUS National Library of Medicine registry (ClinicalTrials.gov) NCT04107480 . Registered on 27 September 2019, registered retrospectively (by 2 months).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.