Clinical trial · Interventional
PRolaCT - Three Prolactinoma RCTs
PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prolactinoma | Lactotroph Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Prolactin-Producing Pituitary Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dopamine Agonists | Drug | — | UNRESOLVED |
| Endoscopic trans-sphenoidal adenoma resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients in the intervention groups will be referred to one of the participating neurosurgical centers, for surgical consultation. After this consultation, the patient may choose to continue with surgery or not.
- interventionNames
- Procedure: Endoscopic trans-sphenoidal adenoma resection
- type
- ACTIVE_COMPARATOR
- label
- Standard care
- description
- Patients in the standard care groups will receive treatment as usual as described by the US Endocrine Society.
- interventionNames
- Drug: Dopamine Agonists
Primary outcomes (2)
- measure
- Health-Related Quality of Life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age. * A history of signs and symptoms compatible with the diagnosis prolactinoma. * New, recent (PRolaCT-1) or known diagnosis of hyperprolactinaemia, defined as a prolactin level 2 times the local laboratory maximum. At the time of randomization hyperprolactinaemia is still present, or was present \< 12 months before inclusion (PRolaCT-2 and PRolaCT-3). * No clear alternative explanation for hyperprolactinaemia, e.g. medication use. * Presence of a clearly identifiable (persisting) pituitary mass on MRI not invading the cavernous sinus and having an optimal chance to be completely resected (generally adenomas with a maximum diameter nog exceeding 25mm). A representative MRI at the time of randomization is required, this MRI should generally not be older than 12 months in PRolaCT-3 and 2 months in PRolaCT-1 and PRolaCT-2. * Competent and able to fill in questionnaires. * One of the following, dividing patients in to our three RCTs: * PRolaCT-1: no prior treatment for prolactinoma; * PRolaCT-2: treatment with a dopamine agonist for 4-6 months; or * PRolaCT-3: treatment with a dopamine agonist for at least 2 years. Exclusion Criteria: * Contraindication for one of the treatment modalities, e.g. severe side effect of cabergoline, contraindications to surgery, or a clear indication for surgical resection. * Pregnancy at the time of randomization. * Clinical acromegaly. * Prior pituitary gland surgery or radiotherapy to the pituitary gland area. * Severe renal failure (eGFR \<30 ml/min). * Insufficient understanding of the Dutch or English language. * Other medical conditions that to the opinion of the physician are not compatible with inclusion in a trial. Patients eligible for participation in one of the RCTs, but do not consent to randomisation or in whom there is a clear patient or physician preference for either DA treatment or surgery, are considered for participation in PRolaCT-O.
References
Publications (1)
- DERIVEDZandbergen IM, Zamanipoor Najafabadi AH, Pelsma ICM, van den Akker-van Marle ME, Bisschop PHLT, Boogaarts HDJ, van Bon AC, Burhani B, le Cessie S, Dekkers OM, Drent ML, Feelders RA, de Graaf JP, Hoogmoed J, Kapiteijn KK, van der Klauw MM, Nieuwlaat WCM, Pereira AM, Stades AME, van de Ven AC, Wakelkamp IMMJ, van Furth WR, Biermasz NR; Dutch Prolactinoma Study Group. The PRolaCT studies - a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma. Trials. 2021 Sep 25;22(1):653. doi: 10.1186/s13063-021-05604-y. PMID 34563236