PRolaCT - Three Prolactinoma RCTs

  • STATUS
    Recruiting
  • End date
    Mar 31, 2026
  • participants needed
    880
  • sponsor
    Leiden University Medical Center
Updated on 24 January 2021

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.

Details
Condition Prolactinoma, Prolactin-Producing Pituitary Tumor, Prolactin-Producing Pituitary Tumor, prolactinomas, Prolactin-Producing Pituitary Tumor
Treatment Endoscopic trans-sphenoidal adenoma resection, Dopamine Agonists, Dopamine Agonists
Clinical Study IdentifierNCT04107480
SponsorLeiden University Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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