PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials

Trial ID: NCT04107480

Interventional - Phase 4 - Unknown status

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

• Prolactinoma
• Prolactin-Producing Pituitary Tumor

Interventions

• Endoscopic trans-sphenoidal adenoma resection
• Dopamine Agonists

Eligibility

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.

Sponsor

Leiden University Medical Center

Source: ClinicalTrials.gov

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