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OncoMatch/Clinical Trials/NCT04107480

PRolaCT - Three Prolactinoma RCTs

Is NCT04107480 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Dopamine Agonists for prolactinoma.

Phase 4RecruitingLeiden University Medical CenterNCT04107480Data as of May 2026

Treatment: Dopamine AgonistsThis 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.

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Extracted eligibility criteria

Prior therapy

Must have received: dopamine agonist — PRolaCT-2: 4-6 months; PRolaCT-3: at least 2 years

PRolaCT-2: treatment with a dopamine agonist for 4-6 months; PRolaCT-3: treatment with a dopamine agonist for at least 2 years

Cannot have received: pituitary gland surgery

Prior pituitary gland surgery

Cannot have received: radiotherapy to the pituitary gland area

Prior...radiotherapy to the pituitary gland area

Lab requirements

Kidney function

Severe renal failure (eGFR <30 ml/min) excluded

Severe renal failure (eGFR <30 ml/min)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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