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Status:

RECRUITING

PRolaCT - Three Prolactinoma RCTs

Lead Sponsor:

Leiden University Medical Center

Conditions:

Prolactinoma

Prolactin-Producing Pituitary Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 yea...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 21 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

880 Patients enrolled

Trial Details

Trial ID

NCT04107480

Start Date

June 21 2019

End Date

March 31 2026

Last Update

July 20 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Amsterdam University Medical Center, loc. AMC

Amsterdam-Zuidoost, North Holland, Netherlands, 1105 AZ

2

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands, 2625 AD

3

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333 ZA