PRolaCT - Three Prolactinoma RCTs

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04107480
• Date of registration: 27/08/2019
• Prospective Registration: No
• Primary sponsor: Leiden University Medical Center
• Public title: PRolaCT - Three Prolactinoma RCTs
• Scientific title: PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials
• Date of first enrolment: June 21, 2019
• Target sample size: 880
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04107480
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Netherlands

Contacts

• Name: Ingrid M Zandbergen, MD

• Name: Nienke R Biermasz, MD, prof.
• Affiliation: Endocrinologist LUMC

• Name: Wouter R van Furth, MD, PhD
• Affiliation: Neurosurgeon LUMC

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Prolactin-Producing Pituitary Tumor

Prolactinoma

Intervention(s)

Drug: Dopamine Agonists

Procedure: Endoscopic trans-sphenoidal adenoma resection

Primary Outcome(s)

Long-term remission [Time Frame: 36 months after randomization/baseline]

Health-Related Quality of Life [Time Frame: 12 months after randomization/baseline]

Secondary Outcome(s)

Complications [Time Frame: Baseline and 12 months after randomization/baseline]

Depression and anxiety scores [Time Frame: baseline and 12 and 36 months after randomization/baseline]

Disease burden [Time Frame: baseline and 12, 36 and 60 months after randomization/baseline]

Recurrence rate [Time Frame: 36 and 60 months after randomization/baseline]

Side effects [Time Frame: Baseline and 12, 27 and 36 months after randomization/baseline]

Healthcare costs [Time Frame: Every 6 months until 36 months after randomization/baseline]

Very long-term remission [Time Frame: 60 months after randomization/baseline]

Short-term remission [Time Frame: 27 months after randomization/baseline]

Pituitary functioning [Time Frame: 12 and 36 months after randomization/baseline]

Tumor shrinkage on MRI [Time Frame: 12 and 36 months after randomization/baseline]

Clinical symptom control [Time Frame: 12, 27, 36 and 60 months after randomization/baseline]

Health-Related Quality of Life [Time Frame: Baseline and 12, 27, 36 and 60 months after randomization/baseline]

Biochemical disease control [Time Frame: 12 months after randomization/baseline]

Non-healthcare costs [Time Frame: Every 6 months until 36 months after randomization/baseline]

Quality-Adjusted Life Years (QALYs) [Time Frame: Baseline and 6, 9, 12, 18, 24, 27, 30 and 36 months after randomization/baseline]

Secondary ID(s)

843002806

NL63919.058.18

PRolaCT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors