Investigating treatments for prolactinoma
PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials
This study is testing if a new surgery for prolactinoma works better than standard treatment after using medication for a while, to see how it affects patients' lives and health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 880 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 3 sites (Amsterdam-Zuidoost, Noord-Holland and 2 other locations) |
| Trial ID | NCT04107480 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endoscopic trans-sphenoidal prolactinoma resection as a first-line treatment compared to standard care, after a short or long period of pretreatment with dopamine agonists. It aims to assess various outcomes including quality of life, remission rates, biochemical disease control, and recurrence rates. The study will also analyze tumor shrinkage on MRI, pituitary function, adverse reactions, disease burden, and cost-effectiveness. Participants will be randomized into three groups based on their treatment history and characteristics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of prolactinoma and hyperprolactinaemia, who have a suitable pituitary mass for resection.
Not a fit: Patients with alternative explanations for hyperprolactinaemia or those whose pituitary mass is not amenable to resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with prolactinoma, potentially improving their quality of life and remission rates.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches for prolactinoma, but this specific comparison of treatment strategies is novel.
Eligibility criteria
Show full 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.
Where this trial is running
Amsterdam-Zuidoost, Noord-Holland and 2 other locations
- Amsterdam University Medical Center, loc. AMC — Amsterdam-Zuidoost, Noord-Holland, Netherlands (Not_yet_recruiting)
- Reinier de Graaf Gasthuis — Delft, Zuid-Holland, Netherlands (Not_yet_recruiting)
- Leiden University Medical Center — Leiden, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nienke R Biermasz, MD, prof. — Endocrinologist LUMC
- Study coordinator: Ingrid M Zandbergen, MD
- Email: i.m.zandbergen@lumc.nl
- Phone: +3171-5296748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.