NCT06936813

The PROMISE Survey

Patients' and Physicians' Perspectives on the Management of Prolactinomas: Experiences, Treatment Preferences, and Related Outcomes - The PROMISE Survey

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 530 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The PROMISE Survey was developed to systematically assess the real-world experiences, treatment preferences, side effects, and outcomes from both patients and physicians dealing with prolactinomas. The aim is to generate insights that can guide future clinical research and improve individualized care strategies.

Detailed description

Background Prolactinomas are the most common hormone-producing pituitary tumors, causing symptoms like menstrual irregularities, infertility, galactorrhea, and reduced libido due to elevated prolactin levels. The standard treatment involves dopamine agonists (DAs) such as cabergoline or bromocriptine, which are usually effective. However, many patients report side effects (e.g., nausea, dizziness, psychiatric symptoms), leading to challenges in long-term adherence and uncertainty about outcomes after discontinuing therapy. Surgical treatment has emerged as a potentially safe and effective alternative, especially for selected patients, but perspectives from both patients and physicians on treatment preferences and outcomes are not well studied. The survey is designed to be completed in 5-10 minutes, fostering high participation across diverse patient and physician populations. Data are collected anonymous covers the following areas: 1. Patient Characteristics 2. DA Therapy 3. Surgical Treatment 4. Diagnostic Pathway 5. Treatment Side Effects \& Recurrence 6. Quality of Life and Psychosocial Impact 7. Physician Perspectives 8. Knowledge Gaps 9. Hypothesis Generation Outcome The collected data will inform: * Better understanding of real-world management and challenges in prolactinoma care. * Insights for improving clinical guidelines, patient education, and treatment decision-making. * Hypotheses for future studies comparing outcomes of DA therapy vs. surgery and optimizing long-term management strategies.

Conditions

• Prolactinoma
• Pituitary Tumor

Timeline

• Start date: 2025-06-13
• Primary completion: 2026-01-01
• Completion: 2026-03-30
• First posted: 2025-04-20
• Last updated: 2026-01-08

Locations

1 site across 1 country: Switzerland