The PROMISE Survey

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pituitary Tumor; Prolactinoma

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.

• Study Type: Observational
• Enrollment (Actual): 530

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Prolactinoma patients and physicians involved in the management of prolactinomas. Survey will be accessible globally via online patient communities, pituitary disorder organizations, physician networks, and in-clinic distribution.

Description

Inclusion Criteria:

• Prolactinoma patients
• Prolactinoma treating physicians including endocrinologists and neurosurgeons

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generate hypotheses for future research	Generate real-world patient-centered data to identify patterns in treatment outcomes, patient-reported challenges, and areas where additional clinical trials are needed to develop new hypothesis for future research	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect data on patient characteristics	Distribution of patient demographics, cause of prolactinoma, additional pituitary disfunctions, symptom burden before diagnosis	6 months
Assess patient experiences with dopamine agonist (DA) therapy	Distribution of DA types and dosing, side effects, remission	6 months
Evaluate patient experiences with surgical treatment	Percentage of patients who underwent surgery, rate of complications, remission, additional treatment	6 months
Collect data on diagnostic pathways	Proportion of patients who underwent MRI or biochemical testing, number of consultations before diagnosis	6 months
Evaluate patient-reported quality of life (QoL) and psychosocial impact	Quality of life (QoL) and employment or lifestyle limitations due to symptoms or medication side effects, psychological comorbidities	6 months
Assess physician perspectives on treatment strategies	Distribution of first-line treatment preferences, criteria used for surgical referral, long-term monitoring, management strategies of endocrinologists and neurosurgeons	6 months
Investigate patient and physician knowledge gaps	Awareness of alternative treatment options, concerns about recurrence risk after therapy discontinuation, fertility and pregnancy management, patient satisfaction with treatment-related education and counseling	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Cihan Atila, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Survey
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Pituitary Diseases; Pituitary Neoplasms; Prolactinoma
• Other Study ID Numbers: 2025-00327; kt25Atila2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No