The PROMISE Survey

Not yet recruiting

• Conditions: Prolactinoma; Pituitary Tumor

• Registration Number: NCT06936813
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Prolactinoma patients
• Prolactinoma treating physicians including endocrinologists and neurosurgeons

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Generate hypotheses for future research	6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland