The PROMISE Survey

NCT ID: NCT06936813

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 530 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2026-03-30

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.

Conditions

Prolactinoma; Pituitary Tumor

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Prolactinoma patients
• Prolactinoma treating physicians including endocrinologists and neurosurgeons

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cihan Atila

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2025-00327; kt25Atila2

Identifier Type: -

Identifier Source: org_study_id