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OpenTrials
Active, Not Recruiting

NCT Number: NCT06936813

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prolactinoma Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Pituitary Tumor Supratentorial Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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:

  • Patient Characteristics
  • DA Therapy
  • Surgical Treatment
  • Diagnostic Pathway
  • Treatment Side Effects & Recurrence
  • Quality of Life and Psychosocial Impact
  • Physician Perspectives
  • Knowledge Gaps
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prolactinoma patients
  • Prolactinoma treating physicians including endocrinologists and neurosurgeons

Treatment and study plan

Primary outcomes

  1. Generate hypotheses for future research

    Time frame: 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 outcomes

  1. Collect data on patient characteristics

    Time frame: 6 months

    Distribution of patient demographics, cause of prolactinoma, additional pituitary disfunctions, symptom burden before diagnosis

  2. Assess patient experiences with dopamine agonist (DA) therapy

    Time frame: 6 months

    Distribution of DA types and dosing, side effects, remission

  3. Evaluate patient experiences with surgical treatment

    Time frame: 6 months

    Percentage of patients who underwent surgery, rate of complications, remission, additional treatment

  4. Collect data on diagnostic pathways

    Time frame: 6 months

    Proportion of patients who underwent MRI or biochemical testing, number of consultations before diagnosis

  5. Evaluate patient-reported quality of life (QoL) and psychosocial impact

    Time frame: 6 months

    Quality of life (QoL) and employment or lifestyle limitations due to symptoms or medication side effects, psychological comorbidities

  6. Assess physician perspectives on treatment strategies

    Time frame: 6 months

    Distribution of first-line treatment preferences, criteria used for surgical referral, long-term monitoring, management strategies of endocrinologists and neurosurgeons

  7. Investigate patient and physician knowledge gaps

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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