ProlactinomaNCT06936813
The PROMISE Survey
An observational study of Prolactinoma and Pituitary Tumor, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolactinoma, Pituitary Tumor
- How many people
- 530 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jun 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Prolactinoma patients
- Prolactinoma treating physicians including endocrinologists and neurosurgeons
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Prolactinoma, Pituitary Tumor
- Keywords
- Survey
- Medical subject headings
- Prolactinoma, Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (7)
Collect data on patient characteristics
Distribution of patient demographics, cause of prolactinoma, additional pituitary disfunctions, symptom burden before diagnosis
Measured: 6 months
Assess patient experiences with dopamine agonist (DA) therapy
Distribution of DA types and dosing, side effects, remission
Measured: 6 months
Evaluate patient experiences with surgical treatment
Percentage of patients who underwent surgery, rate of complications, remission, additional treatment
Measured: 6 months
Collect data on diagnostic pathways
Proportion of patients who underwent MRI or biochemical testing, number of consultations before diagnosis
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start13 Jun 2025
- Primary completion1 Jan 2026
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cihan Atila, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936813
- Sponsor's protocol ID
- 2025-00327; kt25Atila2
- Other IDs
- 2025
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' and Physicians' Perspectives on the Management of Prolactinomas: Experiences, Treatment Preferences, and Related Outcomes - The PROMISE Survey
- ClinicalTrials.gov ID
- NCT06936813
- Acronym / sponsor ID
- 2025-00327; kt25Atila2
- Conditions
- Prolactinoma, Pituitary Tumor
- Keywords
- Survey
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Prolactinoma patients
- Prolactinoma treating physicians including endocrinologists and neurosurgeons
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Collect data on patient characteristics
Time frame: 6 months
Assess patient experiences with dopamine agonist (DA) therapy
Time frame: 6 months
Evaluate patient experiences with surgical treatment
Time frame: 6 months
Collect data on diagnostic pathways
Time frame: 6 months
Evaluate patient-reported quality of life (QoL) and psychosocial impact
Time frame: 6 months
Assess physician perspectives on treatment strategies
Time frame: 6 months
Investigate patient and physician knowledge gaps
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Prolactinoma
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Active, not recruitingObservational study
Long Term Outcome Study in Patients With Pituitary Disorders
Pituitary Diseases, Pituitary Neoplasms
RecruitingPhase 3
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
RecruitingPhase 2
A Study of Pasireotide in People With Prolactinoma
Prolactin-Producing Pituitary Tumor
RecruitingPhase 4
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Prolactinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cihan Atila principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolactinoma and Pituitary Tumor, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generate hypotheses for future research (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.