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Can a stronger radiation dose fix hormone overload?

NCT ID NCT07813351

Disease control Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether a higher dose of proton beam therapy can normalise hormone levels better than standard radiotherapy in people with functioning pituitary tumours, including acromegaly and Cushing's disease. Participants receive about six weeks of either standard-dose radiotherapy or higher-dose proton beam therapy, then are followed for at least two years with hormone, tumour, and quality-of-life checks. The trial aims to see which approach brings growth hormone or ACTH levels back to normal more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
proton beam therapy and intensity-modulated radiation therapy
What this could lead to
If higher-dose proton therapy works better, it could become a more effective way to bring hormone levels back to normal for people with functioning pituitary tumours.
What could go wrong
The trial is small and the approach is still being tested, so it may not show a clear benefit over standard radiotherapy. Higher radiation doses also carry a risk of damaging nearby healthy tissue.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 82 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Neuropathological confirmation of growth hormone (acromegaly) or ACTH (Cushing's disease) secreting pituitary adenoma after neurosurgical intervention. 2. Ongoing hormonal hypersecretion as defined by local and age-specific normal range values without hormone supressing medication (may need washout). 3. Multidisciplinary team meeting recommendation for fractionated radiotherapy. 4. Karnofsky performance status ≥70. 5. Age ≥18 years. 6. Agreement to travel to a proton beam therapy centre (i.e. UCLH or The Christie) as required. 7. Written informed consent. 8. Agreement to be followed up at a local PRESTO trial site. Exclusion Criteria: 1. Women who are pregnant or breast feeding. 2. Prior cranial or head and neck radiotherapy treatment, including Stereotactic radiosurgery (SRS). 3. Unsuitability or intolerability of MRI scans. 4. Severe active comorbidities that limit compliance with trial requirements. 5. Prior invasive malignancy unless disease free interval of ≥3 years. 6. Unable to travel to the PBT centres as per trial requirements.

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Conditions

The condition(s) this trial relates to.

acromegaly ACTH-dependent Cushing syndrome adenoma Cushing disease due to pituitary adenoma growth hormone-producing pituitary gland adenoma Growth Hormone-Secreting Pituitary Adenoma pituitary gland adenoma pituitary gland disorder Pituitary Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acromegaly due to pituitary adenoma Cushing's disease Pituitary adenoma

How to take part

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  1. The official record

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