A Phase 3 interventional study of Standard dose Intensity-Modulated Radiation Therapy (IMRT) and Standard dose Proton Beam Therapy (PBT) in Acromegaly Due to Pituitary Adenoma, Cushing's Disease and Pituitary Adenoma, sponsored by University College, London. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to evaluate whether a higher dose of radiotherapy can lead to better outcomes for participants with functioning pituitary tumours. The main question it aims to answer is whether a greater proportion of participants will achieve normal hormone levels with the higher dose of proton beam radiotherapy than with standard radiotherapy treatment doses.
Following randomisation, participants will receive approximately 6 weeks of either standard dose radiotherapy (intensity-modulated radiation therapy or proton beam therapy, depending on age) OR escalated dose proton beam therapy. Following this, participants will be followed up for at least 2 years to monitor their condition. This includes pituitary, hormone level, tumour, neurocognitive, and ophthalmology assessments, as well as patient-reported quality of life outcomes and health economic measures.
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's planned enrollment of 82 is above the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard dose: 1.8Gy per fraction over 28 fractions. * Participants aged 18-29 who are currently eligible for PBT via standard NHS indications will receive standard dose Proton Beam Therapy (PBT). * Participants aged 30 and over will receive standard dose Intensity-Modulated Radiation Therapy (IMRT).
Radiation: Standard dose Intensity-Modulated Radiation Therapy (IMRT) · Radiation: Standard dose Proton Beam Therapy (PBT)
Escalated dose: 2Gy per fraction over 28 fractions. \- Participants will receive escalated dose Proton Beam Therapy (PBT).
Radiation: Escalated dose Proton Beam Therapy (PBT)
Standard dose IMRT (1.8Gy per fraction)
Standard dose PBT (1.8Gy per fraction)
Escalated dose PBT (2Gy per fraction)
Time to normalisation of hormone levels
Time to normalisation of hormone levels (i.e. growth hormone (GH) or insulin growth factor 1 (IGF-1)) following randomised treatment
Time frame: From randomisation until normalisation (occurring within 2 years after completion of treatment).
Radiological treatment response
Data from MRI scans assessed for rates of stability, regression, and. progression. Overall response rate will be presented.
Time frame: From baseline until 24 months after completion of treatment.
Radiological progression-free survival (PFS)
Progression-free survival (progression determined from an MRI scan).
Time frame: From randomisation until progression (up to 2 years after completion of treatment) or death.
Medical therapies for hormone excess
The number and proportion of participants requiring new/changes to medical therapy for hormone excess at each visit.
Time frame: From randomisation to completion of trial participation (2 years after completion of treatment)
Changes to hormone levels
Hormone levels relevant to the participant's disease (e.g. growth hormone \[GH\]) will be measured at each trial visit, summarised, and compared over time between treatment arms.
Time frame: From randomisation to completion of trial participation (2 years after completion of treatment)
Safety and toxicity
Adverse events, assessed by CTCAE criteria v6.0.
Time frame: Between randomisation and 6 months after completion of treatment for early toxicities, and until 2 years after completion of treatment for late toxicities.
Quality of life (CushingQoL/AcroQoL)
Quality of life (QoL) using either the CushingQoL/AcroQoL (as applicable depending on participant's condition) questionnaire.
Time frame: From baseline until 24 months post completion of treatment.
Quality of Life (EQ-5D-5L)
Quality of Life (QoL) using results of participant-reported EQ-5D-5L questionnaires.
Time frame: From baseline until 24 months post completion of treatment.
Pituitary insufficiency rates
Pituitary insufficiency rates (i.e. Growth hormone (GH), Adrenocorticotropic hormone (ACTH), Thyroid-Stimulating Hormone (TSH), Gonadotrophin, and Arginine Vasopressin (AVP) deficiencies) will be summarised and compared between arms.
Time frame: From baseline until 24 months after completion of treatment.
Neurocognitive function and Neuro-ophthalmology outcomes
Time frame: From randomisation until 24 months after completion of treatment
Health Economic Evaluation
The health economic analysis will calculate the mean incremental cost per quality-adjusted life-years (QALYs) gained on using dose-escalated proton beam therapy compared to standard dose radiotherapy.
Time frame: From 6 months prior to baseline until 2 years after completion of trial treatment.
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2032, 72 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pituitary ACTH Hypersecretion →