[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655411":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":45,"studyPopulation":45,"armGroups":58,"interventions":72,"overallOfficials":86,"centralContacts":91,"locations":45,"responsibleParty":97,"collaborators":99,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":45,"enrollmentInfo":112,"targetDuration":45,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":130,"whyStopped":45,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":45},{"fullName":5,"class":6},"University College, London","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"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","From randomisation until normalisation (occurring within 2 years after completion of treatment).",[14,18,22,26,29,33,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Radiological treatment response","Data from MRI scans assessed for rates of stability, regression, and. progression. Overall response rate will be presented.","From baseline until 24 months after completion of treatment.",{"measure":19,"description":20,"timeFrame":21},"Radiological progression-free survival (PFS)","Progression-free survival (progression determined from an MRI scan).","From randomisation until progression (up to 2 years after completion of treatment) or death.",{"measure":23,"description":24,"timeFrame":25},"Medical therapies for hormone excess","The number and proportion of participants requiring new\u002Fchanges to medical therapy for hormone excess at each visit.","From randomisation to completion of trial participation (2 years after completion of treatment)",{"measure":27,"description":28,"timeFrame":25},"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.",{"measure":30,"description":31,"timeFrame":32},"Safety and toxicity","Adverse events, assessed by CTCAE criteria v6.0.","Between randomisation and 6 months after completion of treatment for early toxicities, and until 2 years after completion of treatment for late toxicities.",{"measure":34,"description":35,"timeFrame":36},"Quality of life (CushingQoL\u002FAcroQoL)","Quality of life (QoL) using either the CushingQoL\u002FAcroQoL (as applicable depending on participant's condition) questionnaire.","From baseline until 24 months post completion of treatment.",{"measure":38,"description":39,"timeFrame":36},"Quality of Life (EQ-5D-5L)","Quality of Life (QoL) using results of participant-reported EQ-5D-5L questionnaires.",{"measure":41,"description":42,"timeFrame":17},"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.",{"measure":44,"description":45,"timeFrame":46},"Neurocognitive function and Neuro-ophthalmology outcomes",null,"From randomisation until 24 months after completion of treatment",[48],{"measure":49,"description":50,"timeFrame":51},"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.","From 6 months prior to baseline until 2 years after completion of trial treatment.",{"allocation":53,"interventionModel":54,"interventionModelDescription":45,"primaryPurpose":55,"observationalModel":45,"timePerspective":45,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":45,"whoMasked":45},"NONE",[59,66],{"label":60,"type":61,"description":62,"interventionNames":63},"Standard dose radiotherapy","ACTIVE_COMPARATOR","Standard dose: 1.8Gy per fraction over 28 fractions.\n\n* Participants aged 18-29 who are currently eligible for PBT via standard NHS indications will receive standard dose Proton Beam Therapy (PBT).\n* Participants aged 30 and over will receive standard dose Intensity-Modulated Radiation Therapy (IMRT).",[64,65],"Radiation: Standard dose Intensity-Modulated Radiation Therapy (IMRT)","Radiation: Standard dose Proton Beam Therapy (PBT)",{"label":67,"type":68,"description":69,"interventionNames":70},"Escalated dose proton beam therapy","EXPERIMENTAL","Escalated dose: 2Gy per fraction over 28 fractions.\n\n\\- Participants will receive escalated dose Proton Beam Therapy (PBT).",[71],"Radiation: Escalated dose Proton Beam Therapy (PBT)",[73,78,82],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":45},"RADIATION","Standard dose Intensity-Modulated Radiation Therapy (IMRT)","Standard dose IMRT (1.8Gy per fraction)",[60],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":45},"Standard dose Proton Beam Therapy (PBT)","Standard dose PBT (1.8Gy per fraction)",[60],{"type":74,"name":83,"description":84,"armGroupLabels":85,"otherNames":45},"Escalated dose Proton Beam Therapy (PBT)","Escalated dose PBT (2Gy per fraction)",[67],[87],{"name":88,"affiliation":89,"role":90},"Michael Kosmin","UCLH NHS Trust","PRINCIPAL_INVESTIGATOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":45,"email":96},"PRESTO Trial Manager","CONTACT","+44 (0)20 7679 9860","ctc.presto@ucl.ac.uk",{"type":98,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[100],{"name":101,"class":102},"National Institute for Health and Care Research","UNKNOWN","100655411","phase-3-presto-a-phase-iii-randomised-controlled-trial-of-dose-escalated-proton-beam-therapy-versus-standard-of-care-radiotherapy-for-functioning-pituitary-tumours-100655411",false,"NCT07813351","PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours","PRESTO","Inclusion Criteria:\n\n1. Neuropathological confirmation of growth hormone (acromegaly) or ACTH (Cushing's disease) secreting pituitary adenoma after neurosurgical intervention.\n2. Ongoing hormonal hypersecretion as defined by local and age-specific normal range values without hormone supressing medication (may need washout).\n3. Multidisciplinary team meeting recommendation for fractionated radiotherapy.\n4. Karnofsky performance status ≥70.\n5. Age ≥18 years.\n6. Agreement to travel to a proton beam therapy centre (i.e. UCLH or The Christie) as required.\n7. Written informed consent.\n8. Agreement to be followed up at a local PRESTO trial site.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breast feeding.\n2. Prior cranial or head and neck radiotherapy treatment, including Stereotactic radiosurgery (SRS).\n3. Unsuitability or intolerability of MRI scans.\n4. Severe active comorbidities that limit compliance with trial requirements.\n5. Prior invasive malignancy unless disease free interval of ≥3 years.\n6. Unable to travel to the PBT centres as per trial requirements.","ALL","18 Years",{"count":113,"type":114},82,"ESTIMATED","INTERVENTIONAL",[117],"PHASE3","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.\n\nFollowing 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.",[120,121,122],"Acromegaly Due to Pituitary Adenoma","Cushing's Disease","Pituitary Adenoma",[124,125,126,127,128,129],"Pituitary","Acromegaly","Cushing's","Radiotherapy","Proton Beam","Adenoma","NOT_YET_RECRUITING","2026-09-28",{"date":133,"type":134},"2026-10-01","ACTUAL",{"date":136,"type":114},"2026-09",{"date":138,"type":114},"2032-09",{"name":5,"class":6}]