PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours (PRESTO)
7. september 2026 opdateret af: University College, London
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
82
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: PRESTO Trial Manager
- Telefonnummer: +44 (0)20 7679 9860
- E-mail: ctc.presto@ucl.ac.uk
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Neuropathological confirmation of growth hormone (acromegaly) or ACTH (Cushing's disease) secreting pituitary adenoma after neurosurgical intervention.
- Ongoing hormonal hypersecretion as defined by local and age-specific normal range values without hormone supressing medication (may need washout).
- Multidisciplinary team meeting recommendation for fractionated radiotherapy.
- Karnofsky performance status ≥70.
- Age ≥18 years.
- Agreement to travel to a proton beam therapy centre (i.e. UCLH or The Christie) as required.
- Written informed consent.
- Agreement to be followed up at a local PRESTO trial site.
Exclusion Criteria:
- Women who are pregnant or breast feeding.
- Prior cranial or head and neck radiotherapy treatment, including Stereotactic radiosurgery (SRS).
- Unsuitability or intolerability of MRI scans.
- Severe active comorbidities that limit compliance with trial requirements.
- Prior invasive malignancy unless disease free interval of ≥3 years.
- Unable to travel to the PBT centres as per trial requirements.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard dose radiotherapy
Standard dose: 1.8Gy per fraction over 28 fractions.
|
Standard dose IMRT (1.8Gy per fraction)
Standard dose PBT (1.8Gy per fraction)
|
|
Eksperimentel: Escalated dose proton beam therapy
Escalated dose: 2Gy per fraction over 28 fractions. - Participants will receive escalated dose Proton Beam Therapy (PBT). |
Escalated dose PBT (2Gy per fraction)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to normalisation of hormone levels
Tidsramme: From randomisation until normalisation (occurring within 2 years after completion of treatment).
|
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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiological treatment response
Tidsramme: From baseline until 24 months after completion of treatment.
|
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.
|
|
Radiological progression-free survival (PFS)
Tidsramme: From randomisation until progression (up to 2 years after completion of treatment) or death.
|
Progression-free survival (progression determined from an MRI scan).
|
From randomisation until progression (up to 2 years after completion of treatment) or death.
|
|
Medical therapies for hormone excess
Tidsramme: From randomisation to completion of trial participation (2 years after completion of treatment)
|
The number and proportion of participants requiring new/changes to medical therapy for hormone excess at each visit.
|
From randomisation to completion of trial participation (2 years after completion of treatment)
|
|
Changes to hormone levels
Tidsramme: From randomisation to completion of trial participation (2 years after completion of treatment)
|
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.
|
From randomisation to completion of trial participation (2 years after completion of treatment)
|
|
Safety and toxicity
Tidsramme: Between randomisation and 6 months after completion of treatment for early toxicities, and until 2 years after completion of treatment for late toxicities.
|
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.
|
|
Quality of life (CushingQoL/AcroQoL)
Tidsramme: From baseline until 24 months post completion of treatment.
|
Quality of life (QoL) using either the CushingQoL/AcroQoL (as applicable depending on participant's condition) questionnaire.
|
From baseline until 24 months post completion of treatment.
|
|
Quality of Life (EQ-5D-5L)
Tidsramme: From baseline until 24 months post completion of treatment.
|
Quality of Life (QoL) using results of participant-reported EQ-5D-5L questionnaires.
|
From baseline until 24 months post completion of treatment.
|
|
Pituitary insufficiency rates
Tidsramme: From baseline until 24 months after completion of treatment.
|
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.
|
From baseline until 24 months after completion of treatment.
|
|
Neurocognitive function and Neuro-ophthalmology outcomes
Tidsramme: From randomisation until 24 months after completion of treatment
|
From randomisation until 24 months after completion of treatment
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health Economic Evaluation
Tidsramme: From 6 months prior to baseline until 2 years after completion of trial treatment.
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Kosmin, UCLH NHS Trust
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2032
Studieafslutning (Anslået)
1. september 2032
Datoer for studieregistrering
Først indsendt
1. september 2026
Først indsendt, der opfyldte QC-kriterier
7. september 2026
Først opslået (Faktiske)
10. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Knoglesygdomme
- Muskuloskeletale sygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i endokrine kirtler
- Neoplasmer, kirtel og epitel
- Neoplasmer i nervesystemet
- Neoplasmer i centralnervesystemet
- Hypothalamus sygdomme
- Hypothalamiske neoplasmer
- Supratentoriale neoplasmer
- Neoplasmer i hjernen
- Hyperpituitarisme
- Knoglesygdomme, endokrine
- Adenom
- Hypofyse neoplasmer
- Hypofysesygdomme
- Hypofyse ACTH Hypersekretion
- Akromegali
- Væksthormon-udskillende hypofyseadenom
- Terapeutik
- Strålebehandling
- Strålebehandling, konform
- Strålebehandling, computerassisteret
- Tung ionstrålebehandling
- Strålebehandling, intensitetsmoduleret
- Protonterapi
Andre undersøgelses-id-numre
- UCL/181514
- NIHR168012 (Andet bevillings-/finansieringsnummer: National Institute for Health and Care Research (NIHR))
- 369251 (Anden identifikator: IRAS)
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