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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

82

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard dose radiotherapy

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).
Straling: Standard dose Intensity-Modulated Radiation Therapy (IMRT)
Standard dose IMRT (1.8Gy per fraction)
Straling: Standard dose Proton Beam Therapy (PBT)
Standard dose PBT (1.8Gy per fraction)
Experimenteel: Escalated dose proton beam therapy

Escalated dose: 2Gy per fraction over 28 fractions.

- Participants will receive escalated dose Proton Beam Therapy (PBT).
Straling: Escalated dose Proton Beam Therapy (PBT)
Escalated dose PBT (2Gy per fraction)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to normalisation of hormone levels
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radiological treatment response
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From randomisation until 24 months after completion of treatment
From randomisation until 24 months after completion of treatment

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health Economic Evaluation
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University College, London

Medewerkers

National Institute for Health and Care Research

Onderzoekers

  • Hoofdonderzoeker: Michael Kosmin, UCLH NHS Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2032

Studie voltooiing (Geschat)

1 september 2032

Studieregistratiedata

Eerst ingediend

1 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2026

Eerst geplaatst (Werkelijk)

10 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

7 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UCL/181514
  • NIHR168012 (Ander subsidie-/financieringsnummer: National Institute for Health and Care Research (NIHR))
  • 369251 (Andere identificatie: IRAS)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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