Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06638541

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions

Led by Royal Marsden NHS Foundation Trust · Updated on 2026-03-23

54

Participants Needed

3

Research Sites

101 weeks

Total Duration

On this page

Sponsors

R

Royal Marsden NHS Foundation Trust

Lead Sponsor

E

Elekta Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also look at late toxicity, patient-reported outcome measures and PSA control.

CONDITIONS

Official Title

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 6518 years
  • Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  • Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
  • MRI stage T3a or less performed within a year of randomisation
  • MRI-visible tumour(s) of PIRADS v2 grade 3 or higher, delineable on imaging, and less than 2.5 cm in size
  • MRI-defined lesion confirmed malignant on biopsy with appropriate Gleason grade
  • Concurrent androgen deprivation therapy allowed if standard of care
  • PSA less than 20 ng/ml before starting ADT if used
  • WHO Performance status 0-2
  • Ability and willingness to provide written informed consent
  • Willingness to use contraception during and for 1 year after treatment if applicable
  • Ability and willingness to comply with patient-reported outcome questionnaires schedule
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as pacemaker, mobile metal implant, or claustrophobia
  • Severe urinary symptoms precluding extreme hypofractionation as judged by physician
  • International Prostate Symptom Score (IPSS) greater than 19
  • High grade disease outside MRI-defined lesion requiring surveillance
  • Prostate volume greater than 90 cc
  • Comorbidities causing significant toxicity risk or preventing long-term follow-up
  • Hip replacement or pelvic metal causing imaging artefact
  • Previous pelvic radiotherapy
  • Need for androgen deprivation therapy longer than 6 months due to disease
  • Previous invasive cancer within 2 years likely to shorten lifespan except certain skin or bladder cancers or small renal masses
  • Participation in another interventional prostate cancer trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Sunnybrook Health Sciences Centre

Toronto, Canada

Not Yet Recruiting

2

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Actively Recruiting

3

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Actively Recruiting

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Research Team

F

Francesca Mason

CONTACT

S

Sian Cooper

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions | DecenTrialz