Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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