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

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT06638541

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Prostate radical radiotherapy (radiation)
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
Prostate radical radiotherapy — radiation: Radiation: De-escalated radiotherapy to be delivered on the Elekta Unity MR-linac
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at prostate cancer radiotherapy given in just 2 treatment sessions, using a special machine called an MR-Linac that combines an MRI scanner with a radiotherapy machine. The aim is to see whether a lower dose can be given to the whole prostate while a higher dose targets the visible tumour. It is sponsored by the Royal Marsden NHS Foundation Trust.

Who can take part

  • Men aged 18 or over with confirmed prostate cancer that needs radiotherapy aiming to cure it
  • Cancer that is slow to medium growing (Gleason score 3+3, 3+4 or 4+3, grade groups 1, 2 or 3)
  • An MRI scan done within the last year showing the cancer has not spread beyond the prostate (stage T3a or less)
  • A tumour visible on MRI that is under 2.5cm at its widest point and confirmed as cancer by biopsy
  • PSA (a blood test for prostate cancer) below 20 ng/ml before any hormone therapy starts, if hormone therapy is used
  • Being well enough overall (World Health Organization performance status 0-2)
  • Being able and willing to give consent, use contraception during treatment and for 1 year after where it applies, and complete questionnaires during the study

Who may not be able to

  • Being unable to have an MRI scan (for example because of a pacemaker, certain metal implants, or severe claustrophobia)
  • Severe urinary symptoms, or an IPSS symptom score above 19
  • A prostate larger than 90cc
  • A hip replacement or other pelvic metalwork that badly affects MRI scans
  • Previous radiotherapy to the pelvis
  • Conditions such as inflammatory bowel disease that could raise the risk of side effects, or other health problems that would prevent long-term follow-up
  • Needing more than 6 months of hormone therapy because of the cancer
  • Another invasive cancer in the last 2 years that is likely to shorten life (with some exceptions, such as some skin cancers)
  • Taking part in another prostate cancer trial testing treatments

What taking part involves

  • • Radiotherapy to the prostate given in 2 treatment sessions on an MR-Linac machine (an MRI scanner combined with a radiotherapy machine)
  • • Hormone therapy (androgen deprivation therapy) may be given at the same time if that would be standard care, but it is not required if it would normally be left out
  • • Completing patient questionnaires throughout the study

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
54
Started
2025-01-20
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • NA - 54 participants
  • • DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • Manchester - The Christie NHS Foundation Trust
  • • Sutton - The Royal Marsden NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

54 patients meeting inclusion criteria will be randomised between two arms. Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. The primary endpoint is emergent acute GU CTCAE v5 Grade 2+ toxicity, recorded within 3 months of completing radiotherapy. Secondary endpoints are CT CAE v5 acute GI toxicity, late toxicity, patient-reported outcome measures (PROMs) (EPIC-26, IPSS, and IIEF-5) at 4 and 12 weeks, 6 months, 1 and 2 years post treatment, PSA control and kinetics

Prostate Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSAnow negative

What the study is looking for

  • ✓Men aged ≥18 years
  • ✓Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  • ✓Gleason score 3+3, 3+4 or 4+3 (Grade groups (GG) 1, 2 or 3)
  • ✓MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation
  • ✓The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed...

Who cannot take part

  • ✗Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
  • ✗Severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.
  • ✗IPSS Score \> 19
  • ✗High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider...
  • ✗Prostate volume \>90cc
See the full criteria
Inclusion Criteria: 1. Men aged ≥18 years 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy 3. Gleason score 3+3, 3+4 or 4+3 (Grade groups (GG) 1, 2 or 3) 4. MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation 5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and \<2.5cm in maximal dimension 6. The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed in inclusion factor 3) 7. Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. 8. PSA \<20 ng/ml prior to starting ADT, if used 9. WHO Performance status 0-2 10. Ability of the participant understand and the willingness to sign a written informed consent form. 11. Willing to consent to contraception during and for 1 year after treatment when applicable. 12. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study. Exclusion Criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) 2. Severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician. 3. IPSS Score \> 19 4. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (eg GG1, low volume GG2) is allowed outside of the MRI-defined area. 5. Prostate volume \>90cc 6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 7. Hip replacement, or other pelvic metalwork which causes significant artefact on diffusion-weighted imaging 8. Previous pelvic radiotherapy 9. Patients needing \>6 months of ADT due to disease parameters. 10. Previous invasive malignancy within the last 2 years where this is likely to shorten lifespan the following will remain eligible: basal or squamous carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance. 11. Participating in another interventional trial for prostate cancer

Where Is This Study? (2 UK sites)

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Francesca Mason

Sponsor contact

CONTACT

+44 20 3186 5157 mrltrials@rmh.nhs.uk

Sian Cooper

Sponsor contact

CONTACT

sian.cooper@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-07