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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (2 UK sites)
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
How to Get in Touch
Francesca Mason
Sponsor contactCONTACT
Sian Cooper
Sponsor contactCONTACT
