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
- SBRT (radiation)
- How long the study runs
- Study runs about 93 months (dates as stated)
- About the drug or intervention
- SBRT — radiation: Stereotactic Body Radiotherapy
- Patient visit burden
- "This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer." (as stated by sponsor)
In plain English
This UK trial is for men with high-risk localised prostate cancer. It compares two types of targeted radiotherapy (SBRT, short for stereotactic body radiotherapy) given in 5 sessions: one aimed only at the prostate, and one aimed at the prostate plus the pelvic lymph nodes. The trial is sponsored by the Institute of Cancer Research.
Who can take part
- Men aged 18 or over
- Prostate cancer confirmed by a tissue test (biopsy) with a Gleason/ISUP grade, done within the last 12 months
- High-risk cancer that has not spread, defined by one or more of: Gleason score 8-10 (grade group 4 or 5), stage T3a/b or T4, or PSA above 20 ng/ml (above 10 ng/ml if taking 5-alpha reductase inhibitor medicine)
- Planned to have 12-36 months of hormone therapy (androgen deprivation therapy)
- A special MRI scan of the pelvis done within the last 12 months
- Scans showing the cancer has not spread (for example PET-CT, whole-body MRI, bone scan or CT scan)
- Fairly well and able to carry out light activity (WHO performance status 0-2)
- Able to give written informed consent
Who may not be able to
- Cancer that has spread to the lymph nodes (N1) or other parts of the body (M1)
- PSA above 50 ng/ml (above 25 ng/ml on 5-alpha reductase inhibitors), unless a PET-CT scan confirms no spread
- Previous active treatment for prostate cancer
- Reasons why SBRT is unsafe, such as previous pelvic radiotherapy, inflammatory bowel disease, or significant urinary symptoms
- Bowel lying too close to the treatment area for pelvic radiotherapy to be given safely
- Problems having fiducial marker insertion (small markers placed to guide radiotherapy), such as clotting disorders or high risk from stopping blood-thinning medicines
- Hip replacements on both sides, or other implants that would interfere with treatment planning scans
- Chemotherapy within 6 weeks before radiotherapy starts
- Life expectancy under 5 years
What taking part involves
- • Radiotherapy (SBRT) given in 5 treatment sessions
- • One group receives radiotherapy to the prostate only; the other group receives radiotherapy to the prostate and the pelvic lymph nodes
- • Hormone therapy (androgen deprivation therapy) for 12-36 months
- • Further details of what taking part involves: Not stated — ask the trial team
Time commitment: Radiotherapy is given in 5 sessions alongside 12-36 months of hormone therapy; other details about hospital visits and follow-up are not stated — ask the trial team.
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
- 1,128
- Started
- 2022-09-09
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase3 - 1,128 participants
- • This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Middlesbrough - James Cook University Hospital
- • Worcester - Worcestershire Acute Hospitals Nhs Trust
- • Belfast - Belfast City Hospital
- • Bristol - Bristol Haematology and Oncology Centre
- • +34 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.
More detail
This study will look at the safety of curative radiotherapy to the prostate and lymph glands given in 5 visits, in men with high risk localised prostate cancer. The purpose of the research is to test an advanced type of external beam radiotherapy called stereotactic body radiotherapy (also known as SBRT) in 1128 participants with high risk localised prostate cancer (that is, prostate cancer that has not spread beyond the prostate gland but is at high risk of growing quickly or spreading). Importantly, this treatment delivers a potentially curative dose of radiotherapy in only 5 treatments over two weeks. Half the participants in the trial will receive radiotherapy to the prostate, the other half will have radiotherapy to the prostate as well as the surrounding lymph nodes. The investigators will follow patients in the trial for at least three and half years to see which treatment is best. The investigators will be looking at whether it is safe to give this treatment by reviewing any side-effects that occur and also assessing whether giving SBRT to the lymph nodes as well as the prostate reduces the chance of prostate cancer returning. The treatment will take place at NHS radiotherapy centres that are experienced in giving SBRT and radiotherapy to the pelvic nodes, and have been quality assured to deliver these treatments
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
- ✓Aged ≥ 18 years at randomisation
- ✓Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months...
- ✓Patients planned for 12-36 months androgen deprivation therapy
- ✓High risk localised prostate cancer as defined by
- ✓Gleason 8-10 (grade groups 4 and 5) and/or
Who cannot take part
- ✗N1 or M1 disease
- ✗PSA \>50ng/ml (or \>25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed...
- ✗Previous active treatment for prostate cancer
- ✗Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk...
- ✗Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make...
See the full criteria
Where Is This Study? (38 UK sites)
James Cook University Hospital
Middlesbrough, United Kingdom
Worcestershire Acute Hospitals Nhs Trust
Worcester, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, United Kingdom
North Middlesex University Hospital NHS Trust
Edmonton, United Kingdom
Royal Devon & Exeter
Exeter, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Mount Vernon Cancer Centre
Hillingdon, United Kingdom
East Suffolk & North Essex NHS Foundation Trust
Ipswich, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351United Linconshire Hospitals NHS Trust
Lincoln, United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Royal Free Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Denise Day / Julie Knowles
mtw-tr.researchgovernance@nhs.net01622 225627The Christie NHS Foundation Trust
Manchester, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Northampton General Hospital NHS Trust
Northampton, United Kingdom
Michelle Spinks, Head of Research
ngh-tr.research.unit@nhs.net01604 545941Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Mid and South Essex NHS Foundation Trust
Southend, United Kingdom
University Hospital North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
How to Get in Touch
PACE-NODES Trial Manager
Sponsor contactCONTACT
PACE-NODES CTPM
Sponsor contactCONTACT