A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
Recruiting · NCT05613023 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Cancer Research, United Kingdom
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Aged ≥ 18 years at randomisation
- Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months of randomisation (unless otherwise discussed with the CI or co-Clinical Leads)
- 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
- Stage T3a/b or T4 and/or
- PSA \> 20ng/ml (or \>10 ng/ml for patients on 5-alpha reductase inhibitors)
- Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisation
- Radiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine/choline PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice/standard of care).
- WHO performance status 0-2
- Ability of research subject to give written informed consent
Exclusion criteria
- N1 or M1 disease
- PSA \>50ng/ml (or \>25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease
- Previous active treatment for prostate cancer
- Patients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded.
- Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.
- Patients who have had chemotherapy within 6 weeks of the start of radiotherapy.
- Life expectancy \< 5 years
Where it is running
42 locations listed.
- Auckland Hospital - Auckland, New Zealand
- 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
- Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre - Cork, Ireland
- University Hospitals Coventry & Warwickshire NHS Trust - Coventry, United Kingdom
- University Hospitals of Derby & Burton NHS Foundation Trust - Derby, United Kingdom
- St Lukes Radiation Oncology Network - Dublin, Ireland
- 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, United Kingdom
- Mid Western Radiation Oncology Centre - Limerick, Ireland
- United 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
- The 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
- Norfolk & 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
- James Cook University Hospital - Middlesbrough, South Tees, United Kingdom
- Worcestershire Acute Hospitals Nhs Trust - Worcester, Worcestershire, United Kingdom