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Clinical Trials in Ireland / NCT05613023
Recruiting Phase 3

A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

NCT05613023 · tracked via the Priya Life Science Ireland tracker
Sponsor
Institute of Cancer Research, United Kingdom
Phase
Phase 3
Started
2022-09-09
Last updated
2024-09-19

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SBRT

SBRT: Stereotactic Body Radiotherapy

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Aged ≥ 18 years at randomisation 2. 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) 3. Patients planned for 12-36 months androgen deprivation therapy 4. 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) 5. Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisation 6. 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). 7. WHO performance status 0-2 8. Ability of research subject to give written informed consent Exclusion Criteria: 1. N1 or M1 disease 2. PSA \>50ng/ml (or \>25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease 3. Previous active treatment for prostate cancer 4. 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. 5. Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications 6. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult. 7. Patients who have had chemotherapy within 6 weeks of the start of radiotherapy. 8. Life expectancy \< 5 years

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre Cork Ireland Recruiting
St Lukes Radiation Oncology Network Dublin Ireland Recruiting
Mid Western Radiation Oncology Centre Limerick Ireland Recruiting
Auckland Hospital Auckland New Zealand Not Yet Recruiting
James Cook University Hospital Middlesbrough South Tees Recruiting
Worcestershire Acute Hospitals Nhs Trust Worcester Worcestershire Recruiting
Belfast City Hospital Belfast United Kingdom Recruiting
Bristol Haematology and Oncology Centre Bristol United Kingdom Recruiting
West Suffolk NHS Foundation Trust Bury St Edmunds United Kingdom Recruiting
Addenbrookes Hospital Cambridge United Kingdom Recruiting
Velindre Cancer Centre Cardiff United Kingdom Not Yet Recruiting
Gloucestershire Hospitals NHS Foundation Trust Cheltenham United Kingdom Recruiting
University Hospitals Coventry & Warwickshire NHS Trust Coventry United Kingdom Recruiting
University Hospitals of Derby & Burton NHS Foundation Trust Derby United Kingdom Recruiting
North Middlesex University Hospital NHS Trust Edmonton United Kingdom Recruiting
Royal Devon & Exeter Exeter United Kingdom Recruiting
Royal Surrey County Hospital NHS Foundation Trust Guildford United Kingdom Recruiting
Mount Vernon Cancer Centre Hillingdon United Kingdom Recruiting
East Suffolk & North Essex NHS Foundation Trust Ipswich United Kingdom Recruiting
Queen Elizabeth Hospital Kings Lynn United Kingdom Recruiting
Leeds Teaching Hospitals NHS Trust Leeds United Kingdom Recruiting
University Hospitals of Leicester NHS Trust Leicester United Kingdom Recruiting
United Linconshire Hospitals NHS Trust Lincoln United Kingdom Recruiting
Guy's and St Thomas' Hospital NHS Foundation Trust London United Kingdom Recruiting
Royal Free Hospital London United Kingdom Recruiting
St Bartholomew's Hospital London United Kingdom Not Yet Recruiting
Maidstone and Tunbridge Wells NHS Trust Maidstone United Kingdom Recruiting
The Christie NHS Foundation Trust Manchester United Kingdom Recruiting
Clatterbridge Cancer Centre Metropolitan Borough of Wirral United Kingdom Recruiting
Freeman Hospital Newcastle upon Tyne United Kingdom Recruiting
Northampton General Hospital NHS Trust Northampton United Kingdom Recruiting
Norfolk & Norwich University Hospitals NHS Foundation Trust Norwich United Kingdom Recruiting
Nottingham University Hospital NHS Trust Nottingham United Kingdom Recruiting
Churchill Hospital Oxford United Kingdom Recruiting
University Hospitals Plymouth NHS Trust Plymouth United Kingdom Recruiting
Portsmouth Hospitals University NHS Trust Portsmouth United Kingdom Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom Not Yet Recruiting
Mid and South Essex NHS Foundation Trust Southend United Kingdom Recruiting
University Hospital North Midlands NHS Trust Stoke-on-Trent United Kingdom Recruiting
Royal Marsden Hospital Sutton United Kingdom Recruiting

+ 2 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05613023 on ClinicalTrials.gov ↗ ← All trials in Ireland