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RECRUITING

NCT05613023

PHASE3

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

Sponsor: Institute of Cancer Research, United Kingdom

View on ClinicalTrials.gov

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.

Official title: PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1128

Start Date

2022-09-09

Completion Date

2030-06

Last Updated

2024-09-19

Healthy Volunteers

Conditions

Prostate Cancer

Interventions

RADIATION

SBRT

Stereotactic Body Radiotherapy

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

Locations (42)

Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre

Cork, Ireland

St Lukes Radiation Oncology Network

Dublin, Ireland

Mid Western Radiation Oncology Centre

Limerick, Ireland

Auckland Hospital

Auckland, New Zealand

James Cook University Hospital

Middlesbrough, South Tees, United Kingdom

Worcestershire Acute Hospitals Nhs Trust

Worcester, Worcestershire, 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

University 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, United Kingdom

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (42)