RecruitingPhase 3NCT05613023

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

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

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

1,128 participants

Start Date

Sep 9, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two radiation therapy approaches for men with high-risk localized prostate cancer: treating just the prostate in 5 sessions (SBRT), versus treating both the prostate and the nearby pelvic lymph nodes in 5 sessions. Both groups also receive hormone therapy (androgen deprivation therapy). **You may be eligible if...** - You are 18 years or older - You have histologically confirmed prostate cancer - Your cancer is high-risk (Gleason 8–10, or T3a/T3b/T4 stage, or PSA above 20 ng/mL) - You are planned for 12–36 months of hormone therapy (androgen deprivation therapy) - You have had a multi-parametric MRI of the pelvis **You may NOT be eligible if...** - Your cancer is low- or intermediate-risk - You have not had a qualifying MRI or biopsy within the required timeframe - You have other conditions that make radiation therapy unsafe (check full criteria with your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT

Stereotactic Body Radiotherapy

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

View Full Details on ClinicalTrials.gov

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NCT05613023

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