A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
PACE-NODES
PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
2 other identifiers
interventional
1,128
3 countries
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Sep 2022
Typical duration for phase_3 prostate-cancer
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedStudy Start
First participant enrolled
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
September 19, 2024
September 1, 2024
5.7 years
March 7, 2022
September 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Time to biochemical or clinical failure
Time to biochemical or clinical failure as defined by time from randomisation to the first progression event (either biochemical failure, local recurrence, lymph node/pelvic recurrence, distant metastases, recommencement of androgen deprivation therapy or death due to prostate cancer).
minimum of 3.5 years follow up post-randomisation
Secondary Outcomes (7)
Clinical reported acute toxicity
12 weeks post-randomisation
Clinical reported late toxicity
up to 5 years post-randomisation
Metastatic relapse-free survival
up to 5 years post-randomisation
Prostate cancer-specific survival
up to 5 years post-randomisation
Overall survival
up to 5 years post-randomisation
- +2 more secondary outcomes
Study Arms (2)
P-SBRT
ACTIVE COMPARATORParticipants allocated P-SBRT will receive 36.25Gy in 5 fractions to the prostate and seminal vesicles on alternate days (40Gy to prostate CTV).
PPN-SBRT
EXPERIMENTALParticipants allocated PPN-SBRT will receive 36.25Gy in 5 fractions to the prostate and seminal vesicles on alternate days (40Gy to prostate clinical target volume (CTV)) and 25Gy in 5 fractions to pelvic nodes on alternate days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Cancer Research, United Kingdomlead
- Prostate Cancer UKcollaborator
Study Sites (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, LE1 5WW, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2022
First Posted
November 14, 2022
Study Start
September 9, 2022
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
September 19, 2024
Record last verified: 2024-09