Actively Recruiting
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
Led by Institute of Cancer Research, United Kingdom · Updated on 2024-09-19
1128
Participants Needed
42
Research Sites
403 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
P
Prostate Cancer UK
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at randomisation
- Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months of randomisation
- Planned androgen deprivation therapy for 12 to 36 months
- High risk localised prostate cancer defined by Gleason 8-10 (grade groups 4 and 5), or Stage T3a/b or T4, or PSA > 20ng/ml (or >10 ng/ml if on 5-alpha reductase inhibitors)
- Multi-parametric MRI of the pelvis including at least one functional MRI sequence within twelve months of randomisation
- Radiological staging excluding metastatic disease prior to starting ADT using PSMA PET-CT, fluciclovine/choline PET-CT, whole-body MRI, bone scan, or CT of chest, abdomen and pelvis
- WHO performance status of 0 to 2
- Ability to give written informed consent
You will not qualify if you...
- N1 or M1 disease
- PSA >50ng/ml (or >25ng/ml if on 5-alpha reductase inhibitors) unless PET-CT confirms N0M0 disease
- Previous active treatment for prostate cancer
- Contraindications to SBRT such as prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms, or bowel close to target volumes
- Contraindications to fiducial marker insertion including clotting disorders or high risk when stopping anticoagulation or antiplatelet medications
- Bilateral hip prostheses or implants causing substantial CT artefacts affecting pelvic node planning
- Chemotherapy within 6 weeks before start of radiotherapy
- Life expectancy less than 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre
Cork, Ireland
Actively Recruiting
2
St Lukes Radiation Oncology Network
Dublin, Ireland
Actively Recruiting
3
Mid Western Radiation Oncology Centre
Limerick, Ireland
Actively Recruiting
4
Auckland Hospital
Auckland, New Zealand
Not Yet Recruiting
5
James Cook University Hospital
Middlesbrough, South Tees, United Kingdom
Actively Recruiting
6
Worcestershire Acute Hospitals Nhs Trust
Worcester, Worcestershire, United Kingdom
Actively Recruiting
7
Belfast City Hospital
Belfast, United Kingdom
Actively Recruiting
8
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Actively Recruiting
9
West Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom
Actively Recruiting
10
Addenbrookes Hospital
Cambridge, United Kingdom
Actively Recruiting
11
Velindre Cancer Centre
Cardiff, United Kingdom
Not Yet Recruiting
12
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, United Kingdom
Actively Recruiting
13
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
Actively Recruiting
14
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, United Kingdom
Actively Recruiting
15
North Middlesex University Hospital NHS Trust
Edmonton, United Kingdom
Actively Recruiting
16
Royal Devon & Exeter
Exeter, United Kingdom
Actively Recruiting
17
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Actively Recruiting
18
Mount Vernon Cancer Centre
Hillingdon, United Kingdom
Actively Recruiting
19
East Suffolk & North Essex NHS Foundation Trust
Ipswich, United Kingdom
Actively Recruiting
20
Queen Elizabeth Hospital
Kings Lynn, United Kingdom
Actively Recruiting
21
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Actively Recruiting
22
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
23
United Linconshire Hospitals NHS Trust
Lincoln, United Kingdom
Actively Recruiting
24
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
25
Royal Free Hospital
London, United Kingdom
Actively Recruiting
26
St Bartholomew's Hospital
London, United Kingdom
Not Yet Recruiting
27
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Actively Recruiting
28
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
29
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Actively Recruiting
30
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Actively Recruiting
31
Northampton General Hospital NHS Trust
Northampton, United Kingdom
Actively Recruiting
32
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Actively Recruiting
33
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
Actively Recruiting
34
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
35
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Actively Recruiting
36
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
Actively Recruiting
37
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Not Yet Recruiting
38
Mid and South Essex NHS Foundation Trust
Southend, United Kingdom
Actively Recruiting
39
University Hospital North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
Actively Recruiting
40
Royal Marsden Hospital
Sutton, United Kingdom
Actively Recruiting
41
Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom
Actively Recruiting
42
Royal Cornwall Hospital
Truro, United Kingdom
Actively Recruiting
Research Team
P
PACE-NODES Trial Manager
CONTACT
P
PACE-NODES CTPM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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