Trial Title:
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
NCT ID:
NCT05613023
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT
Description:
Stereotactic Body Radiotherapy
Arm group label:
P-SBRT
Arm group label:
PPN-SBRT
Other name:
SABR
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.
Detailed description:
This study will look at the safety of curative radiotherapy to the prostate and lymph
glands given in 5 visits, in men with high risk localised prostate cancer.
The purpose of the research is to test an advanced type of external beam radiotherapy
called stereotactic body radiotherapy (also known as SBRT) in 1128 participants with high
risk localised prostate cancer (that is, prostate cancer that has not spread beyond the
prostate gland but is at high risk of growing quickly or spreading). Importantly, this
treatment delivers a potentially curative dose of radiotherapy in only 5 treatments over
two weeks. Half the participants in the trial will receive radiotherapy to the prostate,
the other half will have radiotherapy to the prostate as well as the surrounding lymph
nodes. The investigators will follow patients in the trial for at least three and half
years to see which treatment is best. The investigators will be looking at whether it is
safe to give this treatment by reviewing any side-effects that occur and also assessing
whether giving SBRT to the lymph nodes as well as the prostate reduces the chance of
prostate cancer returning.
The treatment will take place at NHS radiotherapy centres that are experienced in giving
SBRT and radiotherapy to the pelvic nodes, and have been quality assured to deliver these
treatments
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre
Address:
City:
Cork
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Paul Kelly
Facility:
Name:
St Lukes Radiation Oncology Network
Address:
City:
Dublin
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Brian O'Neill
Facility:
Name:
Mid Western Radiation Oncology Centre
Address:
City:
Limerick
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Mazen El Bassiouni
Facility:
Name:
Auckland Hospital
Address:
City:
Auckland
Country:
New Zealand
Status:
Not yet recruiting
Contact:
Last name:
Jerusha Padayachee
Facility:
Name:
James Cook University Hospital
Address:
City:
Middlesbrough
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Darren Leaning
Facility:
Name:
Worcestershire Acute Hospitals Nhs Trust
Address:
City:
Worcester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Bartlomiej Kurec
Facility:
Name:
Belfast City Hospital
Address:
City:
Belfast
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Suneil Jain
Facility:
Name:
Bristol Haematology and Oncology Centre
Address:
City:
Bristol
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Thomas Bird
Facility:
Name:
West Suffolk NHS Foundation Trust
Address:
City:
Bury Saint Edmunds
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Alex Martin
Facility:
Name:
Addenbrookes Hospital
Address:
City:
Cambridge
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Kamalram Thippu Jayaprakash
Facility:
Name:
Velindre Cancer Centre
Address:
City:
Cardiff
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Louise Harris
Facility:
Name:
Gloucestershire Hospitals NHS Foundation Trust
Address:
City:
Cheltenham
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Joanna Bowen
Facility:
Name:
University Hospitals Coventry & Warwickshire NHS Trust
Address:
City:
Coventry
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Andrew Chan
Facility:
Name:
University Hospitals of Derby & Burton NHS Foundation Trust
Address:
City:
Derby
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Prantik Das
Facility:
Name:
North Middlesex University Hospital NHS Trust
Address:
City:
Edmonton
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Nishi Gupta
Facility:
Name:
Royal Devon & Exeter
Address:
City:
Exeter
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Mohini Varughese
Facility:
Name:
Royal Surrey County Hospital NHS Foundation Trust
Address:
City:
Guildford
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sheel Mehta
Facility:
Name:
Mount Vernon Cancer Centre
Address:
City:
Hillingdon
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Peter Ostler
Facility:
Name:
East Suffolk & North Essex NHS Foundation Trust
Address:
City:
Ipswich
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ramachandran Venkitaraman
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
King's Lynn
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Kamalram Thippu Jayaprakash
Facility:
Name:
Leeds Teaching Hospitals NHS Trust
Address:
City:
Leeds
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ann Henry
Facility:
Name:
University Hospitals of Leicester NHS Trust
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Kiran Kancherla
Facility:
Name:
United Linconshire Hospitals NHS Trust
Address:
City:
Lincoln
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Miguel Panades
Facility:
Name:
Guy's and St Thomas' Hospital NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Gurdip Kaur Azad
Facility:
Name:
Royal Free Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sarah Needleman
Facility:
Name:
St Bartholomew's Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Paula Wells
Facility:
Name:
Maidstone and Tunbridge Wells NHS Trust
Address:
City:
Maidstone
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Patryk Brullinski
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Yee Pei Song
Facility:
Name:
Freeman Hospital
Address:
City:
Newcastle upon Tyne
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Rachel Pearson
Facility:
Name:
Northampton General Hospital NHS Trust
Address:
City:
Northampton
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Jenny Branagan
Facility:
Name:
Norfolk & Norwich University Hospitals NHS Foundation Trust
Address:
City:
Norwich
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
David Maskell
Facility:
Name:
Nottingham University Hospital NHS Trust
Address:
City:
Nottingham
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Eliot Chadwick
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Philip Camilleri
Facility:
Name:
University Hospitals Plymouth NHS Trust
Address:
City:
Plymouth
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Dominique Parslow
Facility:
Name:
Portsmouth Hospitals University NHS Trust
Address:
City:
Portsmouth
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Maja Uherek
Facility:
Name:
Sheffield Teaching Hospitals NHS Foundation Trust
Address:
City:
Sheffield
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Omar Dinn
Facility:
Name:
Mid and South Essex NHS Foundation Trust
Address:
City:
Southend
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Abby Cyriac
Facility:
Name:
University Hospital North Midlands NHS Trust
Address:
City:
Stoke-on-Trent
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Salil Vengalil
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Angela Pathmanathan
Facility:
Name:
Torbay and South Devon NHS Foundation Trust
Address:
City:
Torquay
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sayeuri Buddu
Facility:
Name:
Royal Cornwall Hospital
Address:
City:
Truro
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
John McGrane
Facility:
Name:
Clatterbridge Cancer Centre
Address:
City:
Wirral
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Shaun Tolan
Start date:
September 9, 2022
Completion date:
June 2030
Lead sponsor:
Agency:
Institute of Cancer Research, United Kingdom
Agency class:
Other
Collaborator:
Agency:
Prostate Cancer UK
Agency class:
Other
Source:
Institute of Cancer Research, United Kingdom
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613023
