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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05613023
Registration number
NCT05613023
Ethics application status
Date submitted
7/03/2022
Date registered
14/11/2022
Date last updated
19/09/2024
Titles & IDs
Public title
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
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Scientific title
PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
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Secondary ID [1]
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Prostate Cancer UK
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Secondary ID [2]
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CCR5545
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Universal Trial Number (UTN)
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Trial acronym
PACE-NODES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - SBRT
Active comparator: P-SBRT - Participants allocated P-SBRT will receive 36.25Gy in 5 fractions to the prostate and seminal vesicles on alternate days (40Gy to prostate CTV).
Experimental: PPN-SBRT - Participants 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.
Treatment: Other: SBRT
Stereotactic Body Radiotherapy
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to biochemical or clinical failure
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Assessment method [1]
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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).
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Timepoint [1]
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minimum of 3.5 years follow up post-randomisation
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Secondary outcome [1]
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Clinical reported acute toxicity
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Assessment method [1]
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Clinical reported acute and late toxicity using CTCAE version 5.0 and RTOG criteria. Focus will be given to GU and GI Grade 2 or higher (G2+) toxicities
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Timepoint [1]
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12 weeks post-randomisation
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Secondary outcome [2]
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Clinical reported late toxicity
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Assessment method [2]
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Clinical reported acute and late toxicity using CTCAE version 5.0 and RTOG criteria. Focus will be given to GU and GI Grade 2 or higher (G2+) toxicities
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Timepoint [2]
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up to 5 years post-randomisation
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Secondary outcome [3]
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Metastatic relapse-free survival
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Assessment method [3]
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Time from randomisation to distant metastases or death from prostate cancer
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Timepoint [3]
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up to 5 years post-randomisation
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Secondary outcome [4]
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Prostate cancer-specific survival
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Assessment method [4]
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Time from randomisation to death due to prostate cancer
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Timepoint [4]
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up to 5 years post-randomisation
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Secondary outcome [5]
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Overall survival
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Assessment method [5]
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Time from randomisation to death from any cause
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Timepoint [5]
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up to 5 years post-randomisation
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Secondary outcome [6]
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Patient Reported Outcome Measures
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Assessment method [6]
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Quality of life will be evaluated using combined data from the following questionnaires. IPSS questionnaire: a validated diagnostic tool used to assess urinary \& bowel incontinence. IIEF-5: validated diagnostic tool for erectile dysfunction. EPIC questionnaire: to assess typical symptoms after radiotherapy in prostate cancer patients. EQ-5D: a commonly used generic questionnaire to measure health-related QoL used to asess mobility, self-care, usual activities, pain/discomfort, anxiety/depression \& the subject's perceptions of their own current overall health. A QoL analysis plan will be developed in consultation with the TMG with key endpoints for each questionnaire. Standard algorithms will be used to derive scores and handle missing data. Changes from baseline at each time point will be compared within groups as well as between treatment groups (by means of ordinal logistic regressions or ANCOVA models). Analyses to account for the longitudinal nature of the data may be used.
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Timepoint [6]
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up to 5 years post-randomisation
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Secondary outcome [7]
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Adherence to radiotherapy protocol
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Assessment method [7]
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Qualitative analysis of adherence to pre-specified radiotherapy dose constraints with radiotherapy quality assurance to demonstrate feasibility in a muliticentre setting.
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Timepoint [7]
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after completion of treatment
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2030
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Actual
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Sample size
Target
1128
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment outside Australia
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Ireland
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Cork
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Ireland
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Dublin
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Ireland
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Limerick
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New Zealand
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Auckland
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United Kingdom
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South Tees
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Worcestershire
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Belfast
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Bristol
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Bury Saint Edmunds
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Cambridge
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Cardiff
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Cheltenham
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Coventry
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Derby
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Edmonton
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Exeter
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Guildford
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Hillingdon
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Ipswich
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King's Lynn
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Leeds
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Leicester
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Lincoln
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London
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Maidstone
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Manchester
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Newcastle upon Tyne
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Northampton
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Nottingham
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Oxford
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Plymouth
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Portsmouth
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Sheffield
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Southend
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Sutton
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Torquay
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Truro
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Wirral
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Funding & Sponsors
Primary sponsor type
Other
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Name
Institute of Cancer Research, United Kingdom
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Prostate Cancer UK
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05613023
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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PACE-NODES Trial Manager
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Phone
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02087224000
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05613023
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