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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
Scientific title
PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
Secondary ID [1] 0 0
Prostate Cancer UK
Secondary ID [2] 0 0
CCR5545
Universal Trial Number (UTN)
Trial acronym
PACE-NODES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to biochemical or clinical failure
Timepoint [1] 0 0
minimum of 3.5 years follow up post-randomisation
Secondary outcome [1] 0 0
Clinical reported acute toxicity
Timepoint [1] 0 0
12 weeks post-randomisation
Secondary outcome [2] 0 0
Clinical reported late toxicity
Timepoint [2] 0 0
up to 5 years post-randomisation
Secondary outcome [3] 0 0
Metastatic relapse-free survival
Timepoint [3] 0 0
up to 5 years post-randomisation
Secondary outcome [4] 0 0
Prostate cancer-specific survival
Timepoint [4] 0 0
up to 5 years post-randomisation
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
up to 5 years post-randomisation
Secondary outcome [6] 0 0
Patient Reported Outcome Measures
Timepoint [6] 0 0
up to 5 years post-randomisation
Secondary outcome [7] 0 0
Adherence to radiotherapy protocol
Timepoint [7] 0 0
after completion of treatment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2030
Actual
Sample size
Target
1128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Ireland
State/province [1] 0 0
Cork
Country [2] 0 0
Ireland
State/province [2] 0 0
Dublin
Country [3] 0 0
Ireland
State/province [3] 0 0
Limerick
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
United Kingdom
State/province [5] 0 0
South Tees
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Worcestershire
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Belfast
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Bristol
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Bury Saint Edmunds
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Cambridge
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cardiff
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Cheltenham
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Coventry
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Derby
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Edmonton
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Exeter
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Guildford
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Hillingdon
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Ipswich
Country [20] 0 0
United Kingdom
State/province [20] 0 0
King's Lynn
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Leeds
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Leicester
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Lincoln
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Maidstone
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Newcastle upon Tyne
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Northampton
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Norwich
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Nottingham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Oxford
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Plymouth
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Portsmouth
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Sheffield
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Southend
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Stoke-on-Trent
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Sutton
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Torquay
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Truro
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Other
Name
Institute of Cancer Research, United Kingdom
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Prostate Cancer UK
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05613023
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
PACE-NODES Trial Manager
Address 0 0
Country 0 0
Phone 0 0
02087224000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05613023