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Prostate CancerPhase 3PACE-NODESNCT05613023

A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

A Phase 3 study testing SBRT in people with Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 42 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,128 participants
Where
42 sitesin 3 countries
Study dates
9 Sep 2022to Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

42 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

PACE-NODES Trial Manager contact

02087224000

pace-nodes-icrctsu@icr.ac.uk

PACE-NODES CTPM contact

02087224000

pace-nodes-icrctsu@icr.ac.uk

42 sites in 3 countries

United Kingdom38 sites, 38 recruiting

  • Belfast City Hospital

    Belfast

    Suneil Jain

    Recruiting

  • Bristol Haematology and Oncology Centre

    Bristol

    Thomas Bird

    Recruiting

  • West Suffolk NHS Foundation Trust

    Bury St Edmunds

    Alex Martin

    Recruiting

  • Addenbrookes Hospital

    Cambridge

    Kamalram Thippu Jayaprakash

    Recruiting

  • Velindre Cancer Centre

    Cardiff

    Louise Harris

    Not yet recruiting

  • Gloucestershire Hospitals NHS Foundation Trust

    Cheltenham

    Joanna Bowen

    Recruiting

  • University Hospitals Coventry & Warwickshire NHS Trust

    Coventry

    Andrew Chan

    Recruiting

  • University Hospitals of Derby & Burton NHS Foundation Trust

    Derby

    Prantik Das

    Recruiting

  • North Middlesex University Hospital NHS Trust

    Edmonton

    Nishi Gupta

    Recruiting

  • Royal Devon & Exeter

    Exeter

    Mohini Varughese

    Recruiting

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford

    Sheel Mehta

    Recruiting

  • Mount Vernon Cancer Centre

    Hillingdon

    Peter Ostler

    Recruiting

  • East Suffolk & North Essex NHS Foundation Trust

    Ipswich

    Ramachandran Venkitaraman

    Recruiting

  • Queen Elizabeth Hospital

    Kings Lynn

    Kamalram Thippu Jayaprakash

    Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds

    Ann Henry

    Recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW

    Kiran Kancherla

    Recruiting

  • United Linconshire Hospitals NHS Trust

    Lincoln

    Miguel Panades

    Recruiting

  • Guy's and St Thomas' Hospital NHS Foundation Trust

    London

    Gurdip Kaur Azad

    Recruiting

  • Royal Free Hospital

    London

    Sarah Needleman

    Recruiting

  • St Bartholomew's Hospital

    London

    Paula Wells

    Not yet recruiting

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone

    Patryk Brullinski

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester

    Yee Pei Song

    Recruiting

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

    Shaun Tolan

    Recruiting

  • James Cook University Hospital

    Middlesbrough, South Tees

    Darren Leaning

    Recruiting

  • Freeman Hospital

    Newcastle upon Tyne

    Rachel Pearson

    Recruiting

  • Northampton General Hospital NHS Trust

    Northampton

    Jenny Branagan

    Recruiting

  • Norfolk & Norwich University Hospitals NHS Foundation Trust

    Norwich

    David Maskell

    Recruiting

  • Nottingham University Hospital NHS Trust

    Nottingham

    Eliot Chadwick

    Recruiting

  • Churchill Hospital

    Oxford

    Philip Camilleri

    Recruiting

  • University Hospitals Plymouth NHS Trust

    Plymouth

    Dominique Parslow

    Recruiting

  • Portsmouth Hospitals University NHS Trust

    Portsmouth

    Maja Uherek

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield

    Omar Dinn

    Not yet recruiting

  • Mid and South Essex NHS Foundation Trust

    Southend

    Abby Cyriac

    Recruiting

  • University Hospital North Midlands NHS Trust

    Stoke-on-Trent

    Salil Vengalil

    Recruiting

  • Royal Marsden Hospital

    Sutton

    Angela Pathmanathan

    Recruiting

  • Torbay and South Devon NHS Foundation Trust

    Torquay

    Sayeuri Buddu

    Recruiting

  • Royal Cornwall Hospital

    Truro

    John McGrane

    Recruiting

  • Worcestershire Acute Hospitals Nhs Trust

    Worcester, Worcestershire

    Bartlomiej Kurec

    Recruiting

Other trials in United Kingdom

Ireland3 sites, 3 recruiting

  • Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre

    Cork

    Paul Kelly

    Recruiting

  • St Lukes Radiation Oncology Network

    Dublin

    Brian O'Neill

    Recruiting

  • Mid Western Radiation Oncology Centre

    Limerick

    Mazen El Bassiouni

    Recruiting

Other trials in Ireland

New Zealand1 site, 1 recruiting

  • Auckland Hospital

    Auckland

    Jerusha Padayachee

    Not yet recruiting

Other trials in New Zealand

About this study

Official title: PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

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.

Read the 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

Conditions
Prostate Cancer
Being tested
SBRT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    Also called SABR

    Stereotactic Body Radiotherapy

Study groups in NCT05613023
Study groupRoleWhat they receive
P-SBRTActive comparatorParticipants allocated P-SBRT will receive 36.25Gy in 5 fractions to the prostate and seminal vesicles on alternate days (40Gy to prostate CTV).
Receives: Radiation: SBRT
PPN-SBRTExperimentalParticipants 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.
Receives: Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: minimum of 3.5 years follow up post-randomisation

Secondary outcomes (7)

  1. Clinical reported acute toxicity

    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

    Measured: 12 weeks post-randomisation

  2. Clinical reported late toxicity

    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

    Measured: up to 5 years post-randomisation

  3. Metastatic relapse-free survival

    Time from randomisation to distant metastases or death from prostate cancer

    Measured: up to 5 years post-randomisation

  4. Prostate cancer-specific survival

    Time from randomisation to death due to prostate cancer

    Measured: up to 5 years post-randomisation

  5. Overall survival

    Time from randomisation to death from any cause

    Measured: up to 5 years post-randomisation

  6. Patient Reported Outcome Measures

    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.

    Measured: up to 5 years post-randomisation

  7. Adherence to radiotherapy protocol

    Qualitative analysis of adherence to pre-specified radiotherapy dose constraints with radiotherapy quality assurance to demonstrate feasibility in a muliticentre setting.

    Measured: after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start9 Sep 2022
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05613023
Sponsor's protocol ID
CCR5545
Other IDs
Prostate Cancer UK
Acronym
PACE-NODES
Status last verified
Sep 2024
First submitted
7 Mar 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pathmanathan A, Jain S, Staffurth J, Brown S, Burnett S, Cafferty FH, Choudhury A, Dewan M, Hoskin P, McBride K, McGarry CK, Miles E, Murray J, Murthy V, Naismith O, Song YP, Syndikus I, Tree A, Ward T, Hall E, van As N. PACE-NODES: A phase III randomised trial of 5 fraction prostate stereotactic body radiotherapy (SBRT) versus 5 fraction prostate and pelvic nodal SBRT. Clin Transl Radiat Oncol. 2026 Feb 11;58:101126. doi: 10.1016/j.ctro.2026.101126. eCollection 2026 May.

    PubMed 41732215

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SBRT in people with Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 42 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United Kingdom, Ireland, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact PACE-NODES Trial Manager (02087224000, pace-nodes-icrctsu@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to biochemical or clinical failure (time frame: minimum of 3.5 years follow up post-randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05613023, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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