Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
2205 participants
INTERVENTIONAL
2012-08-07
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PACE-A: Prostatectomy vs prostate SBRT
Low and intermediate risk patients, for whom surgery is considered, will be randomised to prostatectomy vs prostate SBRT delivered with 36.25 Gy in 5 fractions.
Prostatectomy
Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
PACE-B: Conventionally Fractionated RT vs Prostate SBRT
Low and intermediate risk patients, for whom surgery is not considered or who refuse surgery, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 78 Gy in 39 fractions or 62 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.
Conventionally Fractionated Prostate Radiotherapy
Conventional fractionation delivered to a dose of:
(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions
Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
PACE-C: Conventionally Fractionated RT vs Prostate SBRT
Intermediate and high risk patients, indicated for 6 months ADT, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 60 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.
Conventionally Fractionated Prostate Radiotherapy
Conventional fractionation delivered to a dose of:
(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions
Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Interventions
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Prostatectomy
Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
Conventionally Fractionated Prostate Radiotherapy
Conventional fractionation delivered to a dose of:
(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions
Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Eligibility Criteria
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Inclusion Criteria
* Men aged ≥18 years at randomisation
* WHO performance status 0 - 2
* Patients considered candidates for surgery are eligible for PACE-A; patients not considered candidates for surgery and patients who decline surgery or prefer to avoid surgery are eligible for PACE-B and PACE-C.
* Ability of the research subject to understand and the willingness to sign a written informed consent document.
* Minimum of 10 biopsy cores.
* Gleason score ≤ 3+4
* Clinical and/or MRI stage T1c -T2c, N0-X, M0-X
* PSA ≤ 20 ng/ml (completed within 60 days of randomisation)
* Patients belonging to one of the following risk groups:
* Low risk - patients with tumours meeting all of the following criteria:
* Gleason ≤ 6
* Clinical stage T1-T2a
* PSA \< 10 ng/ml (within 60 days prior to randomisation)
* Intermediate risk - patients with tumours meeting any one of the following criteria:
* Gleason 3+4
* Clinical stage T2b or T2c
* PSA 10-20 ng/ml (within 60 days prior to randomisation)
* Patient planned for a minimum of 6 months ADT (maximum of 12 months). Patients receiving extended androgen deprivation therapy (18 months maximum) to permit safe delay of radiotherapy as a result of the COVID19 pandemic (only) are eligible.
* Gleason score ≤ 4+4
* MRI stage T1c -T3a, N0-X, M0-X
* PSA ≤ 30 ng/ml (within 60 days prior to starting ADT)
* Patients belonging to one of the following risk groups:
* Intermediate risk - includes the presence of any of the following, assuming no high risk features apply:
* Gleason 7 (3+4 or 4+3)
* T2 (N0, M0-X)
* PSA 10-20 ng/ml
* High risk - patients with tumours that meet a maximum of 2 of the following criteria:
* Gleason 4+4 (max ≤ 50% cores)
* T3a (N0, M0)
* PSA \>20 ng/ml
Exclusion Criteria
* Prior pelvic radiotherapy.
* Prior androgen deprivation therapy (including androgen agonists and antagonists) for PACE-A and PACE-B participants.
* Any prior active treatment for prostate cancer (with the exception of ADT for PACE-C participants). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
* Life expectancy \<5 years.
* Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts.
* Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms.
* For patients having fiducials inserted: Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician.
* Participation in another concurrent treatment protocol for prostate cancer.
* \>14 weeks of androgen deprivation therapy prior to randomisation
* Medical conditions likely to make ADT inadvisable (e.g. significant and ongoing cardiac issues).
18 Years
MALE
No
Sponsors
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The Institute of Cancer Research, Sutton, Surrey, UK
UNKNOWN
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Nicholas van As, MD
Role: STUDY_DIRECTOR
Royal Marsden NHS Foundation Trust, London, United Kingdom
Peter Ostler, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Vernon Cancer Centre, United Kingdom
Alison Tree, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust, London, United Kingdom
Locations
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Northeast Cancer Centre
Greater Sudbury, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Walker Family Cancer Centre
Niagara, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Hôpital Charles-LeMoyne
Montreal, Quebec, Canada
Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada
Beacon Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
St James's Hospital
Dublin, , Ireland
St. Luke's Hospital
Dublin, , Ireland
Auckland City Hospital
Auckland, , New Zealand
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, United Kingdom
Colchester General Hospital
Colchester, Essex, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Mount Vernon Cancer Centre
London, Surrey, United Kingdom
Velindre Cancer Centre
Cardiff, Wales, United Kingdom
University Hospital Coventry & Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom
Royal United Hospital
Bath, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Pilgrim Hospital
Boston, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
West Suffolk Hospital
Bury, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Queen Elizabeth Hospital
Cambridge, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Cheltenham General Hospital
Cheltenham, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Western General
Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
The Beatson
Glasgow, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Imperial College, London
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
North Middlesex University Hospital
London, , United Kingdom
Royal Marsden NHS Foundation Trust
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Maidstone Hospital
Maidstone, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Norfolk & Norwich Hospital
Norwich, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Glan Clwyd Hospital
Rhyl, , United Kingdom
Queens Hospital
Romford, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Kings Mill Hospital
Sutton in Ashfield, , United Kingdom
Torbay District General Hospital
Torquay, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Southend University Hospital
Westcliff-on-Sea, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
Countries
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References
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Tree AC, Hinder V, Chan A, Tolan S, Ostler P, van der Voet H, Kancherla K, Loblaw A, Naismith O, Jain S, Martin A, Price D, Brand D, Chu W, Duffton A, Kelly P, O'Neill B, Staffurth J, Sasso G, Pugh J, Manning G, Brown S, Burnett S, Griffin C, Hall E, van As N; PACE Investigators. Intensity-modulated moderately hypofractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-C): early toxicity results from a randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2025 Jul;26(7):936-947. doi: 10.1016/S1470-2045(25)00205-0. Epub 2025 Jun 12.
Smith RP, Mohammed MA, Beriwal S, Benoit RM. Prostate Brachytherapy With Cs-131: Long-term Results Compared With Published Stereotactic Body Radiotherapy Data. Am J Clin Oncol. 2025 Jan 1;48(1):34-37. doi: 10.1097/COC.0000000000001145. Epub 2024 Oct 17.
van As N, Griffin C, Tree A, Patel J, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Camilleri P, Kancherla K, Frew J, Chan A, Naismith O, Armstrong J, Staffurth J, Martin A, Dayes I, Wells P, Price D, Williamson E, Pugh J, Manning G, Brown S, Burnett S, Hall E. Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. N Engl J Med. 2024 Oct 17;391(15):1413-1425. doi: 10.1056/NEJMoa2403365.
Tree AC, Ostler P, van der Voet H, Chu W, Loblaw A, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Armstrong J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Duffton A, Brand DH, Henderson D, Morrison K, Brown S, Pugh J, Burnett S, Mahmud M, Hinder V, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2022 Oct;23(10):1308-1320. doi: 10.1016/S1470-2045(22)00517-4. Epub 2022 Sep 13.
Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Henderson D, Brown S, Cruickshank C, Burnett S, Duffton A, Griffin C, Hinder V, Morrison K, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019 Nov;20(11):1531-1543. doi: 10.1016/S1470-2045(19)30569-8. Epub 2019 Sep 17.
Related Links
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ICR Clinical Trials Unit - PACE website
Other Identifiers
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CCR3766
Identifier Type: -
Identifier Source: org_study_id
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