Prostate Advances in Comparative Evidence
PACE
International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer
1 other identifier
interventional
2,205
4 countries
68
Brief Summary
This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Aug 2012
Longer than P75 for phase_3 prostate-cancer
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedStudy Start
First participant enrolled
August 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedJanuary 19, 2024
January 1, 2024
13.3 years
April 22, 2012
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PACE-B and PACE-C: Freedom from biochemical or clinical failure
Biochemical progression is defined as: Phoenix definition Clinical progression is defined as: commencement (PACE-B) or re-commencement (PACE-C) of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases
5 years from randomisation (primary timepoint)
PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother
Urinary incontinence assessed by the number of absorbent pads required per day to control leakage measured by The Expanded Prostate Cancer Index (EPIC) questionnaire. Bowel bother assessed by summary score from the EPIC questionnaire.
2 years from treatment (primary timepoint)
Secondary Outcomes (7)
All arms: Clinician reported acute toxicity
10 years
All arms: Clinician reported late toxicity
10 years
All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms.
10 years
All arms: Disease-specific and overall survival
10 years
All arms: Progression-free survival
10 years
- +2 more secondary outcomes
Study Arms (3)
PACE-A: Prostatectomy vs prostate SBRT
ACTIVE COMPARATORLow 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.
PACE-B: Conventionally Fractionated RT vs Prostate SBRT
ACTIVE COMPARATORLow 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.
PACE-C: Conventionally Fractionated RT vs Prostate SBRT
ACTIVE COMPARATORIntermediate 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.
Interventions
Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
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 delivered to a dose of 36.25 Gy in 5 fractions.
Eligibility Criteria
You may qualify if:
- 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
- +11 more criteria
You may not qualify if:
- Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
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
HĂ´pital Charles-LeMoyne
Montreal, Quebec, Canada
HĂ´pital 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, PE29 6NT, United Kingdom
Colchester General Hospital
Colchester, Essex, CO4 5JL, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Mount Vernon Cancer Centre
London, Surrey, HA6 2RN, United Kingdom
Velindre Cancer Centre
Cardiff, Wales, CF14 2TL, United Kingdom
University Hospital Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX, 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, NW3 2QC, United Kingdom
Imperial College, London
London, W12 0NN, 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
Related Publications (5)
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.
PMID: 40517778DERIVEDSmith 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.
PMID: 39716881DERIVEDvan 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.
PMID: 39413377DERIVEDTree 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.
PMID: 36113498DERIVEDBrand 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.
PMID: 31540791DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicholas van As, MD
Royal Marsden NHS Foundation Trust, London, United Kingdom
- PRINCIPAL INVESTIGATOR
Peter Ostler, MD
Mount Vernon Cancer Centre, United Kingdom
- PRINCIPAL INVESTIGATOR
Alison Tree, MD
Royal Marsden NHS Foundation Trust, London, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2012
First Posted
April 24, 2012
Study Start
August 7, 2012
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2027
Last Updated
January 19, 2024
Record last verified: 2024-01