The PACE Study
| ISRCTN | ISRCTN17627211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17627211 |
| ClinicalTrials.gov (NCT) | NCT01584258 |
| Protocol serial number | 12628 |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Funder | Accuray Incorporated (USA) |
- Submission date
- 25/02/2015
- Registration date
- 25/02/2015
- Last edited
- 27/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
ICR Clinical Trials and Statistics Unit (ICR-CTSU)
Division of Clinical Studies
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 (0)20 8722 4261 |
|---|---|
| pace-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | International randomised study of laparoscopic prostatectomy vs stereotactic body radiotherapy (SBRT) and conventionally fractionated radiotherapy vs SBRT for early stage organ-confined prostate cancer |
| Study acronym | PACE |
| Study objectives | The aim of this study is to assess whether hypofractionated stereotactic body radiotherapy (SBRT) offers therapeutic benefit over prostatectomy or conventionally fractionated radiotherapy for people with early stage organ-confined prostate cancer. Profound hypofractionation with SBRT has the potential to achieve equivalent tumour control rates compared to surgery and conventional radiotherapy while reducing radiation to normal tissues (bladder, rectal and penile bulb) and minimising radiation-induced side effects. |
| Ethics approval(s) | Chelsea NRES, 25/01/12, ref: 11/LO/1915 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Current intervention as of 17/02/2020: 1. Radiotherapy: Conventionally fractionated radiotherapy: delivered to a dose of 60 Gy in 20 fractions (PACE-C) or 62 Gy in 20 fractions (PACE-B) 2. SBRT - hypofractionated stereotactic body radiotherapy: delivered to a dose of 36.25 Gy in 5 fractions 3. Surgery: prostatectomy surgery In PACE-A low- and intermediate-risk patients will be randomised between surgery (control) and SBRT. In PACE-B low- and intermediate-risk patients will be randomised between radiotherapy (control) and SBRT. In PACE-C intermediate- and high-risk patients will be randomised between radiotherapy (control) and SBRT. Previous intervention: 1. Radiotherapy: Conventionally fractionated radiotherapy: delivered to a dose of 78 Gy in 2 Gy fractions 2. SBRT - hypofractionated stereotactic body radiotherapy: delivered to a dose of 36.25 Gy in 5 fractions 3. Surgery: laparoscopic prostatectomy Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Current primary outcome measures as of 17/02/2020: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 17/02/2020: |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Male |
| Target sample size at registration | 1716 |
| Key inclusion criteria | 1. Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken within last 18 months. 2. Gleason score = 3+4 3. Men aged at least18 4. Clinical and MRI stage T1c –T2c, N0-X, M0-X 5. PSA = 20 ng/ml 6. Pre-enrollment PSA must be completed within 60 days of registration 7. Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network (www.nccn.org): 7.1. Low risk: Clinical stage T1-T2a and Gleason = 6 and PSA < 10 ng/ml, or 7.2. Intermediate risk includes any one of the following: 7.2.1. Clinical stage T2b orT2c 7.2.2. PSA 10-20 ng/ml 7.2.3. Gleason 7 8. WHO performance status 0 - 2 9. Prostate volume = 90 cc measured within 6 months of randomisation 10. Ability of the research subject to understand and the willingness to sign a written informed consent document |
| Key exclusion criteria | 1. Clinical stage T3 or greater 2. Gleason score = 4 + 3 3. High risk disease defined by National Comprehensive Cancer Network (www.nccn.org) 4. < 10 prostate biopsies taken 5. Previous malignancy within last 5 years except basal cell carcinoma or squamous cell carcinoma of the skin 6. Prior pelvic radiotherapy 7. Prior androgen deprivation therapy (including androgen agonists and antagonists) 8. Any prior active treatment for prostate cancer. Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria. 9. Prior transurethral resection of the prostate (TURP) for benign prostatic hypertrophy 10. Life expectancy <5 years 11. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts 12. Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms 13. Anticoagulation with warfarin/bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician. 14. Medical condition/ implant that prohibits MRI 15. Participation in another concurrent treatment protocol |
| Date of first enrolment | 01/08/2012 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
- Canada
- Ireland
Study participating centres
London
SW3 6JJ
England
The Clock Tower
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
England
Sutton
SM2 5PT
England
Kingston upon Thames
KT2 7QB
England
Headington
Oxford
OX3 7LE
England
Middlesbrough
TS4 3BW
England
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Belfast
BT9 7AB
Northern Ireland
Edgbaston
Birmingham
B15 2GW
England
Coventry
CV2 2DX
England
Cambridge
CB2 0QQ
England
Hinchingbrooke
PE29 6NT
England
Sunderland
SR4 7TP
England
Birkenhead
CH63 4JY
England
Bury St Edmunds
IP33 2QZ
England
Nottingham
NG5 1PB
England
London
EC1A 7BE
England
Leicester
LE1 5WW
England
Hammersmith
London
W6 8RF
England
Hampstead
London
NW3 2QG
England
Bloomsbury
London
NW1 2BU
England
Lincoln
LN2 5QY
England
Boston
PE21 9QS
England
Norwich
NR4 7UY
England
Cardiff
CF14 2TL
Wales
Bodelwyddan
Rhyl
LL18 5UJ
Wales
Broomhall
Sheffield
S10 2SJ
England
Glasgow
G12 0YN
Scotland
Westcliff-on-Sea
Southend-on-Sea
SS0 0RY
England
Mile End
Colchester
CO4 5JL
England
Truro
TR1 3LQ
England
Plymouth
PL6 8DH
England
Torquay
TQ2 7AA
England
Bristol
BS2 8ED
England
Manchester
M20 4BX
England
King's Lynn
PE30 4ET
England
Edinburgh
EH4 2XU
Scotland
Maidstone
ME16 9QQ
England
Taunton
TA1 5DA
England
London
N18 1QX
England
Guildford
GU2 7XX
England
Bracken Road
Sandyford Industrial Estate
Dublin
D18 AK68
Ireland
The Liberties
Dublin
D08 NHY1
Ireland
Dublin
D09 V2N0
Ireland
Highfield Road
Dublin
D06 HH36
Ireland
Toronto
M4N 3M5
Canada
Hamilton
L8V 5C2
Canada
Oshawa
L1G 2B9
Canada
Sudbury
P3E 5J1
Canada
St. Catharines
L2S 0A9
Canada
Greenfield Park
Longueuil
J4V 2H1
Canada
London
N6A 5W9
Canada
Ottawa
K1H 8L6
Canada
Montreal
H1T 2M4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | acute toxicity findings | 01/11/2019 | 20/06/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 28/02/2023 | No | Yes |
Editorial Notes
27/11/2025: The interventions were updated.
28/02/2023: Results in plain English uploaded to the trial outputs table.
20/06/2022: Publication reference added.
01/02/2021: The condition has been changed from "Topic: Cancer, Surgery; Subtopic: Prostate Cancer, Surgery; Disease: Prostate" to "Prostate cancer" following a request from the NIHR.
12/06/2020: Updated contact details.
17/02/2020: The following changes have been made:
1. The intervention has been changed.
2. The primary outcome measures have been changed.
3. The secondary outcome measures have been changed.
4. The recruitment end date has been changed from 01/09/2016 to 31/12/2022.
5. Royal Marsden Hospital Sutton, Kingston Hospital, Churchill Hospital, James Cook University Hospital, Freeman Hospital, Belfast City Hospital, Queen Elizabeth Hospital, University Hospital Coventry and Warwickshire, Addenbrooke's Hospital, Hinchingbrooke Hospital, Sunderland Royal Hospital, Clatterbridge Cancer Centre, West Suffolk Hospital, Nottingham City Hospital, St Bartholomew's Hospital, Leicester Royal Infirmary, Charing Cross Hospital, Royal Free Hospital, University College Hospital, Lincoln County Hospital, Pilgrim Hospital, Norfolk & Norwich University Hospital, Velindre Cancer Centre, Glan Clwyd Hospital, Weston Park Hospital, Beatson West of Scotland Cancer Centre, Southend University Hospital, Colchester Hospital, Royal Cornwall Hospital, Derriford Hospital, Torbay Hospital, Bristol Haematology and Oncology Centre, Christie Hospital, The Queen Elizabeth Hospital, Western General Hospital, Maidstone Hospital, Musgrove Park Hospital, North Middlesex University Hospital, Royal Surrey County Hospital, Beacon Hospital, St James's Hospital, Beaumont Hospital, St Luke's Hospital, Odette Cancer Centre, Juravinski Cancer Centre, Lakeridge Health, Northeast Cancer Centre, Walker Family Cancer Centre, Hôpital Charles-LeMoyne, London Health Sciences Centre, Ottawa Hospital and Hôpital Maisonneuve-Rosemont have been added to the trial participating centres.
10/04/2019: Publication reference added.
