NCT01584258Active, not recruitingPhase 3
Prostate Advances in Comparative Evidence
International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer
Source: ClinicalTrials.gov · Last updated 19 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2205 (actual)
- First submitted
- 22 Apr 2012
- Start date
- 7 Aug 2012
- Primary completion date
- Dec 2025
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Diseases
- Prostate cancer
- NCT number
- NCT01584258
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2205
- From 7 Aug 2012 to the primary completion date, Dec 2025
- 68 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts.
- Participation in another concurrent treatment protocol for prostate cancer.
- Specific exclusion criteria for PACE-C:
- \>14 weeks of androgen deprivation therapy prior to randomisation
Other illness
- 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.
- 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.
- Medical conditions likely to make ADT inadvisable (e.g. significant and ongoing cardiac issues).
Age
- Life expectancy \<5 years.
Criteria the registry did not label
- Inclusion critieria (all arms):
- Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance and not clinically indicated)
- 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.
- Specific risk stratification inclusion criteria for PACE-A and PACE-B:
- 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)
- Specific risk stratification inclusion criteria for PACE-C:
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (68)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northeast Cancer Centre Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Hôpital Maisonneuve-Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hôpital Charles-LeMoyne Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Walker Family Cancer Centre Coordinator of this site? Confirm its status | Niagara | Canada | Unknown status |
| Lakeridge Health Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Royal United Hospital Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Pilgrim Hospital Coordinator of this site? Confirm its status | Boston | United Kingdom | Unknown status |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Bristol Haematology and Oncology Centre Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| West Suffolk Hospital Coordinator of this site? Confirm its status | Bury | United Kingdom | Unknown status |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Kent and Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Velindre Hospital Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Cheltenham General Hospital Coordinator of this site? Confirm its status | Cheltenham | United Kingdom | Unknown status |
| Colchester General Hospital Coordinator of this site? Confirm its status | Colchester | United Kingdom | Unknown status |
| University Hospital Coventry & Warwickshire NHS Trust Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Western General Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Royal Devon and Exeter Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| The Beatson Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Royal Surrey County Hospital Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Hinchingbrooke Hospital Coordinator of this site? Confirm its status | Huntingdon | United Kingdom | Unknown status |
| Ipswich Hospital Coordinator of this site? Confirm its status | Ipswich | United Kingdom | Unknown status |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Lincoln County Hospital Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Unknown status |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Mount Vernon Cancer Centre Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Charing Cross Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| North Middlesex University Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Maidstone Hospital Coordinator of this site? Confirm its status | Maidstone | United Kingdom | Unknown status |
| Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Unknown status |
| James Cook University Hospital Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Northampton General Hospital Coordinator of this site? Confirm its status | Northampton | United Kingdom | Unknown status |
| Norfolk & Norwich Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Peterborough City Hospital Coordinator of this site? Confirm its status | Peterborough | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Glan Clwyd Hospital Coordinator of this site? Confirm its status | Rhyl | United Kingdom | Unknown status |
| Queens Hospital Coordinator of this site? Confirm its status | Romford | United Kingdom | Unknown status |
| Weston Park Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Sunderland Royal Hospital Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Unknown status |
| Kings Mill Hospital Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Unknown status |
| Torbay District General Hospital Coordinator of this site? Confirm its status | Torquay | United Kingdom | Unknown status |
| Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Southend University Hospital Coordinator of this site? Confirm its status | Westcliff-on-Sea | United Kingdom | Unknown status |
| Worcestershire Royal Hospital Coordinator of this site? Confirm its status | Worcester | United Kingdom | Unknown status |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| St Luke's Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| St. James's Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Beacon Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.