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Brief Title: Prostate Advances in Comparative Evidence
Official Title: International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer
Study ID: NCT01584258
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Northeast Cancer Centre, Sudbury, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
Hôpital Maisonneuve Rosemont, Montreal, Quebec, Canada
Hôpital Charles-LeMoyne, Montréal, 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
James Cook University Hospital, Middlesborough, , 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
Clatterbridge Cancer Centre, Wirral, , United Kingdom
Worcestershire Royal Hospital, Worcester, , United Kingdom
Name: Nicholas van As, MD
Affiliation: Royal Marsden NHS Foundation Trust, London, United Kingdom
Role: STUDY_DIRECTOR
Name: Peter Ostler, MD
Affiliation: Mount Vernon Cancer Centre, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
Name: Alison Tree, MD
Affiliation: Royal Marsden NHS Foundation Trust, London, United Kingdom
Role: PRINCIPAL_INVESTIGATOR