Prostate Advances in Comparative Evidence
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Conventionally Fractionated Prostate RadiotherapyProcedure: ProstatectomyRadiation: Prostate SBRT
- Registration Number
- NCT01584258
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 2205
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PACE-A: Prostatectomy vs prostate SBRT 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. PACE-B: Conventionally Fractionated RT vs Prostate SBRT Conventionally Fractionated Prostate Radiotherapy 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. PACE-B: Conventionally Fractionated RT vs Prostate SBRT 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. PACE-C: Conventionally Fractionated RT vs Prostate SBRT Conventionally Fractionated Prostate Radiotherapy 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. PACE-C: Conventionally Fractionated RT vs Prostate SBRT 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. PACE-A: Prostatectomy vs prostate SBRT Prostatectomy 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.
- Primary Outcome Measures
Name Time Method PACE-B and PACE-C: Freedom from biochemical or clinical failure 5 years from randomisation (primary timepoint) 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 metastasesPACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother 2 years from treatment (primary timepoint) 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.
- Secondary Outcome Measures
Name Time Method All arms: Clinician reported acute toxicity 10 years CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).
All arms: Progression-free survival 10 years Radiographic, clinical or biochemical evidence of local or distant failure
All arms: Disease-specific and overall survival 10 years Disease-specific and overall survival
All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms. 10 years Assessed using International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), Vaizey score, and Expanded Prostate Index Composite-26 (EPIC-26) instruments.
All arms: Clinician reported late toxicity 10 years CTCAE and RTOG (SBRT and conventional RT patients only).
PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy 10 years LHRH analogues, anti-androgens, orchidectomy
PACE-A: Freedom from biochemical or clinical failure 5 years from randomisation (primary timepoint) Biochemical progression is defined as: Phoenix definition (SBRT arm) or \>0.2ng/ml (surgical arm)
Clinical progression is defined as: commencement of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases
Trial Locations
- Locations (67)
Hôpital Charles-LeMoyne
🇨🇦Montréal, Quebec, Canada
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
James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Velindre Cancer Centre
🇬🇧Cardiff, Wales, United Kingdom
Beaumont Hospital
🇮🇪Dublin, Ireland
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
St James's Hospital
🇮🇪Dublin, Ireland
Beacon Hospital
🇮🇪Dublin, Ireland
Hinchingbrooke Hospital
🇬🇧Huntingdon, Cambridgeshire, United Kingdom
St. Luke's Hospital
🇮🇪Dublin, Ireland
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
Walker Family Cancer Centre
🇨🇦Niagara, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Northeast Cancer Centre
🇨🇦Sudbury, Ontario, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Hôpital Maisonneuve Rosemont
🇨🇦Montreal, Quebec, Canada
Auckland City Hospital
🇳🇿Auckland, New Zealand
Colchester General Hospital
🇬🇧Colchester, Essex, United Kingdom
Mount Vernon Cancer Centre
🇬🇧London, Surrey, 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
🇬🇧Cambridge, United Kingdom
Pilgrim Hospital
🇬🇧Boston, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
West Suffolk Hospital
🇬🇧Bury, United Kingdom
Western General
🇬🇧Edinburgh, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Velindre Hospital
🇬🇧Cardiff, United Kingdom
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
The Beatson
🇬🇧Glasgow, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Imperial College, London
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
North Middlesex University Hospital
🇬🇧London, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
Peterborough City Hospital
🇬🇧Peterborough, United Kingdom
Norfolk & Norwich Hospital
🇬🇧Norwich, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, 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
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Kings Mill Hospital
🇬🇧Sutton In Ashfield, United Kingdom
Torbay District General Hospital
🇬🇧Torquay, United Kingdom
Southend University Hospital
🇬🇧Westcliff-on-Sea, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Wirral, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Charing Cross Hospital
🇬🇧London, United Kingdom