Last updated on November 2018

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy


Brief description of study

The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-nave prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service.

Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process.

Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017)

  1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival.
  2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT.
  3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.

Detailed Study Description

STAMPEDE (also known as MRC PR08) is a multi-arm multi-stage (MAMS) randomised controlled trial recruiting in the UK and Switzerland. It aims to evaluate multiple therapeutic strategies in the management of high-risk locally advanced and metastatic hormone-nave prostate cancer. Each novel treatment strategy is compared against a single, contemporaneous control arm. When the trial originally opened in 2005 there were 6 research arms enabling 5 randomised comparisons. Each comparison is evaluated in stages with pre-planned interim analyses after which recruitment may be halted should the experimental treatment fail to reach a "hurdle" of activity. Patient data from all arms and all stages are, however, included in the final analyses of the primary outcome measure, even if the investigational arm did not proceed to the final stage.

Providing sufficient activity is demonstrated, recruitment continues to the final stage and then an assessment of efficacy is determined based on the primary outcome of overall survival. Patient data from all arms and all stages are included in the final analyses of the primary outcome measure, even if the investigational arm did not proceed to the final stage.

The original comparisons which have all now been reported, evaluated a bisphosphonate (zoledronic acid), a cytotoxic chemotherapeutic agent (docetaxel) and a cyclooxygenase (Cox 2) inhibitor (celecoxib), as single agents or combinations. Since the start of the trial, a number of new research arms have been added to STAMPEDE over time to evaluate: abiraterone, a steroid synthesis inhibitor; prostate radiotherapy for patients with newly diagnosed metastatic disease; enzalutamide, an inhibitor of androgen receptor signalling, given with abiraterone; and metformin, an anti-diabetic medication and transdermal oestradiol, to be given as an alternative form of ADT.

Objectives

Primary

To compare the safety and efficacy of novel therapeutic strategies against the current standard-of-care for men with high-risk locally advanced or metastatic prostate cancer starting long-term ADT for the first time.

Outline: This is a randomised, controlled, multi-centre MAMS trial platform. Patients are current randomised to 1 of 3 arms: control group (arm A), metformin treatment group (arm K) and transdermal oestradiol (Arm L). The other arms are all closed to recruitment with results known for all the original comparisons and awaited for others added since the trial commenced.

Patient population: STAMPEDE recruits both men with high-risk locally advanced prostate cancer and men with metastatic prostate cancer, all of whom must be starting long-term ADT for the first time. Patients who received previous radical treatment and are now relapsing with high-risk features are also eligible.

Follow-up: All patients are follow-up life long

Sub-studies: There are several translational sub-studies ongoing as part of STAMPEDE. Participation is optional. These currently include several translational sub-studies involving sample collection: saliva collection for germline DNA analysis, sequential circulating tumour DNA analysis and FFPE tumour block retrieval for DNA and RNA analysis. Other sub-studies include a QOL sub-study and an imaging sub-study.

Clinical Study Identifier: NCT00268476

Contact Investigators or Research Sites near you

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STAMPEDE Trial Team

Hirslanden Klinik Aarau
Aarau, Switzerland
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STAMPEDE Trial Team

Universitaetsspital-Basel
Basel, Switzerland
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STAMPEDE Trial Team

Kantonsspital Graubuenden
Chur, Switzerland
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STAMPEDE Trial Team

Lausanne Centre Hospitalier Universitaire
Lausanne, Switzerland
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STAMPEDE Trial Team

Liestal Hospital
Liestal, Switzerland
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STAMPEDE Trial Team

Kantonsspital - St. Gallen
St. Gallen, Switzerland
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STAMPEDE Trial Team

Winterthur Hospital
Winterthur, Switzerland
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STAMPEDE Trial Team

UniversitaetsSpital Zuerich
Zurich, Switzerland
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STAMPEDE Trial Team

City Hospital Triemli
Zurich, Switzerland
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William Harvey Hospital
Ashford, United Kingdom
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STAMPEDE Trial Team

Stoke Mandeville Hospital
Aylesbury, United Kingdom
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North Devon District Hospital
Barnstaple, United Kingdom
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Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, United Kingdom
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Royal United Hospital
Bath, United Kingdom
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City Hospital (Birmingham)
Birmingham, United Kingdom
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, United Kingdom
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Royal Bournemouth Hospital
Bournemouth, United Kingdom
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Bradford Royal Infirmary
Bradford, United Kingdom
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Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, United Kingdom
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Bristol Haematology and Oncology Centre
Bristol, United Kingdom
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Broomfield Hospital
Broomfield, United Kingdom
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Burnley General Hospital
Burnley, United Kingdom
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Queen's Hospital
Burton-upon-Trent, United Kingdom
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West Suffolk Hospital
Bury St. Edmunds, United Kingdom
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Kent and Canterbury Hospital
Canterbury, United Kingdom
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Cumberland Infirmary
Carlisle, United Kingdom
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Cheltenham General Hospital
Cheltenham, United Kingdom
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Countess of Chester Hospital
Chester, United Kingdom
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Queen Alexandra Hospital
Cosham, United Kingdom
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Castle Hill Hospital
Cottingham, United Kingdom
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Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, United Kingdom
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Darlington Memorial
Darlington, United Kingdom
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Derbyshire Royal Infirmary
Derby, United Kingdom
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Doncaster Royal Infirmary
Doncaster, United Kingdom
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Dorset County Hospital
Dorchester, United Kingdom
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Russells Hall Hospital
Dudley, United Kingdom
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University Hospital of North Durham
Durham, United Kingdom
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Eastbourne District General Hospital
Eastbourne, United Kingdom
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Royal Devon and Exeter Hospital
Exeter, United Kingdom
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Royal Bolton Hospital
Farnworth, United Kingdom
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Gloucestershire Royal Hospital
Gloucester, United Kingdom
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St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, United Kingdom
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Wycombe General Hospital
High Wycombe, United Kingdom
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Ipswich Hospital
Ipswich, United Kingdom
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Kidderminster Hospital
Kidderminster, United Kingdom
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Leeds Cancer Centre at St. James's University Hospital
Leeds, United Kingdom
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Glenfield Hospital
Leicester, United Kingdom
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Royal Liverpool University Hospital
Liverpool, United Kingdom
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University Hospital Aintree
Liverpool, United Kingdom
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UCL Cancer Institute
London, United Kingdom
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University College of London Hospitals
London, United Kingdom
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Charing Cross Hospital
London, United Kingdom
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Guy's Hospital
London, United Kingdom
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Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, United Kingdom
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Queen Elizabeth Hospital - Woolwich
London, United Kingdom
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St. George's Hospital
London, United Kingdom
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St. Mary's Hospital
London, United Kingdom
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Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, United Kingdom
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Withington Hospital
Manchester, United Kingdom
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Christie Hospital
Manchester, United Kingdom
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Queen Elizabeth The Queen Mother Hospital
Margate, United Kingdom
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James Cook University Hospital
Middlesbrough, United Kingdom
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Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, United Kingdom
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Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, United Kingdom
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Nottingham City Hospital
Nottingham, United Kingdom
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Royal Oldham Hospital
Oldham, United Kingdom
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Churchill Hospital
Oxford, United Kingdom
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Rosemere Cancer Centre at Royal Preston Hospital
Preston, United Kingdom
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Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, United Kingdom
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Queen's Hospital
Romford, United Kingdom
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Conquest Hospital
Saint Leonards-on-Sea, United Kingdom
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Scarborough General Hospital
Scarborough, United Kingdom
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Cancer Research Centre at Weston Park Hospital
Sheffield, United Kingdom
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Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
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South Tyneside District Hospital
South Shields, United Kingdom
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Southampton General Hospital
Southampton, United Kingdom
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Southport and Formby District General Hospital
Southport, United Kingdom
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Lister Hospital
Stevenage, United Kingdom
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Stepping Hill Hospital
Stockport, United Kingdom
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Sunderland Royal Hospital
Sunderland, United Kingdom
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King's Mill Hospital
Sutton-in-Ashfield, United Kingdom
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Great Western Hospital
Swindon, United Kingdom
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Musgrove Park Hospital
Taunton, United Kingdom
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Torbay Hospital
Torquay, United Kingdom
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Warrington Hospital NHS Trust
Warrington, United Kingdom
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Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, United Kingdom
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Weston General Hospital
Weston Super Mare, United Kingdom
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West Cumberland Hospital
Whitehaven, United Kingdom
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Worcester Royal Hospital
Worcester, United Kingdom
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Worthing Hospital
Worthing, United Kingdom
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St. Mary's Hospital
Newport, United Kingdom
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Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, United Kingdom
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Ayr Hospital
Ayr, United Kingdom
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Edinburgh Cancer Centre at Western General Hospital
Edinburgh, United Kingdom
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Beatson Institute for Cancer Research - Glasgow
Glasgow, United Kingdom
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Raigmore Hospital
Inverness, United Kingdom
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Bronglais General Hospital
Aberystwyth, United Kingdom
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Velindre Cancer Center at Velindre Hospital
Cardiff, United Kingdom
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Addenbrooke's Hospital
Cambridge, United Kingdom
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Forth Valley Hospital
Larbert, United Kingdom
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Lincoln Hospital
Lincoln, United Kingdom
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St. Bartholomews Hospital
London, United Kingdom
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Freeman Hospital
Newcastle, United Kingdom
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North Tees Hospital
Stockton-on-Tees, United Kingdom
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New Cross Hospital
Wolverhampton, United Kingdom
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Yeovil District Hospital
Yeovil, United Kingdom
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Inselspital Bern
Berne, Switzerland
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Poole Hospital
Poole, United Kingdom
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Hereford County Hospital
Hereford, United Kingdom
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Royal Albert Edward Infirmary
Wigan, United Kingdom
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Princess Alexandra Hospital
Harlow, United Kingdom
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South West Wales Cancer Institute At Singleton Hospital
Swansea, United Kingdom
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Airedale General Hospital
Steeton, United Kingdom
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Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
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STAMPEDE Trial Team

Royal Marsden - Sutton
Sutton, United Kingdom
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STAMPEDE Trial Team

Good Hope Hospital
Sutton Coldfield, United Kingdom
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Huddersfield Royal Infirmary
Huddersfield, United Kingdom
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Clatterbridge Centre for Oncology
Bebington, United Kingdom
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Barnet General Hospital
Barnet, United Kingdom
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Colchester General Hospital
Colchester, United Kingdom
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Recruitment Status: Open


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