Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
STAMPEDE
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial
6 other identifiers
interventional
11,992
2 countries
120
Brief Summary
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-naïve 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jul 2005
Longer than P75 for phase_2 prostate-cancer
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2005
CompletedFirst Submitted
Initial submission to the registry
December 20, 2005
CompletedFirst Posted
Study publicly available on registry
December 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
ExpectedApril 18, 2023
April 1, 2023
20.7 years
December 20, 2005
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Time to mortality
1:Not applicable
Secondary Outcomes (13)
Failure-free survival
1:Not applicable
Cost effectiveness by EuroQol
1:Not applicable
Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item
1:Not applicable
Number of participants with treatment-related side effects as assessed by CTCAE v4.0
1:Not applicable
Skeletal related events
1:Not applicable
- +8 more secondary outcomes
Study Arms (11)
Arm A: Standard of Care
ACTIVE COMPARATORAndrogen Deprivation Therapy \[ADT\] (plus Radiotherapy for newly-diagnosed non-metastatic disease, plus or minus Docetaxel, plus or minus Abiraterone)\[Control\]
Arm B: Zoledronic Acid
EXPERIMENTAL(ADT + zoledronic acid) NO LONGER RECRUITING
Arm C: Docetaxel
EXPERIMENTAL(ADT + docetaxel + prednisolone) NO LONGER RECRUITING
Arm D: Celecoxib
EXPERIMENTAL(ADT + celecoxib) NO LONGER RECRUITING
Arm E: Zoledronic Acid & Docetaxel
EXPERIMENTAL(ADT + zoledronic acid + docetaxel + prednisolone) NO LONGER RECRUITING
Arm F: Zoledronic Acid & Celecoxib
EXPERIMENTAL(ADT + zoledronic acid + celecoxib) NO LONGER RECRUITING
Arm G: Abiraterone
EXPERIMENTAL(ADT + abiraterone acetate + prednisolone) NO LONGER RECRUITING
Arm H: M1 RT
EXPERIMENTAL(ADT + radiotherapy to the prostate) NO LONGER RECRUITING
Arm J: Abiraterone * Enzalutamide
EXPERIMENTAL(ADT + abiraterone + enzalutamide + Prednisolone) NO LONGER RECRUITING
Arm K: Metformin
EXPERIMENTAL(ADT + Metformin) RECRUITING IN SELECTED SITES
Arm L: tE2
EXPERIMENTAL(Transdermal oestradiol) RECRUITING
Interventions
Eligibility Criteria
You may qualify if:
- High-Risk Newly-Diagnosed Non-Metastatic Node-Negative (N0/Nx) Disease
- Both:
- At least two of: T category T3/4, PSA≥40ng/ml or Gleason sum score 8-10
- Intention to treat with radical radiotherapy (unless there is a contra-indication)
- Newly-Diagnosed Metastatic Or Node-Positive Disease
- At least one of:
- Stage Tany N+ M0
- Stage Tany Nany M+
- Previously Radically Treated, Now Relapsing (Prior Radical Surgery And/or Radiotherapy)
- At least one of:
- PSA ≥4ng/ml and rising with doubling time less than 6 months
- PSA ≥20ng/ml
- AND
- <!-- -->
- Histologically confirmed prostate adenocarcinoma
- +11 more criteria
You may not qualify if:
- Patients must not fulfil any of the criteria below:
- Prior systemic therapy for locally-advanced or metastatic prostate cancer (1) (except as listed in the protocol section 4.3)
- Prior exposure to hormone therapy for a duration of \> 12 months, or prior exposure completing \< 12 months before randomisation (see section 4.3.1 for permitted prior exposure details)
- Metastatic brain disease or leptomeningeal disease
- Abnormal liver functions consisting of any of the following:
- Serum bilirubin ≥1.5 x ULN (except for patients with Gilbert's disease, for whom the upper limit of serum bilirubin is 51.3μmol/l or 3mg/dl)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN - site must indicate at randomisation whether one or both tests are performed at site. Where both results are available both must confirm eligibility.
- Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
- Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment
- Participant with significant cardiovascular disease, including:
- Severe/unstable angina
- Myocardial infarction less than 6 months prior to randomisation
- Arterial thrombotic events less than 6 months prior to randomisation
- Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class II or above (1)
- Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 6 months prior to randomisation
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
Lausanne Centre Hospitalier Universitaire
Lausanne, Canton of Vaud, CH-1011, Switzerland
Winterthur Hospital
Winterthur, Canton of Zurich, CH-8401, Switzerland
Kantonsspital Graubuenden
Chur, Kanton Graubünden, CH-7000, Switzerland
Hirslanden Klinik Aarau
Aarau, CH-5000, Switzerland
Universitaetsspital-Basel
Basel, CH-4031, Switzerland
Inselspital Bern
Bern, CH-3010 Be, Switzerland
Liestal Hospital
Liestal, CH-4410, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007, Switzerland
UniversitaetsSpital Zuerich
Zurich, CH-8091, Switzerland
City Hospital Triemli
Zurich, Switzerland
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN, United Kingdom
Royal Bolton Hospital
Farnworth, Bolton, BL4 0JR, United Kingdom
Wycombe General Hospital
High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Broomfield Hospital
Broomfield, Chelmsford, CM1 7ET, United Kingdom
Countess of Chester Hospital
Chester, Chesire, CH2 1UL, United Kingdom
James Cook University Hospital
Middlesbrough, County Durham, TS4 3BW, United Kingdom
Cumberland Infirmary
Carlisle, Cumbria, CA2 7HY, United Kingdom
North Devon District Hospital
Barnstaple, Devon, EX31 4JB, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Dorset County Hospital
Dorchester, Dorset, DT1 2JY, United Kingdom
Poole Hospital
Poole, Dorset, BH15 2JB, United Kingdom
Castle Hill Hospital
Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, East Sussex, TN37 7PT, United Kingdom
William Harvey Hospital
Ashford, England, TN24 0LZ, United Kingdom
Stoke Mandeville Hospital
Aylesbury, England, HP21 8AL, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA, United Kingdom
City Hospital (Birmingham)
Birmingham, England, B18 7QH, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE, United Kingdom
Burnley General Hospital
Burnley, England, BB10 2PQ, United Kingdom
Queen's Hospital
Burton-on-Trent, England, DE13 0RB, United Kingdom
West Suffolk Hospital
Bury St Edmunds, England, IP33 2QZ, United Kingdom
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, CW1 4QJ, United Kingdom
Darlington Memorial
Darlington, England, DL3 6HX, United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE22 3NE, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT, United Kingdom
Russells Hall Hospital
Dudley, England, DY1 2HQ, United Kingdom
University Hospital of North Durham
Durham, England, DH1 5TW, United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, GL1 3NN, United Kingdom
Hereford County Hospital
Hereford, England, HR1 2ER, United Kingdom
Kidderminster Hospital
Kidderminster, England, DY11 6RJ, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Glenfield Hospital
Leicester, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, L7 8XP, United Kingdom
University Hospital Aintree
Liverpool, England, L9 7AL, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX, United Kingdom
Guy's Hospital
London, England, SE1 9RT, United Kingdom
St. Mary's Hospital
London, England, W2 1NY, United Kingdom
UCL Cancer Institute
London, England, WC1E 6DD, United Kingdom
University College of London Hospitals
London, England, WIT 3AA, United Kingdom
Withington Hospital
Manchester, England, M20 8LR, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ, United Kingdom
Stepping Hill Hospital
Stockport, England, SK2 7JE, United Kingdom
Sunderland Royal Hospital
Sunderland, England, SR4 7TP, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
Warrington Hospital NHS Trust
Warrington, England, WA5 1QG, United Kingdom
West Cumberland Hospital
Whitehaven, England, CA28 8JG, United Kingdom
Royal Albert Edward Infirmary
Wigan, England, WN1 2NN, United Kingdom
Worcester Royal Hospital
Worcester, England, WR5 1DD, United Kingdom
Worthing Hospital
Worthing, England, BN11 2DH, United Kingdom
Princess Alexandra Hospital
Harlow, Essex, CM20 1QX, United Kingdom
Queen's Hospital
Romford, Essex, RM7 0AG, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
South West Wales Cancer Institute At Singleton Hospital
Swansea, Glamorgan, SA2 8QA, United Kingdom
Cheltenham General Hospital
Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
St. Bartholomews Hospital
London, Greater London, EC1A 7BE, United Kingdom
Queen Elizabeth Hospital - Woolwich
London, Greater London, SE18 4QH, United Kingdom
St. George's Hospital
London, Greater London, SW17 0QT, United Kingdom
Charing Cross Hospital
London, Greater London, W6 8RF, United Kingdom
Christie Hospital
Manchester, Greater Manchester, M20 4BX, United Kingdom
Royal Oldham Hospital
Oldham, Greater Manchester, OL1 2JH, United Kingdom
Southampton General Hospital
Southampton, Hampshire, S016 6YD, United Kingdom
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Raigmore Hospital
Inverness, Highland, IV2 3UJ, United Kingdom
St. Mary's Hospital
Newport, Isle Of Wight, PO30 5TG, United Kingdom
Airedale General Hospital
Steeton, Keighley, BD20 6TD, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, CT1 3NG, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, Kent, CT9 4AN, United Kingdom
Beatson Institute for Cancer Research - Glasgow
Glasgow, Lanarkshire, G12 0YN, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, Lancashire, PR2 4QF, United Kingdom
Southport and Formby District General Hospital
Southport, Merseyside, PR8 6PN, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Midlothian, EH4 2XU, United Kingdom
Freeman Hospital
Newcastle, Newcastle-upon-Tyne, NE7 7DN, United Kingdom
Scarborough General Hospital
Scarborough, North Yorkshire, YO12 6QL, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7AB, United Kingdom
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Queen Alexandra Hospital
Cosham, Portsmouth, P06 3LY, United Kingdom
Ayr Hospital
Ayr, Scotland, KA6 6DX, United Kingdom
Royal United Hospital
Bath, Somerset, BA1 3NG, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Somerset, BS2 8ED, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
Weston General Hospital
Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom
Yeovil District Hospital
Yeovil, Somerset, BA21 4AT, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, South Yorkshire, S10 2SJ, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Royal Marsden - Sutton
Sutton, Surrey, SM2 5PT, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, Tyne & Wear, NE4 6BE, United Kingdom
South Tyneside District Hospital
South Shields, Tyne & Wear, NE34 0PL, United Kingdom
Bronglais General Hospital
Aberystwyth, Wales, SY23 1ER, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, West Midlands, B15 2TH, United Kingdom
Good Hope Hospital
Sutton Coldfield, West Midlands, B75 7RR, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
Great Western Hospital
Swindon, Wiltshire, SN3 6BB, United Kingdom
Clatterbridge Centre for Oncology
Bebington, Wirral, CH63 4JY, United Kingdom
Barnet General Hospital
Barnet, EN5 3DJ, United Kingdom
Colchester General Hospital
Colchester, CO4 5JL, United Kingdom
Forth Valley Hospital
Larbert, FK5 4WR, United Kingdom
Lincoln Hospital
Lincoln, LN2 5QY, United Kingdom
North Tees Hospital
Stockton-on-Tees, TS19 8PE, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (30)
Sydes MR, Parmar MK, James ND, Clarke NW, Dearnaley DP, Mason MD, Morgan RC, Sanders K, Royston P. Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials. 2009 Jun 11;10:39. doi: 10.1186/1745-6215-10-39.
PMID: 19519885BACKGROUNDSydes MR, Parmar MK, Mason MD, Clarke NW, Amos C, Anderson J, de Bono J, Dearnaley DP, Dwyer J, Green C, Jovic G, Ritchie AW, Russell JM, Sanders K, Thalmann G, James ND. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials. 2012 Sep 15;13:168. doi: 10.1186/1745-6215-13-168.
PMID: 22978443BACKGROUNDParker CC, Sydes MR, Mason MD, Clarke NW, Aebersold D, de Bono JS, Dearnaley DP, Ritchie AW, Russell JM, Thalmann G, Parmar MK, James ND. Prostate radiotherapy for men with metastatic disease: a new comparison in the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) trial. BJU Int. 2013 May;111(5):697-9. doi: 10.1111/bju.12087. No abstract available.
PMID: 23578233BACKGROUNDAttard G, Sydes MR, Mason MD, Clarke NW, Aebersold D, de Bono JS, Dearnaley DP, Parker CC, Ritchie AW, Russell JM, Thalmann G, Cassoly E, Millman R, Matheson D, Schiavone F, Spears MR, Parmar MK, James ND. Combining enzalutamide with abiraterone, prednisone, and androgen deprivation therapy in the STAMPEDE trial. Eur Urol. 2014 Nov;66(5):799-802. doi: 10.1016/j.eururo.2014.05.038. Epub 2014 Jun 27.
PMID: 24985962BACKGROUNDJames ND, Spears MR, Clarke NW, Dearnaley DP, De Bono JS, Gale J, Hetherington J, Hoskin PJ, Jones RJ, Laing R, Lester JF, McLaren D, Parker CC, Parmar MKB, Ritchie AWS, Russell JM, Strebel RT, Thalmann GN, Mason MD, Sydes MR. Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019). Eur Urol. 2015 Jun;67(6):1028-1038. doi: 10.1016/j.eururo.2014.09.032. Epub 2014 Oct 6.
PMID: 25301760BACKGROUNDJames ND, Spears MR, Clarke NW, Dearnaley DP, Mason MD, Parker CC, Ritchie AW, Russell JM, Schiavone F, Attard G, de Bono JS, Birtle A, Engeler DS, Elliott T, Matheson D, O'Sullivan J, Pudney D, Srihari N, Wallace J, Barber J, Syndikus I, Parmar MK, Sydes MR; STAMPEDE Investigators. Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer: Data From Patients in the Control Arm of the STAMPEDE Trial. JAMA Oncol. 2016 Mar;2(3):348-57. doi: 10.1001/jamaoncol.2015.4350.
PMID: 26606329BACKGROUNDGillessen S, Gilson C, James N, Adler A, Sydes MR, Clarke N; STAMPEDE Trial Management Group. Repurposing Metformin as Therapy for Prostate Cancer within the STAMPEDE Trial Platform. Eur Urol. 2016 Dec;70(6):906-908. doi: 10.1016/j.eururo.2016.07.015. Epub 2016 Jul 19.
PMID: 27450106BACKGROUNDGilbert DC, Duong T, Sydes M, Bara A, Clarke N, Abel P, James N, Langley R, Parmar M; STAMPEDE and PATCH Trial Management Groups. Transdermal oestradiol as a method of androgen suppression for prostate cancer within the STAMPEDE trial platform. BJU Int. 2018 May;121(5):680-683. doi: 10.1111/bju.14153. Epub 2018 Feb 28. No abstract available.
PMID: 29388336BACKGROUNDParmar MK, Barthel FM, Sydes M, Langley R, Kaplan R, Eisenhauer E, Brady M, James N, Bookman MA, Swart AM, Qian W, Royston P. Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst. 2008 Sep 3;100(17):1204-14. doi: 10.1093/jnci/djn267. Epub 2008 Aug 26.
PMID: 18728279BACKGROUNDJames ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Anderson J, Popert RJ, Sanders K, Morgan RC, Stansfeld J, Dwyer J, Masters J, Parmar MK. Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial. BJU Int. 2009 Feb;103(4):464-9. doi: 10.1111/j.1464-410X.2008.08034.x. Epub 2008 Oct 8.
PMID: 18990168RESULTJames ND, Sydes MR, Mason MD, Clarke NW, Anderson J, Dearnaley DP, Dwyer J, Jovic G, Ritchie AW, Russell JM, Sanders K, Thalmann GN, Bertelli G, Birtle AJ, O'Sullivan JM, Protheroe A, Sheehan D, Srihari N, Parmar MK; STAMPEDE investigators. Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial. Lancet Oncol. 2012 May;13(5):549-58. doi: 10.1016/S1470-2045(12)70088-8. Epub 2012 Mar 26.
PMID: 22452894RESULTVale CL, Burdett S, Rydzewska LHM, Albiges L, Clarke NW, Fisher D, Fizazi K, Gravis G, James ND, Mason MD, Parmar MKB, Sweeney CJ, Sydes MR, Tombal B, Tierney JF; STOpCaP Steering Group. Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data. Lancet Oncol. 2016 Feb;17(2):243-256. doi: 10.1016/S1470-2045(15)00489-1. Epub 2015 Dec 21.
PMID: 26718929RESULTMason MD, Clarke NW, James ND, Dearnaley DP, Spears MR, Ritchie AWS, Attard G, Cross W, Jones RJ, Parker CC, Russell JM, Thalmann GN, Schiavone F, Cassoly E, Matheson D, Millman R, Rentsch CA, Barber J, Gilson C, Ibrahim A, Logue J, Lydon A, Nikapota AD, O'Sullivan JM, Porfiri E, Protheroe A, Srihari NN, Tsang D, Wagstaff J, Wallace J, Walmsley C, Parmar MKB, Sydes MR; STAMPEDE Investigators. Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naive Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial. J Clin Oncol. 2017 May 10;35(14):1530-1541. doi: 10.1200/JCO.2016.69.0677. Epub 2017 Mar 13.
PMID: 28300506RESULTJames ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.
PMID: 28578639RESULTSydes MR, Spears MR, Mason MD, Clarke NW, Dearnaley DP, de Bono JS, Attard G, Chowdhury S, Cross W, Gillessen S, Malik ZI, Jones R, Parker CC, Ritchie AWS, Russell JM, Millman R, Matheson D, Amos C, Gilson C, Birtle A, Brock S, Capaldi L, Chakraborti P, Choudhury A, Evans L, Ford D, Gale J, Gibbs S, Gilbert DC, Hughes R, McLaren D, Lester JF, Nikapota A, O'Sullivan J, Parikh O, Peedell C, Protheroe A, Rudman SM, Shaffer R, Sheehan D, Simms M, Srihari N, Strebel R, Sundar S, Tolan S, Tsang D, Varughese M, Wagstaff J, Parmar MKB, James ND; STAMPEDE Investigators. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Ann Oncol. 2018 May 1;29(5):1235-1248. doi: 10.1093/annonc/mdy072.
PMID: 29529169RESULTParker CC, James ND, Brawley CD, Clarke NW, Hoyle AP, Ali A, Ritchie AWS, Attard G, Chowdhury S, Cross W, Dearnaley DP, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Russell JM, Thalmann GN, Amos CL, Alonzi R, Bahl A, Birtle A, Din O, Douis H, Eswar C, Gale J, Gannon MR, Jonnada S, Khaksar S, Lester JF, O'Sullivan JM, Parikh OA, Pedley ID, Pudney DM, Sheehan DJ, Srihari NN, Tran ATH, Parmar MKB, Sydes MR; Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. Epub 2018 Oct 21.
PMID: 30355464RESULTClarke NW, Ali A, Ingleby FC, Hoyle A, Amos CL, Attard G, Brawley CD, Calvert J, Chowdhury S, Cook A, Cross W, Dearnaley DP, Douis H, Gilbert D, Gillessen S, Jones RJ, Langley RE, MacNair A, Malik Z, Mason MD, Matheson D, Millman R, Parker CC, Ritchie AWS, Rush H, Russell JM, Brown J, Beesley S, Birtle A, Capaldi L, Gale J, Gibbs S, Lydon A, Nikapota A, Omlin A, O'Sullivan JM, Parikh O, Protheroe A, Rudman S, Srihari NN, Simms M, Tanguay JS, Tolan S, Wagstaff J, Wallace J, Wylie J, Zarkar A, Sydes MR, Parmar MKB, James ND. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. Ann Oncol. 2019 Dec 1;30(12):1992-2003. doi: 10.1093/annonc/mdz396.
PMID: 31560068RESULTGillessen S, Murphy L, James ND, Sachdeva A, El-Taji O, Abdel-Aty H, Adler AI, Amos C, Attard G, Varughese M, Gale J, Brown S, Srihari N, Birtle AJ, Brown M, Chan K, Chowdhury S, Cross W, Dearnaley DP, Din O, Dutey-Magni P, Gilbert DC, Gilson C, Gray S, Grist E, Hofmann U, Hudson AM, Jain Y, Jeyasangar G, Jones R, Kayani M, Langley RE, Malik Z, Mason MD, Matheson D, McAlpine C, Macnair A, Millman R, Murphy C, Padden-Modi M, Parikh O, Parker C, Rush H, Russell M, Srinivasan R, Sundar S, Tanguay JS, Turco F, Williams P, Sydes MR, Parmar MKB, Brown LC, Clarke NW; STAMPEDE investigators. Metformin for patients with metastatic prostate cancer starting androgen deprivation therapy: a randomised phase 3 trial of the STAMPEDE platform protocol. Lancet Oncol. 2025 Aug;26(8):1018-1030. doi: 10.1016/S1470-2045(25)00231-1. Epub 2025 Jul 7.
PMID: 40639383DERIVEDParker CTA, Mendes L, Liu VYT, Grist E, Joun S, Yamashita R, Mitani A, Chen E, Parry MA, Sachdeva A, Murphy L, Huang HC, Griffin J, van der Wal D, Todorovic T, Lall S, Santos Vidal S, Goncalves M, Thakali S, Wingate A, Zakka L, Brown M, Wetterskog D, Amos CL, Atako NB, Jones RJ, Cross WR, Gillessen S, Parker CC; STAMPEDE collaborators; Berney DM, Tran PT, Spratt DE, Sydes MR, Parmar MKB, Clarke NW, Brown LC, Feng FY, Esteva A, James ND, Attard G. External validation of a digital pathology-based multimodal artificial intelligence-derived prognostic model in patients with advanced prostate cancer starting long-term androgen deprivation therapy: a post-hoc ancillary biomarker study of four phase 3 randomised controlled trials of the STAMPEDE platform protocol. Lancet Digit Health. 2025 Jul;7(7):100885. doi: 10.1016/j.landig.2025.100885. Epub 2025 Jun 3.
PMID: 40467357DERIVEDGilbert DC, Nankivell M, Rush H, Clarke NW, Mangar S, Al-Hasso A, Rosen S, Kockelbergh R, Sundaram SK, Dixit S, Laniado M, McPhail N, Shaheen A, Brown S, Gale J, Deighan J, Marshall J, Duong T, Macnair A, Griffiths A, Amos CL, Sydes MR, James ND, Parmar MKB, Langley RE. A Repurposing Programme Evaluating Transdermal Oestradiol Patches for the Treatment of Prostate Cancer Within the PATCH and STAMPEDE Trials: Current Results and Adapting Trial Design. Clin Oncol (R Coll Radiol). 2024 Jan;36(1):e11-e19. doi: 10.1016/j.clon.2023.10.054. Epub 2023 Nov 8.
PMID: 37973477DERIVEDAttard G, Murphy L, Clarke NW, Sachdeva A, Jones C, Hoyle A, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Gilson C, Rush H, Abdel-Aty H, Amos CL, Murphy C, Chowdhury S, Malik Z, Russell JM, Parkar N, Pugh C, Diaz-Montana C, Pezaro C, Grant W, Saxby H, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzouebi M, Parikh O, Robinson A, Montazeri AH, Wylie J, Zarkar A, Cathomas R, Brown MD, Jain Y, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; STAMPEDE investigators. Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. Lancet Oncol. 2023 May;24(5):443-456. doi: 10.1016/S1470-2045(23)00148-1.
PMID: 37142371DERIVEDGrist E, Friedrich S, Brawley C, Mendes L, Parry M, Ali A, Haran A, Hoyle A, Gilson C, Lall S, Zakka L, Bautista C, Landless A, Nowakowska K, Wingate A, Wetterskog D, Hasan AMM, Akato NB, Richmond M, Ishaq S, Matthews N, Hamid AA, Sweeney CJ, Sydes MR, Berney DM, Lise S; STAMPEDE investigators; Parmar MKB, Clarke NW, James ND, Cremaschi P, Brown LC, Attard G. Accumulation of copy number alterations and clinical progression across advanced prostate cancer. Genome Med. 2022 Sep 5;14(1):102. doi: 10.1186/s13073-022-01080-4.
PMID: 36059000DERIVEDParker CC, James ND, Brawley CD, Clarke NW, Ali A, Amos CL, Attard G, Chowdhury S, Cook A, Cross W, Dearnaley DP, Douis H, Gilbert DC, Gilson C, Gillessen S, Hoyle A, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Rauchenberger M, Rush H, Russell JM, Sweeney H, Bahl A, Birtle A, Capaldi L, Din O, Ford D, Gale J, Henry A, Hoskin P, Kagzi M, Lydon A, O'Sullivan JM, Paisey SA, Parikh O, Pudney D, Ramani V, Robson P, Srihari NN, Tanguay J, Parmar MKB, Sydes MR; STAMPEDE Trial Collaborative Group. Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial. PLoS Med. 2022 Jun 7;19(6):e1003998. doi: 10.1371/journal.pmed.1003998. eCollection 2022 Jun.
PMID: 35671327DERIVEDAttard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Amos CL, Atako N, Pugh C, Buckner M, Chowdhury S, Malik Z, Russell JM, Gilson C, Rush H, Bowen J, Lydon A, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzoueb M, Parikh O, Robinson A, Syndikus I, Wylie J, Zarkar A, Thalmann G, de Bono JS, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022 Jan 29;399(10323):447-460. doi: 10.1016/S0140-6736(21)02437-5. Epub 2021 Dec 23.
PMID: 34953525DERIVEDRush HL, Murphy L, Morgans AK, Clarke NW, Cook AD, Attard G, Macnair A, Dearnaley DP, Parker CC, Russell JM, Gillessen S, Matheson D, Millman R, Brawley CD, Pugh C, Tanguay JS, Jones RJ, Wagstaff J, Rudman S, O'Sullivan JM, Gale J, Birtle A, Protheroe A, Gray E, Perna C, Tolan S, McPhail N, Malik ZI, Vengalil S, Fackrell D, Hoskin P, Sydes MR, Chowdhury S, Gilbert DC, Parmar MKB, James ND, Langley RE. Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial. J Clin Oncol. 2022 Mar 10;40(8):825-836. doi: 10.1200/JCO.21.00728. Epub 2021 Nov 10.
PMID: 34757812DERIVEDAli A, Hoyle A, Haran AM, Brawley CD, Cook A, Amos C, Calvert J, Douis H, Mason MD, Dearnaley D, Attard G, Gillessen S, Parmar MKB, Parker CC, Sydes MR, James ND, Clarke NW. Association of Bone Metastatic Burden With Survival Benefit From Prostate Radiotherapy in Patients With Newly Diagnosed Metastatic Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):555-563. doi: 10.1001/jamaoncol.2020.7857.
PMID: 33599706DERIVEDJakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.
PMID: 33270906DERIVEDRoy S, Malone S, Grimes S, Morgan SC. Impact of Concomitant Medications on Biochemical Outcome in Localised Prostate Cancer Treated with Radiotherapy and Androgen Deprivation Therapy. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):181-190. doi: 10.1016/j.clon.2020.09.005. Epub 2020 Sep 29.
PMID: 32994091DERIVEDJames ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.
PMID: 26719232DERIVEDHuang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
PMID: 22747660DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicholas D. James, MD
Institute of Cancer Research, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Research Council
Study Record Dates
First Submitted
December 20, 2005
First Posted
December 22, 2005
Study Start
July 8, 2005
Primary Completion
March 1, 2026
Study Completion (Estimated)
December 1, 2030
Last Updated
April 18, 2023
Record last verified: 2023-04