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

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ClinicalTrials.gov Identifier: NCT00268476
Recruitment Status : Recruiting
First Posted : December 22, 2005
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medical Research Council

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Celecoxib Drug: Docetaxel Drug: Prednisolone Drug: ADT Drug: Zoledronic Acid Drug: Abiraterone Radiation: Radiotherapy to the prostate Drug: Enzalutamide Drug: Metformin Drug: Transdermal Oestradiol Phase 2 Phase 3

Detailed 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-naïve 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-arm Multi-Stage
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial
Actual Study Start Date : July 8, 2005
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm A: Standard of Care
Androgen Deprivation Therapy [ADT] (plus Radiotherapy for newly-diagnosed non-metastatic disease, plus or minus Docetaxel, plus or minus Abiraterone)[Control]
Drug: ADT
Other Name: Androgen Deprivation Therapy
Experimental: Arm B: Zoledronic Acid
(ADT + zoledronic acid) NO LONGER RECRUITING
Drug: ADT
Other Name: Androgen Deprivation Therapy
Drug: Zoledronic Acid
Other Name: Zometa
Experimental: Arm C: Docetaxel
(ADT + docetaxel + prednisolone) NO LONGER RECRUITING
Drug: Docetaxel
Other Name: Taxotere
Drug: Prednisolone
Other Name: Prednisone
Drug: ADT
Other Name: Androgen Deprivation Therapy
Experimental: Arm D: Celecoxib
(ADT + celecoxib) NO LONGER RECRUITING
Drug: Celecoxib
Other Name: Celebrex
Drug: ADT
Other Name: Androgen Deprivation Therapy
Experimental: Arm E: Zoledronic Acid & Docetaxel
(ADT + zoledronic acid + docetaxel + prednisolone) NO LONGER RECRUITING
Drug: Docetaxel
Other Name: Taxotere
Drug: Prednisolone
Other Name: Prednisone
Drug: ADT
Other Name: Androgen Deprivation Therapy
Drug: Zoledronic Acid
Other Name: Zometa
Experimental: Arm F: Zoledronic Acid & Celecoxib
(ADT + zoledronic acid + celecoxib) NO LONGER RECRUITING
Drug: Celecoxib
Other Name: Celebrex
Drug: ADT
Other Name: Androgen Deprivation Therapy
Drug: Zoledronic Acid
Other Name: Zometa
Experimental: Arm G: Abiraterone
(ADT + abiraterone acetate + prednisolone) NO LONGER RECRUITING
Drug: Prednisolone
Other Name: Prednisone
Drug: ADT
Other Name: Androgen Deprivation Therapy
Drug: Abiraterone
Other Name: Zytiga
Experimental: Arm H: M1 RT
(ADT + radiotherapy to the prostate) NO LONGER RECRUITING
Drug: ADT
Other Name: Androgen Deprivation Therapy
Radiation: Radiotherapy to the prostate
Other Name: RT
Experimental: Arm J: Abiraterone * Enzalutamide
(ADT + abiraterone + enzalutamide + Prednisolone) NO LONGER RECRUITING
Drug: Prednisolone
Other Name: Prednisone
Drug: ADT
Other Name: Androgen Deprivation Therapy
Drug: Abiraterone
Other Name: Zytiga
Drug: Enzalutamide
Other Name: Xtandi
Experimental: Arm K: Metformin
(ADT + Metformin) RECRUITING
Drug: ADT
Other Name: Androgen Deprivation Therapy
Drug: Metformin
Other Name: Metformin Hydrochloride
Experimental: Arm L: tE2
(Transdermal oestradiol) RECRUITING
Drug: Transdermal Oestradiol
Other Name: Progynova TS



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1:Not applicable ]
    Time to mortality


Secondary Outcome Measures :
  1. Failure-free survival [ Time Frame: 1:Not applicable ]
    Time to progression event

  2. Cost effectiveness by EuroQol [ Time Frame: 1:Not applicable ]
    Comparison of additional costs and survival gain to SOC.

  3. Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item [ Time Frame: 1:Not applicable ]
    Determination of changes in quality of life with interventions

  4. Toxicity [ Time Frame: 1:Not applicable ]
    Incidence and types of IMP toxicities

  5. Skeletal related events [ Time Frame: 1:Not applicable ]
    Incidence and types of skeletal related events

  6. Biochemical failure [ Time Frame: 1:Not applicable ]

    For the purposes of the STAMPEDE trial, a unique threshold PSA value for biochemical failure is calculated for each patient, referred to as the PSA progression value.

    A. If PSA nadir in the 24 weeks following randomisation is more than 4ng/ml and more than 50% of the pre-treatment PSA level - immediate treatment failure.

    B. If PSA nadir in the 24 weeks following randomisation is less than or equal to 50% of the pre-treatment PSA level but remains above 4ng/ml - treatment failure will be defined as a rise of 50% above the nadir level.

    C. If PSA nadir in the 24 weeks following randomisation is less than or equal to 4ng/ml - treatment failure will be defined as at least 50% rise above the nadir value and also above 4ng/ml.


  7. Progression-free survival [ Time Frame: 1:Not applicable ]
    Incidence of mortality without a progression event

  8. Lymph node progression [ Time Frame: 1:Not applicable ]
    Incidence and severity of lymph node events

  9. Distant metastases [ Time Frame: 1:Not applicable ]
    Incidence and severity of distant metastatic events

  10. Treatment for progression [ Time Frame: 1:Not applicable ]
    Identifying the treatments used in second line treatment

  11. Disease-specific survival [ Time Frame: 1:Not applicable ]
    Mortality attributed to Prostate Cancer

  12. Non-prostate cancer death [ Time Frame: 1:Not applicable ]
    Mortality not attributed to Prostate Cancer

  13. Metabolic effects [ Time Frame: 1:Not applicable ]
    Incidence and severity of effects on metabolic systems



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Participants must fulfil both of the criteria in Section 1 or at least one criterion in Section 2 or at least one criterion in Section 3 of the protocol. Additionally, all patients must fulfil the criteria in Section 4.

  1. High-Risk Newly-Diagnosed Non-Metastatic Node-Negative 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; exemption can be sought in advance of consent, after discussion with CTU)

    OR

  2. Newly-Diagnosed Metastatic Or Node-Positive Disease

    At least one of:

    •Stage Tany N+ M0

    •Stage Tany Nany M+

    OR

  3. 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

    •N+

    •M+

    AND

  4. For All Patients
  1. Histologically confirmed prostate adenocarcinoma
  2. Intention to treat with long-term androgen deprivation therapy
  3. Treating clinician and patient should have decided if docetaxel is to be part of the standard-of-care prior to randomisation
  4. Fit for all protocol treatment1 and follow-up, WHO performance status 0-22
  5. Have completed the appropriate investigations prior to randomisation
  6. Adequate haematological function: neutrophil count >1.5x109/l and platelets >100x109/l
  7. Adequate renal function, defined as GFR >30ml/min/1.73m2
  8. Serum potassium ≥3.5mmol/L
  9. Written informed consent
  10. Willing and expected to comply with follow-up schedule
  11. Using effective contraceptive method if applicable
  1. Medical contraindications to the trial medications are given in Section 6
  2. For WHO performance status definitions see Appendix A

Exclusion Criteria

Patients must not fulfil any of the criteria, below.

  1. Prior systemic therapy for locally-advanced or metastatic prostate cancer except as listed above
  2. Metastatic brain disease or leptomeningeal disease
  3. 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
  4. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
  5. Any surgery (e.g. TURP) performed within the past 4 weeks
  6. Patients with significant cardiovascular disease such that, in the investigator's opinion, the patient is unfit for any of the study treatments. This might include:

    •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 (NYHA II-IV)3

    •Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 6 months prior to randomisation

    •Patients with uncontrolled hypertension defined as systolic BP greater or equal than 160mmHg or diastolic BP greater or equal than 95mmHg5

  7. Prior chemotherapy for prostate cancer (excluding patients receiving docetaxel as part of the new SOC)
  8. Prior exposure to long-term hormone therapy before randomisation
  9. Prior exposure to systemic treatment for prostate cancer (excluding hormone therapy) e.g. abiraterone and enzalutamide.

3 NYHA classifications can be found in Appendix A

5 Based on representative values, as judged by the investigator

For Randomisation to the "Metformin Comparison"

Patients with known diabetes mellitus are not eligible for randomisation to the "metformin comparison". All non-diabetic patients require an HbA1c to be performed prior to randomisation (ideal timeline: within 8 weeks prior to randomisation), to confirm their non-diabetic status.

In addition, an assessment of renal function is required to determine glomerular filtration rate (GFR). The method used to determine glomerular filtration rate may vary according local practice. Equations that either estimate glomerular filtration rate (eGFR) or creatinine clearance (CrCl) may be used and the same threshold value applies. In summary, additional inclusion criteria specifically for the "metformin comparison" are

•HbA1c <48mmol/mol (equivalent to <6.5%)*

•Adequate renal function, defined as GFR ≥45ml/min/1.73m2

  • No history of lactic acidosis or pre-disposing conditions
  • Not current or previous treatment with metformin
  • No contra-indications to metformin

    • Except Switzerland, please refer to SAKK appendix for local guidance

Note that if the patient is known to be diabetic or the patient is found to have diabetes mellitus (i.e. HbA1c is 6.5% or higher) following screening, the patient is only eligible for randomisation if they meet all of the selection criteria for the "transdermal oestradiol comparison" (randomisation between Arms A and L only) All patients with abnormal baseline HbA1c (i.e. 6.0% or higher) should be informed and referred to their GP for further management.

Where possible, the screening bloods, including HbA1c, should be performed prior to commencing SOC docetaxel. This is to reduce the likelihood of corticosteroid-related hyperglycaemia impacting on eligibility for the "metformin comparison".

For Randomisation To The "Transdermal Oestradiol Comparison"

Patients who have any of the following are not eligible for the "transdermal oestradiol comparison":

•>8 weeks of anti-androgen use

•>1 dose of monthly or 4 weekly LHRH agonist/antagonist

  • Prior LHRH agonist injection with a stated duration of effect greater than 1 month •>12 weeks since first dose of any hormone therapy
  • Bilateral orchidectomy
  • Cyproterone acetate started prior to randomisation
  • Known porphyria
  • Any history of deep vein thrombosis or pulmonary embolism confirmed radiologically
  • Known thrombophilic disorder (e.g. Protein C, protein S, antithrombin deficiency)

Note that patients unsuitable for the "transdermal oestradiol comparison" will only be eligible for randomisation if they meet all of the selection criteria for the "metformin comparison" and therefore may be allocated to control (arm A) or metformin (arm K) only.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268476


Contacts
Contact: STAMPEDE Trial Team +44 (0)20 7670 4700 mrcctu.stampede@ucl.ac.uk

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Locations
Switzerland
Kantonsspital Graubuenden Recruiting
Chur, Graubunden, Switzerland, CH-7000
Lausanne Centre Hospitalier Universitaire Recruiting
Lausanne, Vaud, Switzerland, CH-1011
Winterthur Hospital Recruiting
Winterthur, Zurich, Switzerland, CH-8401
Hirslanden Klinik Aarau Recruiting
Aarau, Switzerland, CH-5000
Universitaetsspital-Basel Recruiting
Basel, Switzerland, CH-4031
Inselspital Bern Recruiting
Berne, Switzerland, CH-3010 Be
Liestal Hospital Recruiting
Liestal, Switzerland, CH-4410
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, CH-9007
UniversitaetsSpital Zuerich Recruiting
Zurich, Switzerland, CH-8091
City Hospital Triemli Recruiting
Zurich, Switzerland
United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital Recruiting
Reading, Berkshire, United Kingdom, RG1 5AN
Royal Bolton Hospital Recruiting
Farnworth, Bolton, United Kingdom, BL4 0JR
Wycombe General Hospital Recruiting
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
Addenbrooke's Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Broomfield Hospital Recruiting
Broomfield, Chelmsford, United Kingdom, CM1 7ET
Countess of Chester Hospital Recruiting
Chester, Chesire, United Kingdom, CH2 1UL
James Cook University Hospital Recruiting
Middlesbrough, County Durham, United Kingdom, TS4 3BW
Cumberland Infirmary Recruiting
Carlisle, Cumbria, United Kingdom, CA2 7HY
North Devon District Hospital Recruiting
Barnstaple, Devon, United Kingdom, EX31 4JB
Royal Devon and Exeter Hospital Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Royal Bournemouth Hospital Recruiting
Bournemouth, Dorset, United Kingdom, BH7 7DW
Dorset County Hospital Recruiting
Dorchester, Dorset, United Kingdom, DT1 2JY
Poole Hospital Recruiting
Poole, Dorset, United Kingdom, BH15 2JB
Castle Hill Hospital Recruiting
Cottingham, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
Eastbourne District General Hospital Recruiting
Eastbourne, East Sussex, United Kingdom, BN21 2UD
Conquest Hospital Recruiting
Saint Leonards-on-Sea, East Sussex, United Kingdom, TN37 7PT
William Harvey Hospital Recruiting
Ashford, England, United Kingdom, TN24 0LZ
Contact: Contact Person    44-1233-633-331      
Stoke Mandeville Hospital Recruiting
Aylesbury, England, United Kingdom, HP21 8AL
Basingstoke and North Hampshire NHS Foundation Trust Recruiting
Basingstoke, England, United Kingdom, RG24 9NA
City Hospital (Birmingham) Recruiting
Birmingham, England, United Kingdom, B18 7QH
Sussex Cancer Centre at Royal Sussex County Hospital Recruiting
Brighton, England, United Kingdom, BN2 5BE
Burnley General Hospital Recruiting
Burnley, England, United Kingdom, BB10 2PQ
Queen's Hospital Recruiting
Burton-upon-Trent, England, United Kingdom, DE13 0RB
West Suffolk Hospital Recruiting
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Mid Cheshire Hospitals Trust- Leighton Hopsital Recruiting
Crewe, England, United Kingdom, CW1 4QJ
Darlington Memorial Recruiting
Darlington, England, United Kingdom, DL3 6HX
Derbyshire Royal Infirmary Recruiting
Derby, England, United Kingdom, DE22 3NE
Doncaster Royal Infirmary Recruiting
Doncaster, England, United Kingdom, DN2 5LT
Russells Hall Hospital Recruiting
Dudley, England, United Kingdom, DY1 2HQ
University Hospital of North Durham Active, not recruiting
Durham, England, United Kingdom, DH1 5TW
Gloucestershire Royal Hospital Recruiting
Gloucester, England, United Kingdom, GL1 3NN
Hereford County Hospital Recruiting
Hereford, England, United Kingdom, HR1 2ER
Kidderminster Hospital Recruiting
Kidderminster, England, United Kingdom, DY11 6RJ
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Glenfield Hospital Recruiting
Leicester, England, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, England, United Kingdom, L7 8XP
University Hospital Aintree Recruiting
Liverpool, England, United Kingdom, L9 7AL
Helen Rollason Cancer Care Centre at North Middlesex Hospital Recruiting
London, England, United Kingdom, N18 1QX
Guy's Hospital Recruiting
London, England, United Kingdom, SE1 9RT
St. Mary's Hospital Recruiting
London, England, United Kingdom, W2 1NY
UCL Cancer Institute Recruiting
London, England, United Kingdom, WC1E 6DD
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Withington Hospital Recruiting
Manchester, England, United Kingdom, M20 8LR
Royal Shrewsbury Hospital Recruiting
Shrewsbury, England, United Kingdom, SY3 8XQ
Stepping Hill Hospital Recruiting
Stockport, England, United Kingdom, SK2 7JE
Sunderland Royal Hospital Recruiting
Sunderland, England, United Kingdom, SR4 7TP
Torbay Hospital Recruiting
Torquay, England, United Kingdom, TQ2 7AA
Warrington Hospital NHS Trust Recruiting
Warrington, England, United Kingdom, WA5 1QG
West Cumberland Hospital Recruiting
Whitehaven, England, United Kingdom, CA28 8JG
Royal Albert Edward Infirmary Recruiting
Wigan, England, United Kingdom, WN1 2NN
Worcester Royal Hospital Recruiting
Worcester, England, United Kingdom, WR5 1DD
Worthing Hospital Recruiting
Worthing, England, United Kingdom, BN11 2DH
Princess Alexandra Hospital Recruiting
Harlow, Essex, United Kingdom, CM20 1QX
Queen's Hospital Recruiting
Romford, Essex, United Kingdom, RM7 0AG
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, Essex, United Kingdom, SS0 0RY
South West Wales Cancer Institute At Singleton Hospital Recruiting
Swansea, Glamorgan, United Kingdom, SA2 8QA
Cheltenham General Hospital Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
St. Bartholomews Hospital Recruiting
London, Greater London, United Kingdom, EC1A 7BE
Queen Elizabeth Hospital - Woolwich Recruiting
London, Greater London, United Kingdom, SE18 4QH
St. George's Hospital Recruiting
London, Greater London, United Kingdom, SW17 0QT
Charing Cross Hospital Recruiting
London, Greater London, United Kingdom, W6 8RF
Christie Hospital Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Royal Oldham Hospital Recruiting
Oldham, Greater Manchester, United Kingdom, OL1 2JH
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, S016 6YD
Lister Hospital Recruiting
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Raigmore Hospital Recruiting
Inverness, Highland, United Kingdom, IV2 3UJ
St. Mary's Hospital Recruiting
Newport, Isle Of Wight, United Kingdom, PO30 5TG
Airedale General Hospital Recruiting
Steeton, Keighley, United Kingdom, BD20 6TD
Kent and Canterbury Hospital Recruiting
Canterbury, Kent, United Kingdom, CT1 3NG
Mid Kent Oncology Centre at Maidstone Hospital Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Queen Elizabeth The Queen Mother Hospital Recruiting
Margate, Kent, United Kingdom, CT9 4AN
Beatson Institute for Cancer Research - Glasgow Recruiting
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Rosemere Cancer Centre at Royal Preston Hospital Recruiting
Preston, Lancashire, United Kingdom, PR2 4QF
Southport and Formby District General Hospital Recruiting
Southport, Merseyside, United Kingdom, PR8 6PN
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Freeman Hospital Recruiting
Newcastle, Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Scarborough General Hospital Recruiting
Scarborough, North Yorkshire, United Kingdom, YO12 6QL
Centre for Cancer Research and Cell Biology at Queen's University Belfast Recruiting
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Nottingham City Hospital Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
King's Mill Hospital Recruiting
Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
Churchill Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Queen Alexandra Hospital Recruiting
Cosham, Portsmouth, United Kingdom, P06 3LY
Ayr Hospital Recruiting
Ayr, Scotland, United Kingdom, KA6 6DX
Royal United Hospital Recruiting
Bath, Somerset, United Kingdom, BA1 3NG
Bristol Haematology and Oncology Centre Recruiting
Bristol, Somerset, United Kingdom, BS2 8ED
Musgrove Park Hospital Recruiting
Taunton, Somerset, United Kingdom, TA1 5DA
Weston General Hospital Recruiting
Weston Super Mare, Somerset, United Kingdom, BS23 4TQ
Yeovil District Hospital Recruiting
Yeovil, Somerset, United Kingdom, BA21 4AT
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Royal Stoke University Hospital Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Ipswich Hospital Recruiting
Ipswich, Suffolk, United Kingdom, IP4 5PD
St. Luke's Cancer Centre at Royal Surrey County Hospital Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Royal Marsden - Sutton Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Northern Centre for Cancer Treatment at Newcastle General Hospital Recruiting
Newcastle-Upon-Tyne, Tyne & Wear, United Kingdom, NE4 6BE
South Tyneside District Hospital Recruiting
South Shields, Tyne & Wear, United Kingdom, NE34 0PL
Bronglais General Hospital Recruiting
Aberystwyth, Wales, United Kingdom, SY23 1ER
Velindre Cancer Center at Velindre Hospital Recruiting
Cardiff, Wales, United Kingdom, CF14 2TL
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Good Hope Hospital Recruiting
Sutton Coldfield, West Midlands, United Kingdom, B75 7RR
Bradford Royal Infirmary Recruiting
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Huddersfield Royal Infirmary Recruiting
Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
Great Western Hospital Recruiting
Swindon, Wiltshire, United Kingdom, SN3 6BB
Clatterbridge Centre for Oncology Recruiting
Bebington, Wirral, United Kingdom, CH63 4JY
Barnet General Hospital Recruiting
Barnet, United Kingdom, EN5 3DJ
Colchester General Hospital Recruiting
Colchester, United Kingdom, CO4 5JL
Forth Valley Hospital Recruiting
Larbert, United Kingdom, FK5 4WR
Lincoln Hospital Recruiting
Lincoln, United Kingdom, LN2 5QY
North Tees Hospital Recruiting
Stockton-on-Tees, United Kingdom, TS19 8PE
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Nicholas D. James, MD University Hospital Birmingham

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
James 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.

Responsible Party: Medical Research Council
ClinicalTrials.gov Identifier: NCT00268476     History of Changes
Other Study ID Numbers: CDR0000455008
MRC-STAMPEDE ( Other Identifier: MRC )
EU-205102 ( Other Identifier: EU )
PR08 ( Other Identifier: MRC CTU at UCL )
ISRCTN78818544 ( Registry Identifier: ISRCTN )
2004-000193-31 ( EudraCT Number )
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical Research Council:
Stage III Prostate Cancer
Stage IV Prostate Cancer
Recurrent Prostate Cancer
Adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Metformin
Docetaxel
Prednisolone
Methylprednisolone Hemisuccinate
Estradiol
Polyestradiol phosphate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Prednisolone acetate
Methylprednisolone acetate
Celecoxib
Androgens
Zoledronic acid
Diphosphonates
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents