Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
NCT ID: NCT00268476
Last Updated: 2023-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2/PHASE3
Total Enrollment
11992 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-07-08
Study Completion Date
2030-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Prostate Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Multi-arm Multi-Stage
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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)\[Control\]
Group Type
ACTIVE_COMPARATOR
ADT
Intervention Type
DRUG
Arm B: Zoledronic Acid
(ADT + zoledronic acid) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
ADT
Intervention Type
DRUG
Zoledronic Acid
Intervention Type
DRUG
Arm C: Docetaxel
(ADT + docetaxel + prednisolone) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
Docetaxel
Intervention Type
DRUG
Prednisolone
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Arm D: Celecoxib
(ADT + celecoxib) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
Celecoxib
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Arm E: Zoledronic Acid & Docetaxel
(ADT + zoledronic acid + docetaxel + prednisolone) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
Docetaxel
Intervention Type
DRUG
Prednisolone
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Zoledronic Acid
Intervention Type
DRUG
Arm F: Zoledronic Acid & Celecoxib
(ADT + zoledronic acid + celecoxib) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
Celecoxib
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Zoledronic Acid
Intervention Type
DRUG
Arm G: Abiraterone
(ADT + abiraterone acetate + prednisolone) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
Prednisolone
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Abiraterone
Intervention Type
DRUG
Arm H: M1 RT
(ADT + radiotherapy to the prostate) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
ADT
Intervention Type
DRUG
Radiotherapy to the prostate
Intervention Type
RADIATION
Arm J: Abiraterone * Enzalutamide
(ADT + abiraterone + enzalutamide + Prednisolone) NO LONGER RECRUITING
Group Type
EXPERIMENTAL
Prednisolone
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Abiraterone
Intervention Type
DRUG
Enzalutamide
Intervention Type
DRUG
Arm K: Metformin
(ADT + Metformin) RECRUITING IN SELECTED SITES
Group Type
EXPERIMENTAL
ADT
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Arm L: tE2
(Transdermal oestradiol) RECRUITING
Group Type
EXPERIMENTAL
Transdermal Oestradiol
Intervention Type
DRUG
Interventions
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Celecoxib
Intervention Type
DRUG
Docetaxel
Intervention Type
DRUG
Prednisolone
Intervention Type
DRUG
ADT
Intervention Type
DRUG
Zoledronic Acid
Intervention Type
DRUG
Abiraterone
Intervention Type
DRUG
Radiotherapy to the prostate
Intervention Type
RADIATION
Enzalutamide
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Transdermal Oestradiol
Intervention Type
DRUG
Other Intervention Names
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Celebrex
Taxotere
Prednisone
Androgen Deprivation Therapy
Zometa
Zytiga
RT
Xtandi
Metformin Hydrochloride
Progynova TS
Eligibility Criteria
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Inclusion Criteria
1. 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)
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
<!-- -->
1. Histologically confirmed prostate adenocarcinoma
2. Intention to treat with long-term androgen deprivation therapy
3. Fit for all protocol treatment and follow up, WHO performance status 0-2
4. Have completed the appropriate investigations prior to randomisation
5. Adequate haematological function: neutrophil count ≥1.5x109/l and platelets ≥100x109/l
6. Adequate renal function, defined as GFR ≥30ml/min/1.73m2
7. Written informed consent
8. Willing and expected to comply with follow up schedule
9. 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
• HbA1c \<48mmol/mol (equivalent to \<6.5%) (1)
• Adequate renal function, defined as GFR ≥45ml/min/1.73m (except for Switzerland (2))
• No history of lactic acidosis or pre-disposing conditions
* Not current or previous treatment with metformin
* No contra-indications to metformin
* No current or previous medication for treatment of diabetes
* Willingness to join the metabolic sub study
The method used to determine glomerular filtration rate may vary according to local practice.
Equations that either estimate glomerular filtration rate (eGFR) or creatinine clearance (CrCl) may be used and the same threshold value applies. Where possible, HbA1c should be performed prior to commencing SOC docetaxel to reduce the likelihood of corticosteroid-related hyperglycaemia impacting on eligibility. All participants with abnormal baseline HbA1c (i.e. 6.5% or higher) should be informed and referred to their GP for further management.
(2) Except Switzerland, please refer to SAKK appendix for local guidance
For Randomisation To The "Transdermal Oestradiol Comparison"
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)
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
<!-- -->
1. Histologically confirmed prostate adenocarcinoma
2. Intention to treat with long-term androgen deprivation therapy
3. Fit for all protocol treatment and follow up, WHO performance status 0-2
4. Have completed the appropriate investigations prior to randomisation
5. Adequate haematological function: neutrophil count ≥1.5x109/l and platelets ≥100x109/l
6. Adequate renal function, defined as GFR ≥30ml/min/1.73m2
7. Written informed consent
8. Willing and expected to comply with follow up schedule
9. 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
• HbA1c \<48mmol/mol (equivalent to \<6.5%) (1)
• Adequate renal function, defined as GFR ≥45ml/min/1.73m (except for Switzerland (2))
• No history of lactic acidosis or pre-disposing conditions
* Not current or previous treatment with metformin
* No contra-indications to metformin
* No current or previous medication for treatment of diabetes
* Willingness to join the metabolic sub study
The method used to determine glomerular filtration rate may vary according to local practice.
Equations that either estimate glomerular filtration rate (eGFR) or creatinine clearance (CrCl) may be used and the same threshold value applies. Where possible, HbA1c should be performed prior to commencing SOC docetaxel to reduce the likelihood of corticosteroid-related hyperglycaemia impacting on eligibility. All participants with abnormal baseline HbA1c (i.e. 6.5% or higher) should be informed and referred to their GP for further management.
(2) Except Switzerland, please refer to SAKK appendix for local guidance
For Randomisation To The "Transdermal Oestradiol Comparison"
Exclusion Criteria
Patients must not fulfil any of the criteria below:
1. Prior systemic therapy for locally-advanced or metastatic prostate cancer (1) (except as listed in the protocol section 4.3)
2. 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)
3. Metastatic brain disease or leptomeningeal disease
4. 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.
5. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
6. Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment
7. 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
* Any other significant cardiovascular disease that in the investigator's opinion means the participant is unfit for any of the study treatments.
1. Excluding participants receiving docetaxel as part of SOC
2. NYHA classifications can be found in Appendix A
6\. Comparison-specific eligibility criteria
For Randomisation to the "Metformin Comparison"
Please note from protocol v20 only patients willing to participate in the metabolic sub study should be randomised to the metformin comparison. The sub study will be conducted in a limited number of sites, see section 4.7.4 for further information.
• ≤8 weeks of anti-androgen (AR-antagonists) use
• Maximum of 1 dose of monthly or 4-weekly LHRH agonist/antagonist
• No prior LHRH agonist injection with a stated duration of effect greater than 1 month
• ≤12 weeks since first dose of any hormone therapy
• Not had a bilateral orchidectomy
• No use of cyproterone acetate (36) prior to randomisation
• No known porphyria
* No known history of deep vein thrombosis or pulmonary embolism confirmed radiologically
* No known thrombophilic disorder (e.g. Protein C, Protein S, antithrombin deficiency)
* Not yet started SOC abiraterone, enzalutamide or apalutamide
1. Prior systemic therapy for locally-advanced or metastatic prostate cancer (1) (except as listed in the protocol section 4.3)
2. 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)
3. Metastatic brain disease or leptomeningeal disease
4. 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.
5. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
6. Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment
7. 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
* Any other significant cardiovascular disease that in the investigator's opinion means the participant is unfit for any of the study treatments.
1. Excluding participants receiving docetaxel as part of SOC
2. NYHA classifications can be found in Appendix A
6\. Comparison-specific eligibility criteria
For Randomisation to the "Metformin Comparison"
Please note from protocol v20 only patients willing to participate in the metabolic sub study should be randomised to the metformin comparison. The sub study will be conducted in a limited number of sites, see section 4.7.4 for further information.
• ≤8 weeks of anti-androgen (AR-antagonists) use
• Maximum of 1 dose of monthly or 4-weekly LHRH agonist/antagonist
• No prior LHRH agonist injection with a stated duration of effect greater than 1 month
• ≤12 weeks since first dose of any hormone therapy
• Not had a bilateral orchidectomy
• No use of cyproterone acetate (36) prior to randomisation
• No known porphyria
* No known history of deep vein thrombosis or pulmonary embolism confirmed radiologically
* No known thrombophilic disorder (e.g. Protein C, Protein S, antithrombin deficiency)
* Not yet started SOC abiraterone, enzalutamide or apalutamide
Maximum Eligible Age
120 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Medical Research Council
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Medical Research Council
Medical Research Council
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Nicholas D. James, MD
Role: STUDY_CHAIR
Institute of Cancer Research, United Kingdom
Locations
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Lausanne Centre Hospitalier Universitaire
Lausanne, Canton of Vaud, Switzerland
Site Status
Winterthur Hospital
Winterthur, Canton of Zurich, Switzerland
Site Status
Kantonsspital Graubuenden
Chur, Kanton Graubünden, Switzerland
Site Status
Hirslanden Klinik Aarau
Aarau, , Switzerland
Site Status
Universitaetsspital-Basel
Basel, , Switzerland
Site Status
Inselspital Bern
Bern, , Switzerland
Site Status
Liestal Hospital
Liestal, , Switzerland
Site Status
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Site Status
UniversitaetsSpital Zuerich
Zurich, , Switzerland
Site Status
City Hospital Triemli
Zurich, , Switzerland
Site Status
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, Berkshire, United Kingdom
Site Status
Royal Bolton Hospital
Farnworth, Bolton, United Kingdom
Site Status
Wycombe General Hospital
High Wycombe, Buckinghamshire, United Kingdom
Site Status
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Site Status
Broomfield Hospital
Broomfield, Chelmsford, United Kingdom
Site Status
Countess of Chester Hospital
Chester, Chesire, United Kingdom
Site Status
James Cook University Hospital
Middlesbrough, County Durham, United Kingdom
Site Status
Cumberland Infirmary
Carlisle, Cumbria, United Kingdom
Site Status
North Devon District Hospital
Barnstaple, Devon, United Kingdom
Site Status
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom
Site Status
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Site Status
Dorset County Hospital
Dorchester, Dorset, United Kingdom
Site Status
Poole Hospital
Poole, Dorset, United Kingdom
Site Status
Castle Hill Hospital
Cottingham, East Riding Of Yorkshire, United Kingdom
Site Status
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
Site Status
Conquest Hospital
Saint Leonards-on-Sea, East Sussex, United Kingdom
Site Status
William Harvey Hospital
Ashford, England, United Kingdom
Site Status
Stoke Mandeville Hospital
Aylesbury, England, United Kingdom
Site Status
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Site Status
City Hospital (Birmingham)
Birmingham, England, United Kingdom
Site Status
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Site Status
Burnley General Hospital
Burnley, England, United Kingdom
Site Status
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Site Status
West Suffolk Hospital
Bury St Edmunds, England, United Kingdom
Site Status
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, United Kingdom
Site Status
Darlington Memorial
Darlington, England, United Kingdom
Site Status
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Site Status
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Site Status
Russells Hall Hospital
Dudley, England, United Kingdom
Site Status
University Hospital of North Durham
Durham, England, United Kingdom
Site Status
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Site Status
Hereford County Hospital
Hereford, England, United Kingdom
Site Status
Kidderminster Hospital
Kidderminster, England, United Kingdom
Site Status
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Site Status
Glenfield Hospital
Leicester, England, United Kingdom
Site Status
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Site Status
University Hospital Aintree
Liverpool, England, United Kingdom
Site Status
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, United Kingdom
Site Status
Guy's Hospital
London, England, United Kingdom
Site Status
St. Mary's Hospital
London, England, United Kingdom
Site Status
UCL Cancer Institute
London, England, United Kingdom
Site Status
University College of London Hospitals
London, England, United Kingdom
Site Status
Withington Hospital
Manchester, England, United Kingdom
Site Status
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Site Status
Stepping Hill Hospital
Stockport, England, United Kingdom
Site Status
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Site Status
Torbay Hospital
Torquay, England, United Kingdom
Site Status
Warrington Hospital NHS Trust
Warrington, England, United Kingdom
Site Status
West Cumberland Hospital
Whitehaven, England, United Kingdom
Site Status
Royal Albert Edward Infirmary
Wigan, England, United Kingdom
Site Status
Worcester Royal Hospital
Worcester, England, United Kingdom
Site Status
Worthing Hospital
Worthing, England, United Kingdom
Site Status
Princess Alexandra Hospital
Harlow, Essex, United Kingdom
Site Status
Queen's Hospital
Romford, Essex, United Kingdom
Site Status
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, Essex, United Kingdom
Site Status
South West Wales Cancer Institute At Singleton Hospital
Swansea, Glamorgan, United Kingdom
Site Status
Cheltenham General Hospital
Cheltenham, Gloucestershire, United Kingdom
Site Status
St. Bartholomews Hospital
London, Greater London, United Kingdom
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Queen Elizabeth Hospital - Woolwich
London, Greater London, United Kingdom
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St. George's Hospital
London, Greater London, United Kingdom
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Charing Cross Hospital
London, Greater London, United Kingdom
Site Status
Christie Hospital
Manchester, Greater Manchester, United Kingdom
Site Status
Royal Oldham Hospital
Oldham, Greater Manchester, United Kingdom
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Southampton General Hospital
Southampton, Hampshire, United Kingdom
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Lister Hospital
Stevenage, Hertfordshire, United Kingdom
Site Status
Raigmore Hospital
Inverness, Highland, United Kingdom
Site Status
St. Mary's Hospital
Newport, Isle Of Wight, United Kingdom
Site Status
Airedale General Hospital
Steeton, Keighley, United Kingdom
Site Status
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom
Site Status
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, Kent, United Kingdom
Site Status
Queen Elizabeth The Queen Mother Hospital
Margate, Kent, United Kingdom
Site Status
Beatson Institute for Cancer Research - Glasgow
Glasgow, Lanarkshire, United Kingdom
Site Status
Rosemere Cancer Centre at Royal Preston Hospital
Preston, Lancashire, United Kingdom
Site Status
Southport and Formby District General Hospital
Southport, Merseyside, United Kingdom
Site Status
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, Middlesex, United Kingdom
Site Status
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Midlothian, United Kingdom
Site Status
Freeman Hospital
Newcastle, Newcastle-upon-Tyne, United Kingdom
Site Status
Scarborough General Hospital
Scarborough, North Yorkshire, United Kingdom
Site Status
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Site Status
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Site Status
King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, United Kingdom
Site Status
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Site Status
Queen Alexandra Hospital
Cosham, Portsmouth, United Kingdom
Site Status
Ayr Hospital
Ayr, Scotland, United Kingdom
Site Status
Royal United Hospital
Bath, Somerset, United Kingdom
Site Status
Bristol Haematology and Oncology Centre
Bristol, Somerset, United Kingdom
Site Status
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Site Status
Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom
Site Status
Yeovil District Hospital
Yeovil, Somerset, United Kingdom
Site Status
Cancer Research Centre at Weston Park Hospital
Sheffield, South Yorkshire, United Kingdom
Site Status
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Site Status
Ipswich Hospital
Ipswich, Suffolk, United Kingdom
Site Status
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Site Status
Royal Marsden - Sutton
Sutton, Surrey, United Kingdom
Site Status
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Site Status
South Tyneside District Hospital
South Shields, Tyne & Wear, United Kingdom
Site Status
Bronglais General Hospital
Aberystwyth, Wales, United Kingdom
Site Status
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Site Status
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, West Midlands, United Kingdom
Site Status
Good Hope Hospital
Sutton Coldfield, West Midlands, United Kingdom
Site Status
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
Site Status
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, United Kingdom
Site Status
Great Western Hospital
Swindon, Wiltshire, United Kingdom
Site Status
Clatterbridge Centre for Oncology
Bebington, Wirral, United Kingdom
Site Status
Barnet General Hospital
Barnet, , United Kingdom
Site Status
Colchester General Hospital
Colchester, , United Kingdom
Site Status
Forth Valley Hospital
Larbert, , United Kingdom
Site Status
Lincoln Hospital
Lincoln, , United Kingdom
Site Status
North Tees Hospital
Stockton-on-Tees, , United Kingdom
Site Status
New Cross Hospital
Wolverhampton, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Switzerland
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Sydes 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.
Reference Type
BACKGROUND
Parker 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.
Reference Type
BACKGROUND
Attard 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.
Reference Type
BACKGROUND
James 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.
Reference Type
BACKGROUND
James 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.
Reference Type
BACKGROUND
Gillessen 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.
Reference Type
BACKGROUND
Gilbert 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.
Reference Type
BACKGROUND
Parmar 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.
Reference Type
BACKGROUND
James 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.
Reference Type
RESULT
James 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.
Reference Type
RESULT
Vale 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.
Reference Type
RESULT
Mason 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.
Reference Type
RESULT
James 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.
Reference Type
RESULT
Sydes 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.
Reference Type
RESULT
Parker 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.
Reference Type
RESULT
Clarke 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.
Reference Type
RESULT
Gillessen 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.
Reference Type
DERIVED
Parker 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.
Reference Type
DERIVED
Gilbert 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.
Reference Type
DERIVED
Attard 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.
Reference Type
DERIVED
Grist 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.
Reference Type
DERIVED
Parker 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.
Reference Type
DERIVED
Attard 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.
Reference Type
DERIVED
Rush 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.
Reference Type
DERIVED
Ali 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.
Reference Type
DERIVED
Jakob 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.
Reference Type
DERIVED
Roy 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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Huang 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.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.stampedetrial.org/
Trial home page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRC-STAMPEDE
Identifier Type: OTHER
Identifier Source: secondary_id
EU-205102
Identifier Type: OTHER
Identifier Source: secondary_id
PR08
Identifier Type: OTHER
Identifier Source: secondary_id
ISRCTN78818544
Identifier Type: REGISTRY
Identifier Source: secondary_id
2004-000193-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDR0000455008
Identifier Type: -
Identifier Source: org_study_id
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A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06879041
RECRUITING
PHASE1
Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
NCT00005847
COMPLETED
PHASE2
Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
NCT01734681
WITHDRAWN
PHASE2
A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer
NCT01957436
ACTIVE_NOT_RECRUITING
PHASE3
S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
NCT00004001
COMPLETED
PHASE3
Impact of Atorvastatin on Prostate Cancer Progression During ADT
NCT04026230
RECRUITING
PHASE3
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
NCT03511196
ACTIVE_NOT_RECRUITING
EARLY_PHASE1
Chemotherapy in Treating Patients Who Have Metastatic Prostate Cancer
NCT00003343
COMPLETED
PHASE3
Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer
NCT03827473
TERMINATED
PHASE2
Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer
NCT01990196
ACTIVE_NOT_RECRUITING
PHASE2
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
NCT06592924
RECRUITING
PHASE3
Study of AZD0754 in Participants With Metastatic Prostate Cancer
NCT06267729
RECRUITING
PHASE1/PHASE2
Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC
NCT06193486
RECRUITING
PHASE1