Clinical trial NCT00268476: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
Official title: STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Stage III Prostate Cancer
Stage IV Prostate Cancer
Recurrent Prostate Cancer
Adenocarcinoma of the prostate
Lead sponsor: Medical Research Council
Sponsor class: OTHER_GOV
First posted: 2005-12-22
Enrollment: 11992
Sex: MALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-arm Multi-Stage
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria Participants must fulfil all the criteria in one of the following three categories. Additionally, all patients must fulfil the criteria in Section 4.

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
4. General Inclusion Criteria Required For All Participants

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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

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1. Medical contraindications to the trial medications are given in Section 6
2. For WHO performance status definitions see Appendix A

5. General 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

In addition to the general inclusion and exclusion criteria, the following comparison-specific eligibility criteria apply.

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.

In addition to the general inclusion and general exclusion criteria the following comparison-specific inclusion criteria must be met to be eligible for randomisation to the "metformin comparison":

• 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"

In addition to the general inclusion and exclusion criteria, participants fulfilling all of the following are eligible for the "transdermal oestradiol comparison":

• ≤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

Primary outcomes:
measure: Overall survival
timeFrame: 1:Not applicable
Secondary outcomes:
measure: Failure-free survival
timeFrame: 1:Not applicable
measure: Cost effectiveness by EuroQol
timeFrame: 1:Not applicable
measure: Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item
timeFrame: 1:Not applicable
measure: Number of participants with treatment-related side effects as assessed by CTCAE v4.0
timeFrame: 1:Not applicable
measure: Skeletal related events
timeFrame: 1:Not applicable
measure: Biochemical failure
timeFrame: 1:Not applicable
measure: Progression-free survival
timeFrame: 1:Not applicable
measure: Lymph node progression
timeFrame: 1:Not applicable
measure: Distant metastases
timeFrame: 1:Not applicable
measure: Treatment for progression
timeFrame: 1:Not applicable
measure: Disease-specific survival
timeFrame: 1:Not applicable
measure: Non-prostate cancer death
timeFrame: 1:Not applicable
measure: Metabolic effects
timeFrame: 1:Not applicable
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
state: Graubunden
city: Lausanne
country: Switzerland
facility: Lausanne Centre Hospitalier Universitaire
state: Vaud
city: Winterthur
country: Switzerland
facility: Winterthur Hospital
state: Zurich
city: Aarau
country: Switzerland
facility: Hirslanden Klinik Aarau
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Berne
country: Switzerland
facility: Inselspital Bern
city: Liestal
country: Switzerland
facility: Liestal Hospital
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich
city: Zurich
country: Switzerland
facility: City Hospital Triemli
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: Berkshire
city: Farnworth
country: United Kingdom
facility: Royal Bolton Hospital
state: Bolton
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
state: Buckinghamshire
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Broomfield
country: United Kingdom
facility: Broomfield Hospital
state: Chelmsford
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
state: Chesire
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: County Durham
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
state: Cumbria
city: Barnstaple
country: United Kingdom
facility: North Devon District Hospital
state: Devon
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: Devon
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: Dorset
city: Poole
country: United Kingdom
facility: Poole Hospital
state: Dorset
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: East Riding Of Yorkshire
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: East Sussex
city: Saint Leonards-on-Sea
country: United Kingdom
facility: Conquest Hospital
state: East Sussex
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
state: England
city: Aylesbury
country: United Kingdom
facility: Stoke Mandeville Hospital
state: England
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire NHS Foundation Trust
state: England
city: Birmingham
country: United Kingdom
facility: City Hospital (Birmingham)
state: England
city: Brighton
country: United Kingdom
facility: Sussex Cancer Centre at Royal Sussex County Hospital
state: England
city: Burnley
country: United Kingdom
facility: Burnley General Hospital
state: England
city: Burton-upon-Trent
country: United Kingdom
facility: Queen's Hospital
state: England
city: Bury St. Edmunds
country: United Kingdom
facility: West Suffolk Hospital
state: England
city: Crewe
country: United Kingdom
facility: Mid Cheshire Hospitals Trust- Leighton Hopsital
state: England
city: Darlington
country: United Kingdom
facility: Darlington Memorial
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: England
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: England
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
state: England
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
state: England
city: Hereford
country: United Kingdom
facility: Hereford County Hospital
state: England
city: Kidderminster
country: United Kingdom
facility: Kidderminster Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: England
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
state: England
city: London
country: United Kingdom
facility: Helen Rollason Cancer Care Centre at North Middlesex Hospital
state: England
city: London
country: United Kingdom
facility: Guy's Hospital
state: England
city: London
country: United Kingdom
facility: St. Mary's Hospital
state: England
city: London
country: United Kingdom
facility: UCL Cancer Institute
state: England
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
city: Manchester
country: United Kingdom
facility: Withington Hospital
state: England
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: England
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: England
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
state: England
city: Torquay
country: United Kingdom
facility: Torbay Hospital
state: England
city: Warrington
country: United Kingdom
facility: Warrington Hospital NHS Trust
state: England
city: Whitehaven
country: United Kingdom
facility: West Cumberland Hospital
state: England
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
state: England
city: Worcester
country: United Kingdom
facility: Worcester Royal Hospital
state: England
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: England
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
state: Essex
city: Romford
country: United Kingdom
facility: Queen's Hospital
state: Essex
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: Essex
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Institute At Singleton Hospital
state: Glamorgan
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: Gloucestershire
city: London
country: United Kingdom
facility: St. Bartholomews Hospital
state: Greater London
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital - Woolwich
state: Greater London
city: London
country: United Kingdom
facility: St. George's Hospital
state: Greater London
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: Greater London
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: Greater Manchester
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Hertfordshire
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Highland
city: Newport
country: United Kingdom
facility: St. Mary's Hospital
state: Isle Of Wight
city: Steeton
country: United Kingdom
facility: Airedale General Hospital
state: Keighley
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: Kent
city: Maidstone
country: United Kingdom
facility: Mid Kent Oncology Centre at Maidstone Hospital
state: Kent
city: Margate
country: United Kingdom
facility: Queen Elizabeth The Queen Mother Hospital
state: Kent
city: Glasgow
country: United Kingdom
facility: Beatson Institute for Cancer Research - Glasgow
state: Lanarkshire
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre at Royal Preston Hospital
state: Lancashire
city: Southport
country: United Kingdom
facility: Southport and Formby District General Hospital
state: Merseyside
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: Middlesex
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre at Western General Hospital
state: Midlothian
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
state: Newcastle-upon-Tyne
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: North Yorkshire
city: Belfast
country: United Kingdom
facility: Centre for Cancer Research and Cell Biology at Queen's University Belfast
state: Northern Ireland
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: Nottinghamshire
city: Sutton-in-Ashfield
country: United Kingdom
facility: King's Mill Hospital
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Cosham
country: United Kingdom
facility: Queen Alexandra Hospital
state: Portsmouth
city: Ayr
country: United Kingdom
facility: Ayr Hospital
state: Scotland
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: Somerset
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: Somerset
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
state: Somerset
city: Weston Super Mare
country: United Kingdom
facility: Weston General Hospital
state: Somerset
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: Somerset
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: South Yorkshire
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: Suffolk
city: Guildford
country: United Kingdom
facility: St. Luke's Cancer Centre at Royal Surrey County Hospital
state: Surrey
city: Sutton
country: United Kingdom
facility: Royal Marsden - Sutton
state: Surrey
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment at Newcastle General Hospital
state: Tyne & Wear
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital
state: Tyne & Wear
city: Aberystwyth
country: United Kingdom
facility: Bronglais General Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
state: West Midlands
city: Sutton Coldfield
country: United Kingdom
facility: Good Hope Hospital
state: West Midlands
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: West Yorkshire
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: West Yorkshire
city: Swindon
country: United Kingdom
facility: Great Western Hospital
state: Wiltshire
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: Wirral
city: Barnet
country: United Kingdom
facility: Barnet General Hospital
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
city: Larbert
country: United Kingdom
facility: Forth Valley Hospital
city: Lincoln
country: United Kingdom
facility: Lincoln Hospital
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Institute of Cancer Research, United Kingdom
name: Nicholas D. James, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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