NCT00268476 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2, PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2023-04-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

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  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 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
healthy Volunteers: false
maximum Age: 120 Years
sex: MALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Androgen Deprivation Therapy \[ADT\] (plus Radiotherapy for newly-diagnosed non-metastatic disease, plus or minus Docetaxel, plus or minus Abiraterone)\[Control\]
intervention Names
Drug: ADT
label
Arm A: Standard of Care
type
ACTIVE_COMPARATOR
description
(ADT + zoledronic acid) NO LONGER RECRUITING
intervention Names
Drug: ADT
Drug: Zoledronic Acid
label
Arm B: Zoledronic Acid
type
EXPERIMENTAL
description
(ADT + docetaxel + prednisolone) NO LONGER RECRUITING
intervention Names
Drug: Docetaxel
Drug: Prednisolone
Drug: ADT
label
Arm C: Docetaxel
type
EXPERIMENTAL
description
(ADT + celecoxib) NO LONGER RECRUITING
intervention Names
Drug: Celecoxib
Drug: ADT
label
Arm D: Celecoxib
type
EXPERIMENTAL
description
(ADT + zoledronic acid + docetaxel + prednisolone) NO LONGER RECRUITING
intervention Names
Drug: Docetaxel
Drug: Prednisolone
Drug: ADT
Drug: Zoledronic Acid
label
Arm E: Zoledronic Acid & Docetaxel
type
EXPERIMENTAL
description
(ADT + zoledronic acid + celecoxib) NO LONGER RECRUITING
intervention Names
Drug: Celecoxib
Drug: ADT
Drug: Zoledronic Acid
label
Arm F: Zoledronic Acid & Celecoxib
type
EXPERIMENTAL
description
(ADT + abiraterone acetate + prednisolone) NO LONGER RECRUITING
intervention Names
Drug: Prednisolone
Drug: ADT
Drug: Abiraterone
label
Arm G: Abiraterone
type
EXPERIMENTAL
description
(ADT + radiotherapy to the prostate) NO LONGER RECRUITING
intervention Names
Drug: ADT
Radiation: Radiotherapy to the prostate
label
Arm H: M1 RT
type
EXPERIMENTAL
description
(ADT + abiraterone + enzalutamide + Prednisolone) NO LONGER RECRUITING
intervention Names
Drug: Prednisolone
Drug: ADT
Drug: Abiraterone
Drug: Enzalutamide
label
Arm J: Abiraterone * Enzalutamide
type
EXPERIMENTAL
description
(ADT + Metformin) RECRUITING IN SELECTED SITES
intervention Names
Drug: ADT
Drug: Metformin
label
Arm K: Metformin
type
EXPERIMENTAL
description
(Transdermal oestradiol) RECRUITING
intervention Names
Drug: Transdermal Oestradiol
label
Arm L: tE2
type
EXPERIMENTAL

interventions

arm Group Labels
Arm D: Celecoxib
Arm F: Zoledronic Acid & Celecoxib
name
Celecoxib
other Names
Celebrex
type
DRUG
arm Group Labels
Arm C: Docetaxel
Arm E: Zoledronic Acid & Docetaxel
name
Docetaxel
other Names
Taxotere
type
DRUG
arm Group Labels
Arm C: Docetaxel
Arm E: Zoledronic Acid & Docetaxel
Arm G: Abiraterone
Arm J: Abiraterone * Enzalutamide
name
Prednisolone
other Names
Prednisone
type
DRUG
arm Group Labels
Arm A: Standard of Care
Arm B: Zoledronic Acid
Arm C: Docetaxel
Arm D: Celecoxib
Arm E: Zoledronic Acid & Docetaxel
Arm F: Zoledronic Acid & Celecoxib
Arm G: Abiraterone
Arm H: M1 RT
Arm J: Abiraterone * Enzalutamide
Arm K: Metformin
name
ADT
other Names
Androgen Deprivation Therapy
type
DRUG
arm Group Labels
Arm B: Zoledronic Acid
Arm E: Zoledronic Acid & Docetaxel
Arm F: Zoledronic Acid & Celecoxib
name
Zoledronic Acid
other Names
Zometa
type
DRUG
arm Group Labels
Arm G: Abiraterone
Arm J: Abiraterone * Enzalutamide
name
Abiraterone
other Names
Zytiga
type
DRUG
arm Group Labels
Arm H: M1 RT
name
Radiotherapy to the prostate
other Names
RT
type
RADIATION
arm Group Labels
Arm J: Abiraterone * Enzalutamide
name
Enzalutamide
other Names
Xtandi
type
DRUG
arm Group Labels
Arm K: Metformin
name
Metformin
other Names
Metformin Hydrochloride
type
DRUG
arm Group Labels
Arm L: tE2
name
Transdermal Oestradiol
other Names
Progynova TS
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

Multi-arm Multi-Stage

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 11992
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Time to mortality
measure
Overall survival
time Frame
1:Not applicable

secondary Outcomes

description
Report of time from initiation of treatment to the first progression event of each patient
measure
Failure-free survival
time Frame
1:Not applicable
description
Reporting the comparison of costs associated with the additional treatments provided and the survival gain attributed to the additional treatments, to SOC alone.
measure
Cost effectiveness by EuroQol
time Frame
1:Not applicable
description
Determination of changes in quality of life with interventions
measure
Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item
time Frame
1:Not applicable
description
Reporting the incidence, type and severity of side effects within the trial population. CTCAE v4.0 will be used to classify the events names and severity.
measure
Number of participants with treatment-related side effects as assessed by CTCAE v4.0
time Frame
1:Not applicable
description
Reporting the incidence and types of skeletal related events
measure
Skeletal related events
time Frame
1:Not applicable
description
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.
measure
Biochemical failure
time Frame
1:Not applicable
description
Reporting the incidence of mortality without a progression event
measure
Progression-free survival
time Frame
1:Not applicable
description
Reporting the incidence and severity of lymph node events
measure
Lymph node progression
time Frame
1:Not applicable
description
Reporting the incidence and severity of distant metastatic events
measure
Distant metastases
time Frame
1:Not applicable
description
Identifying and reporting the treatments used in second line treatment. Incidence and types of treatments.
measure
Treatment for progression
time Frame
1:Not applicable
description
Reporting the mortality attributed to Prostate Cancer
measure
Disease-specific survival
time Frame
1:Not applicable
description
Reporting the mortality not attributed to Prostate Cancer
measure
Non-prostate cancer death
time Frame
1:Not applicable

Full study description

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.

Source references

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.
pmid
19519885
type
BACKGROUND
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.
pmid
22978443
type
BACKGROUND
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.
pmid
23578233
type
BACKGROUND
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.
pmid
24985962
type
BACKGROUND
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.
pmid
25301760
type
BACKGROUND
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.
pmid
26606329
type
BACKGROUND
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.
pmid
27450106
type
BACKGROUND
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.
pmid
29388336
type
BACKGROUND
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.
pmid
18728279
type
BACKGROUND
citation
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.
pmid
18990168
type
RESULT
citation
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.
pmid
22452894
type
RESULT
citation
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.
pmid
26718929
type
RESULT