Improving outcomes for men with prostate cancer

Lead Research Organisation: MRC Clinical Trials Unit

Abstract

We seek to improve outcomes, reduce side-effects and reduce over-diagnosis and over-treatment in the most common male cancer: prostate cancer.|Prostate cancer is a big problem. It is increasingly common (30,000 new UK cases in 2005), particularly earlier stages of disease. We need to improve outcomes.|In recent years, we have shown that bisphosphonate drugs may make men with metastases live longer, that men live longer if given radiotherapy with hormone therapy (the mainstay of treatment for more advanced disease) and that, in men with less advanced disease, higher doses of radiotherapy can give better prostate cancer outcomes without increasing unwanted effects when using modern radiotherapy equipment.|We have 3 studies open to recruitment and one to open. STAMPEDE, for men starting hormone therapy, uses new research methods to assess three quite different drugs (chemotherapy, bone-protecting drug, cox-2 inhibitor) alone or in pairs, each with standard hormone therapy. PATCH is looking at a different way of giving hormone therapy to reduce toxicity and improve outcomes. RADICALS studies when and how best to use radiotherapy and hormone therapy after surgery (radical prostatectomy) for prostate cancer, balancing cancer outcomes with potential unwanted effects. The new study uses magnetic resonance imaging to diagnose cancers that require treatment from those that do not.

Technical Summary

We seek to improve outcomes, reduce side-effects and reduce over-diagnosis and over-treatment in the most common male cancer: prostate cancer.|Prostate cancer is a big problem. It is increasingly common (30,000 new UK cases in 2005), particularly with diagnosis of earlier stages of disease. Most men may develop prostate cancer if they live sufficiently long. The prognosis for men with clinically relevant, high-risk prostate cancer has not greatly improved for many years and requires studying. Many prostate tumours are slow growing and remain clinically unimportant. Men with early stage disease are likely to die with than of prostate cancer. Here, we must balance providing effective treatment with avoiding unwanted treatment side-effects. |Our programme aims to improve outcomes, especially survival, for men with prostate cancer using novel approaches or novel methods. We wish to reduce over-diagnosis of clinically irrelevant tumours and reduce over-treatment. We wish to design and implement methods for speeding up trials and prostate cancer is a good testing ground for this.|In recent years, we have shown that:|a first-generation bisphosphonate drug may make men with metastases live longer (PR05, ISRCTN38477744) but not men with earlier disease (PR04, ISRCTN61384873)|men live longer if given radiotherapy with hormone therapy, the mainstay of treatment for more advanced disease (PR07, NCIC PR.3, ISRCTN24991896)|in men with less advanced disease, higher doses of radiotherapy can give better prostate cancer outcomes without increasing unwanted effects when using modern conformal radiotherapy methods (RT01, ISRCTN47772397). in men with less advanced disease, higher doses of radiotherapy can give better prostate cancer outcomes without increasing unwanted effects when using modern conformal radiotherapy methods (RT01, ISRCTN47772397).|We have 3 studies open to recruitment and one to open. STAMPEDE (MRC PR08, ISRCTN78818544) is a flagship trial for men starting long-term hormone therapy. It uses new multi-arm multi-stage (MAMS) methods to supplement standard hormone therapy with 5 combinations of 3 drugs: doctaxel (a taxane chemotherapy), zoledronic acid (a potent, third-generation bisphosphonate) and celecoxib (a selective cox-2 inhibitor). More than 1500 patients from the UK and Switzerland have already joined this 6-arm trial.|PATCH (PR09, ISRCTN70406718) looks at whether oestrogen-based therapy can be administered more safely using patches rather than tablets; this method bypasses the liver pathways and cardiovascular problems should be reduced and efficacy improved. This is a novel idea. PATCH reached its target of 250 patients and will continue further.|RADICALS (PR10, NCIC PR-13, ISRCTN40814031) assesses two important questions for men who have chosen radical prostatectomy for localised prostate cancer: (i) the use and timing of post-operative radiotherapy, balancing potential efficacy and potential over-treatment; and (ii) the use of hormone therapy with any post-operative radiotherapy. RADICALS will recruit around 4,000 men from the UK, Canada, Denmark and beyond.|The new study evaluates multi-functional MRI in the diagnosis and characterisation of prostate cancer with a view to reducing over-diagnosis of clinically irrelevant tumours and over-treatment.

Publications

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Ahmed HU (2014) Can we deliver randomized trials of focal therapy in prostate cancer? in Nature reviews. Clinical oncology

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Barnett GC (2014) A genome wide association study (GWAS) providing evidence of an association between common genetic variants and late radiotherapy toxicity. in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

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Bott S (2008) Prostate cancer staging tables-A predictive model for the UK in British Journal of Medical and Surgical Urology

 
Guideline Title Prostate cancer: diagnosis and treatment (Full Guideline, Feb 2008)
Description Citation; research arm of RT01 became standard of care
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact Initial results of RT01 trial defined standard dose of radiotherapy for prostate cancer (74Gy in 2Gy fractions)
URL http://www.nice.org.uk/CG58
 
Guideline Title Prostate cancer: diagnosis and treatment (Full guidelines, Feb 2008)
Description Clinical guidelines; post-surgery, men should be considered for trials like RADICALS
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact Post-surgery, men should be considered for clinical trials like RADICALS eg participation in a clinical trial is the standard of care
 
Description Interview panel for surgical trials units (Matt Sydes)
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Guideline Title Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Description RT01 citation in ESMO guidelines
Geographic Reach Europe 
Policy Influence Type Citation in clinical guidelines
Impact Research arm of RT01 becoming standard of care.
 
Description STAMPEDE protocol
Geographic Reach Asia 
Policy Influence Type Influenced training of practitioners or researchers
Impact Results of PR07 in Nov-2011 led to a change in the control arm of the STAMPEDE trial for a substantive subset of patients. Led to the development of a further randomised question in STAMPEDE which drew in additional funding.
 
Description Add-Aspirin trial - CRUK (CTAAC) grant
Amount £3,598,674 (GBP)
Funding ID C471/A15015 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2013 
End 12/2023
 
Description CRUK Translational Research Committee (TRICC), STAMPEDE Bone Mineral Density Substudy
Amount £139,410 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2009 
End 04/2012
 
Description CRUK/CTAAC - STAMPEDE development and extension
Amount £898,898 (GBP)
Funding ID CRUK/06/019 (additional) 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 08/2012 
End 08/2020
 
Description Clincal Trial Advisory and Awards Committee (CTAAC) -- RADICALS
Amount £1,000,000 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2007 
End 06/2020
 
Description Clinical Trials Advisory and Awards Committee (CTAAC) - Late phase study - PATCH
Amount £1,288,426 (GBP)
Funding ID C17093/A12443 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2010 
End 03/2021
 
Description Clinical Trials Advisory and Awards Committee (CTAAC) -- PATCH (grant 1)
Amount £225,939 (GBP)
Funding ID C17093/A5343 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2006 
End 01/2010
 
Description Clinical Trials Advisory and Awards Committee (CTAAC) -- STAMPEDE
Amount £1,500,000 (GBP)
Funding ID CRUK/06/019 [A3804] 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2006 
End 09/2019
 
Description Health Technology Assessment -- PROMIS/Health Technology Assessment
Amount £718,007 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 11/2011 
End 11/2015
 
Description Investigator initiated study (Janssen) -- STAMPEDE
Amount £1,850,000 (GBP)
Organisation Johnson & Johnson 
Department Janssen Pharmaceuticals
Sector Private
Country United States
Start 10/2011 
End 12/2021
 
Description NIHR (HTA) -- PROMISE
Amount £718,007 (GBP)
Funding ID 09/22/67 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 09/2011 
End 09/2014
 
Description NIHR (HTA) funding for Add-Aspirin trial
Amount £3,124,812 (GBP)
Funding ID 12/01/38 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 05/2014 
End 04/2023
 
Description Prostate Cancer Charity -- RT01/PR07/The Prostate Cancer Charity, UK (via Institute of Cancer Research)
Amount £10,000 (GBP)
Organisation Prostate Cancer UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2010 
End 12/2014
 
Title Data release request form 
Description Many trials now receive requests so that their prospectively collected data can be used by external (or internal) groups for secondary purposes, including linkage to other studies. A processes used by MRC CTU Cancer Group (which is not yet at Unit SOP) has been shared with many groups and has facilitated the sharing of data between many other groups. A template sets out this process. 
Type Of Material Improvements to research infrastructure 
Year Produced 2010 
Provided To Others? Yes  
Impact Many groups have found it simple to assess incoming requests and to share data where appropriate. 
 
Title PATCH data and samples 
Description PATCH clinical trial database and repositry of blood and urine samples from trial participants. 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact The data and sample collection are ongoing. Interim analyses of trial data have resulted in a publication (PMID: 18422771) and presentation of results at a number of national and international conferences in 2011. 
URL http://europepmc.org/abstract/MED/18422771
 
Title PR07 dataset 
Description Long-term prospectively-collected patient-level data from the PR07 RCT of hormone therapy alone vs hormone therapy plus radiotherapy. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact (1) First trial results were published in 2011 (2) Long-term trial results were presented in 2012 and will soon be submitted for publication (3) External collaborators are trying to retrospectively collect biological samples and should be able to access data if they are successful 
 
Title PROMIS specimen bank 
Description Samples of blood, urine and semen from patients at risk of prostate cancer (all patients enroled in PRMIS study) will be used to identify biomarkers of risk for clinically significant prostate cancer (discriminators of low-risk vs high-risk disease). 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact Material now being collected. It will not be used until there are sufficient numbers of PROMIS patients with and without evidence of cancer. 
 
Title RADICALS database 
Description Clinical database for RADICALS 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Results awaited 
 
Title RT01 Quality of Life dataset 
Description Quality of life data from RT01 trial 
Type Of Material Improvements to research infrastructure 
Year Produced 2009 
Provided To Others? Yes  
Impact None yet. Analysis led by ICR CTSU after transfer. 
 
Title RT01 clinical database 
Description Clinical data from the RT01 trial 
Type Of Material Biological samples 
Year Produced 2010 
Provided To Others? Yes  
Impact (1) Randomised data were published in 2007 (2) Updated results publication in 2014 (3) Data have been shared with the RAPPER group at the University of Manchester 
 
Title STAMPEDE database 
Description 1. STAMPEDE clinical database 2. STAMPEDE genetic translational substudy database 3. STAMPEDE bone mineral density substudy database 
Type Of Material Biological samples 
Provided To Others? No  
Impact None, yet. Discussions are ongoing for people to start to gain access. 
 
Title Add-Aspirin trial database 
Description A secure database with built in checks/validations, as well as functionality for producing reports, has been developed in-house to record all data collected in the trial. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Due to the size and scope of the planned trial (;10,000 participants with four different tumour types), the database is expected to provide a rich resource of information for use in future research beyond the original trial question. The data will be made available to other researchers via an application process. 
 
Description Add-Aspirin - Tata Memorial Hospital 
Organisation Tata Memorial Hospital
Country India 
Sector Hospitals 
PI Contribution Leading the Add-Aspirin trial; management of the trial in the UK; oversight and mentoring of the research group at the Tata Memorial Hospital who will manage Indian participation in the trial.
Collaborator Contribution Management and oversight of the Add-Aspirin trial in India.
Impact In terms of the Add-Aspirin trial, the collaboration will speed up delivery of the research and enable demonstration of the health intervention in a range of settings, increasing the potential global impact of the results. Additionally, the work is facilitating development of a cancer research network in India and will pave the way for future collaborative projects.
Start Year 2013
 
Description Add-Aspirin Trial 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution application for Add-Aspirin trial funding
Collaborator Contribution funding from CRUK for Add-Aspirin Trial
Impact trial in setup phase
Start Year 2013
 
Description Add-Aspirin trial - Bayer Pharmaceuticals PLC 
Organisation Bayer
Department Bayer HealthCare
Country Germany 
Sector Private 
PI Contribution We approached Bayer to supply the drugs for the Add-Aspirin trial.
Collaborator Contribution Bayer Pharmaceuticals are supplying the Add-Aspirin trial medication (100mg aspirin tablets, 300mg aspirin tablets and matched placebos) free of charge.
Impact Contract signed, no output to date. The trial is currently in set-up.
Start Year 2014
 
Description NCIC PR.3 / MRC PR07 trial (NCT00002633) 
Organisation Canadian Cancer Society
Department Canadian Cancer Society Research Institute
Country Canada 
Sector Academic/University 
PI Contribution Revision of design; coordination of UK elements of trial; scientific input and interpretation.
Collaborator Contribution Design, central coordination and analysis of trial This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Long-term results will be published in a high-impact oncology journal late in 2014 (provisional acceptance). A companion quality of life paper has been submitted to the same journal. A paper on the impact of the findings has been submitted in Oct-2014
Impact Clinical trial successfully recruited. Intermediate results released by IDMC and presented as abstracts at ASCO, ASTRO and NCRI conferences in 2010. Paper published in 2011: 22056152. Final results pending publication. Results show how hundreds of life years have been saved by sites acting on these findings.
Start Year 2006
 
Description NCIC PR.3 / MRC PR07 trial (NCT00002633) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Prostate Cancer CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Revision of design; coordination of UK elements of trial; scientific input and interpretation.
Collaborator Contribution Design, central coordination and analysis of trial This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Long-term results will be published in a high-impact oncology journal late in 2014 (provisional acceptance). A companion quality of life paper has been submitted to the same journal. A paper on the impact of the findings has been submitted in Oct-2014
Impact Clinical trial successfully recruited. Intermediate results released by IDMC and presented as abstracts at ASCO, ASTRO and NCRI conferences in 2010. Paper published in 2011: 22056152. Final results pending publication. Results show how hundreds of life years have been saved by sites acting on these findings.
Start Year 2006
 
Description NCIC PR.3 / MRC PR07 trial (NCT00002633) 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Revision of design; coordination of UK elements of trial; scientific input and interpretation.
Collaborator Contribution Design, central coordination and analysis of trial This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Long-term results will be published in a high-impact oncology journal late in 2014 (provisional acceptance). A companion quality of life paper has been submitted to the same journal. A paper on the impact of the findings has been submitted in Oct-2014
Impact Clinical trial successfully recruited. Intermediate results released by IDMC and presented as abstracts at ASCO, ASTRO and NCRI conferences in 2010. Paper published in 2011: 22056152. Final results pending publication. Results show how hundreds of life years have been saved by sites acting on these findings.
Start Year 2006
 
Description PATCH (MRC PR09) trial (NCT00303784) 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination, analysis and interpretation
Collaborator Contribution The trial is supported by the National Cancer Research Institute Prostate Clinical Studies Group. It is a collaboration with the National Cancer Research Network (NCRN, a component of NIHR and funded by the English Dept of Health) and corresponding networks in the other UK nations, and specifically includes all the staff at each of the clinical sites that are participating in the trial. Each site identifies patients potentially suitable for the trial, obtains informed consent, treats and follows up patients within the trial, and provides data through completion and return of case report forms. The NCRN provides infrastructure funding for clinical trials. Imperial College is the sponsor of the trial and Cancer Research UK provide funding for the trial.
Impact This is a multidisciplinary clinical trial (oncology, urology, pathology, statistics, operations). Recruitment to the trial is ongoing and so the principal outcomes have not yet been realised. Outputs to date include publication of a systematic review, as well as some early data from the trial (PMIDs: 18422771, 18268497), and presentation of the results of the first stage of the study at a number of national and international conferences in 2011.
 
Description PATCH (MRC PR09) trial (NCT00303784) 
Organisation Imperial College London
Department Faculty of Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Scientific design, central coordination, analysis and interpretation
Collaborator Contribution The trial is supported by the National Cancer Research Institute Prostate Clinical Studies Group. It is a collaboration with the National Cancer Research Network (NCRN, a component of NIHR and funded by the English Dept of Health) and corresponding networks in the other UK nations, and specifically includes all the staff at each of the clinical sites that are participating in the trial. Each site identifies patients potentially suitable for the trial, obtains informed consent, treats and follows up patients within the trial, and provides data through completion and return of case report forms. The NCRN provides infrastructure funding for clinical trials. Imperial College is the sponsor of the trial and Cancer Research UK provide funding for the trial.
Impact This is a multidisciplinary clinical trial (oncology, urology, pathology, statistics, operations). Recruitment to the trial is ongoing and so the principal outcomes have not yet been realised. Outputs to date include publication of a systematic review, as well as some early data from the trial (PMIDs: 18422771, 18268497), and presentation of the results of the first stage of the study at a number of national and international conferences in 2011.
 
Description PATCH (MRC PR09) trial (NCT00303784) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Prostate Cancer CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination, analysis and interpretation
Collaborator Contribution The trial is supported by the National Cancer Research Institute Prostate Clinical Studies Group. It is a collaboration with the National Cancer Research Network (NCRN, a component of NIHR and funded by the English Dept of Health) and corresponding networks in the other UK nations, and specifically includes all the staff at each of the clinical sites that are participating in the trial. Each site identifies patients potentially suitable for the trial, obtains informed consent, treats and follows up patients within the trial, and provides data through completion and return of case report forms. The NCRN provides infrastructure funding for clinical trials. Imperial College is the sponsor of the trial and Cancer Research UK provide funding for the trial.
Impact This is a multidisciplinary clinical trial (oncology, urology, pathology, statistics, operations). Recruitment to the trial is ongoing and so the principal outcomes have not yet been realised. Outputs to date include publication of a systematic review, as well as some early data from the trial (PMIDs: 18422771, 18268497), and presentation of the results of the first stage of the study at a number of national and international conferences in 2011.
 
Description PATCH (MRC PR09) trial (NCT00303784) 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination, analysis and interpretation
Collaborator Contribution The trial is supported by the National Cancer Research Institute Prostate Clinical Studies Group. It is a collaboration with the National Cancer Research Network (NCRN, a component of NIHR and funded by the English Dept of Health) and corresponding networks in the other UK nations, and specifically includes all the staff at each of the clinical sites that are participating in the trial. Each site identifies patients potentially suitable for the trial, obtains informed consent, treats and follows up patients within the trial, and provides data through completion and return of case report forms. The NCRN provides infrastructure funding for clinical trials. Imperial College is the sponsor of the trial and Cancer Research UK provide funding for the trial.
Impact This is a multidisciplinary clinical trial (oncology, urology, pathology, statistics, operations). Recruitment to the trial is ongoing and so the principal outcomes have not yet been realised. Outputs to date include publication of a systematic review, as well as some early data from the trial (PMIDs: 18422771, 18268497), and presentation of the results of the first stage of the study at a number of national and international conferences in 2011.
 
Description PR04 and PR05 trials (ISRCTN61384873, ISRCTN38477744) 
Organisation F. Hoffmann-La Roche AG
Country Global 
Sector Private 
PI Contribution Scientific design, central coordination, analysis and interpretation of PR04 and PR05 trials
Collaborator Contribution Roche: Free drug and distribution, plus an educational grant This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Published results of led to the development of the STAMPEDE trial (NCT00268476) 19674936 12953084 17505072 Long-term results have been published in 2009. No further follow-up will happen at trial sites
 
Description PR04 and PR05 trials (ISRCTN61384873, ISRCTN38477744) 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination, analysis and interpretation of PR04 and PR05 trials
Collaborator Contribution Roche: Free drug and distribution, plus an educational grant This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Published results of led to the development of the STAMPEDE trial (NCT00268476) 19674936 12953084 17505072 Long-term results have been published in 2009. No further follow-up will happen at trial sites
 
Description PROMIS (MRC PR11) study 
Organisation Institute of Cancer Research UK
Country United Kingdom 
Sector Academic/University 
PI Contribution Scientific design, coordination, analysis and interpretation of PROMIS trials
Collaborator Contribution PROMIS is run in collaboration with the NCRI prostate cancer CSG which encourages national participation in the trialThis trial is a collaboration with the NCRN which provides infrastructure support for conducting studies in sites across the UKThe MRC CTU and UCL jointly developed and designed PROMIS. The NIHR grant of £2,340,212 is split between UCL who are study sponsors and the MRC CTU who have delegated authority to coordinate and analyse the study. UCL will also be one of the main centres recruiting patients. Participating sites are responsible for identification, consent and registering of PROMIS patients, administration of protocol procedures, management and follow up of patients and provision of patient study data through completion of MRC CTU designed case report forms.ICR has received funding from the Prostate Cancer Charity for the collection, storage and analsysis of samples provided by consenting patients in the PROMIS study. MRC CTU, UCL and ICR will be collaborating to facilitate translational research arising from PROMIS, especially in relation to biomarkers.
Impact Study now in pilot phase and an additional 5 sites are opening. Central review of pathology and imaging will be done at UCL, and all data collated and analysed by MRC CTU.
Start Year 2010
 
Description PROMIS (MRC PR11) study 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, coordination, analysis and interpretation of PROMIS trials
Collaborator Contribution PROMIS is run in collaboration with the NCRI prostate cancer CSG which encourages national participation in the trialThis trial is a collaboration with the NCRN which provides infrastructure support for conducting studies in sites across the UKThe MRC CTU and UCL jointly developed and designed PROMIS. The NIHR grant of £2,340,212 is split between UCL who are study sponsors and the MRC CTU who have delegated authority to coordinate and analyse the study. UCL will also be one of the main centres recruiting patients. Participating sites are responsible for identification, consent and registering of PROMIS patients, administration of protocol procedures, management and follow up of patients and provision of patient study data through completion of MRC CTU designed case report forms.ICR has received funding from the Prostate Cancer Charity for the collection, storage and analsysis of samples provided by consenting patients in the PROMIS study. MRC CTU, UCL and ICR will be collaborating to facilitate translational research arising from PROMIS, especially in relation to biomarkers.
Impact Study now in pilot phase and an additional 5 sites are opening. Central review of pathology and imaging will be done at UCL, and all data collated and analysed by MRC CTU.
Start Year 2010
 
Description PROMIS (MRC PR11) study 
Organisation National Cancer Research Institute (NCRI)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, coordination, analysis and interpretation of PROMIS trials
Collaborator Contribution PROMIS is run in collaboration with the NCRI prostate cancer CSG which encourages national participation in the trialThis trial is a collaboration with the NCRN which provides infrastructure support for conducting studies in sites across the UKThe MRC CTU and UCL jointly developed and designed PROMIS. The NIHR grant of £2,340,212 is split between UCL who are study sponsors and the MRC CTU who have delegated authority to coordinate and analyse the study. UCL will also be one of the main centres recruiting patients. Participating sites are responsible for identification, consent and registering of PROMIS patients, administration of protocol procedures, management and follow up of patients and provision of patient study data through completion of MRC CTU designed case report forms.ICR has received funding from the Prostate Cancer Charity for the collection, storage and analsysis of samples provided by consenting patients in the PROMIS study. MRC CTU, UCL and ICR will be collaborating to facilitate translational research arising from PROMIS, especially in relation to biomarkers.
Impact Study now in pilot phase and an additional 5 sites are opening. Central review of pathology and imaging will be done at UCL, and all data collated and analysed by MRC CTU.
Start Year 2010
 
Description PROMIS (MRC PR11) study 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Scientific design, coordination, analysis and interpretation of PROMIS trials
Collaborator Contribution PROMIS is run in collaboration with the NCRI prostate cancer CSG which encourages national participation in the trialThis trial is a collaboration with the NCRN which provides infrastructure support for conducting studies in sites across the UKThe MRC CTU and UCL jointly developed and designed PROMIS. The NIHR grant of £2,340,212 is split between UCL who are study sponsors and the MRC CTU who have delegated authority to coordinate and analyse the study. UCL will also be one of the main centres recruiting patients. Participating sites are responsible for identification, consent and registering of PROMIS patients, administration of protocol procedures, management and follow up of patients and provision of patient study data through completion of MRC CTU designed case report forms.ICR has received funding from the Prostate Cancer Charity for the collection, storage and analsysis of samples provided by consenting patients in the PROMIS study. MRC CTU, UCL and ICR will be collaborating to facilitate translational research arising from PROMIS, especially in relation to biomarkers.
Impact Study now in pilot phase and an additional 5 sites are opening. Central review of pathology and imaging will be done at UCL, and all data collated and analysed by MRC CTU.
Start Year 2010
 
Description RADICALS (MRC PR10) trial (NCT00541047) 
Organisation Canadian Cancer Society
Department Canadian Cancer Society Research Institute
Country Canada 
Sector Academic/University 
PI Contribution Design, central coordination and analysis of the RADICALS trial
Collaborator Contribution Coordination of RADICALS trial in Canada This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results are awaited; accrual is ongoing. Outputs only relate to trial promotion and justification. All papers are listed in the previous section. Sites in Denmark and Ireland have been activated. Sites in Spain and Sweden are considering the trial. A planned collaboration with the USA (through RTOG) failed at the final hurdle. A meta-analysis of relevant trials is being planned prospectively call ARTISTIC - see MC_U122861323. This involves collaboration with France (Unicancer), Australasia (TROG), USA (RTOG) and Europe (EORTC).
Start Year 2006
 
Description RADICALS (MRC PR10) trial (NCT00541047) 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Design, central coordination and analysis of the RADICALS trial
Collaborator Contribution Coordination of RADICALS trial in Canada This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results are awaited; accrual is ongoing. Outputs only relate to trial promotion and justification. All papers are listed in the previous section. Sites in Denmark and Ireland have been activated. Sites in Spain and Sweden are considering the trial. A planned collaboration with the USA (through RTOG) failed at the final hurdle. A meta-analysis of relevant trials is being planned prospectively call ARTISTIC - see MC_U122861323. This involves collaboration with France (Unicancer), Australasia (TROG), USA (RTOG) and Europe (EORTC).
Start Year 2006
 
Description RADICALS (MRC PR10) trial (NCT00541047) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Prostate Cancer CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Design, central coordination and analysis of the RADICALS trial
Collaborator Contribution Coordination of RADICALS trial in Canada This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results are awaited; accrual is ongoing. Outputs only relate to trial promotion and justification. All papers are listed in the previous section. Sites in Denmark and Ireland have been activated. Sites in Spain and Sweden are considering the trial. A planned collaboration with the USA (through RTOG) failed at the final hurdle. A meta-analysis of relevant trials is being planned prospectively call ARTISTIC - see MC_U122861323. This involves collaboration with France (Unicancer), Australasia (TROG), USA (RTOG) and Europe (EORTC).
Start Year 2006
 
Description RADICALS (MRC PR10) trial (NCT00541047) 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Design, central coordination and analysis of the RADICALS trial
Collaborator Contribution Coordination of RADICALS trial in Canada This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results are awaited; accrual is ongoing. Outputs only relate to trial promotion and justification. All papers are listed in the previous section. Sites in Denmark and Ireland have been activated. Sites in Spain and Sweden are considering the trial. A planned collaboration with the USA (through RTOG) failed at the final hurdle. A meta-analysis of relevant trials is being planned prospectively call ARTISTIC - see MC_U122861323. This involves collaboration with France (Unicancer), Australasia (TROG), USA (RTOG) and Europe (EORTC).
Start Year 2006
 
Description RT01 trial and RAPPER (NCT19836155) 
Organisation Institute of Cancer Research UK
Country United Kingdom 
Sector Academic/University 
PI Contribution Design, central coordination, analysis and scientific interpretation of RT01 trial
Collaborator Contribution Design and development of physics-based substudies using data from RT01 Design and running of RAPPER study to which many RT01 patients have contributed blood samples and RT01 trial toxicity data are provided This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, physics, radiography, statistics, operations. Various publications: 15297138, 15622611, 16828908, 16949694, 17155990, 17391791, 17482880, 18343725, 18565744, 19540054, 19826203, 19836155, 20092961, 20096945, 21470834, 24974847, 24785509.
Start Year 2006
 
Description RT01 trial and RAPPER (NCT19836155) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Prostate Cancer CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Design, central coordination, analysis and scientific interpretation of RT01 trial
Collaborator Contribution Design and development of physics-based substudies using data from RT01 Design and running of RAPPER study to which many RT01 patients have contributed blood samples and RT01 trial toxicity data are provided This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, physics, radiography, statistics, operations. Various publications: 15297138, 15622611, 16828908, 16949694, 17155990, 17391791, 17482880, 18343725, 18565744, 19540054, 19826203, 19836155, 20092961, 20096945, 21470834, 24974847, 24785509.
Start Year 2006
 
Description RT01 trial and RAPPER (NCT19836155) 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Design, central coordination, analysis and scientific interpretation of RT01 trial
Collaborator Contribution Design and development of physics-based substudies using data from RT01 Design and running of RAPPER study to which many RT01 patients have contributed blood samples and RT01 trial toxicity data are provided This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, physics, radiography, statistics, operations. Various publications: 15297138, 15622611, 16828908, 16949694, 17155990, 17391791, 17482880, 18343725, 18565744, 19540054, 19826203, 19836155, 20092961, 20096945, 21470834, 24974847, 24785509.
Start Year 2006
 
Description RT01 trial and RAPPER (NCT19836155) 
Organisation The Christie NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution Design, central coordination, analysis and scientific interpretation of RT01 trial
Collaborator Contribution Design and development of physics-based substudies using data from RT01 Design and running of RAPPER study to which many RT01 patients have contributed blood samples and RT01 trial toxicity data are provided This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.The trial is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial
Impact Clinical trial. Multi-disciplinary: oncology, physics, radiography, statistics, operations. Various publications: 15297138, 15622611, 16828908, 16949694, 17155990, 17391791, 17482880, 18343725, 18565744, 19540054, 19826203, 19836155, 20092961, 20096945, 21470834, 24974847, 24785509.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Astellas Pharma
Country Japan 
Sector Private 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Johnson & Johnson
Department Janssen-Cilag
Country Global 
Sector Private 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Prostate Cancer CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Novartis
Country Global 
Sector Private 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Pfizer Ltd
Country United Kingdom 
Sector Private 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Sanofi
Department Aventis
Country France 
Sector Private 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Description STAMPEDE (MRC PR08) trial (NCT00268476) 
Organisation Swiss Group for Cancer Clinical Research (SAKK)
Country Switzerland 
Sector Academic/University 
PI Contribution Scientific design, central coordination and analysis of the STAMPEDE trial
Collaborator Contribution Pfizer: Free drug (celecoxib) and some money for distribution through Bilcare, plus educational grant. Sanofi-Aventis: Discounted drug (docetaxel) for UK. Free drug for Switzerland and some money for distribution through Bilcare, plus educational grant. Novartis: Free drug (zoledronic acid) distributed directly, plus educational grant. Janssen: Free drug (abiraterone) and full distribution costs through B&C, plus educational grant. Astellas (from Jul-2014): Free drug (enzalutamide) and full distribution costs through Bilcare, plus educational grant SAKK: Data management and coordination in Switzerland NCRI/NCRN: This trial is a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Dept of Health) and the corresponding networks in the other UK nations. It specifically includes all the staff at each of the clinical sites that have participated in this clinical trial. STAMPEDE is run in collaboration with the NCRI prostate cancer CSG which as a group encourages national participation in the trial. Sites: Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Impact Clinical trial. Multi-disciplinary: oncology, urology, statistics, operations. Results awaited; accrual ongoing. Outputs relate to promoting methodology: all listed above. PubMed ID 19519885. PubMed ID 18990168. PubMed ID 18760574. Efforts to collaborate with a Japanese research group were unsuccessful (PubMed ID 21615523), as were efforts to engage other European organisation Recent editorial: 24985962 Recruitment was stopped early to two research arms following a pre-planned interim analysis. Publications are in development. Research was activated to a new research comparison in Nov-2011; and a further new research comparison will be activated in Jan-2013.
Start Year 2006
 
Title PR07 trial results 
Description Trial results demonstrated that the addition of radiotherapy to long-term hormone therapy prolongs survival for men with locally advanced, non-metastatic prostate cancer. 
IP Reference  
Protection Protection not required
Year Protection Granted 2011
Licensed No
Impact Impact on clinical practice in the UK.
 
Title RT01 trial results 
Description First results from RT01 demonstrated that dose-escalated radiotherapy was better than standard-dose radiotherapy for men with localised and locally advanced prostate cancer. 
IP Reference  
Protection Protection not required
Year Protection Granted 2007
Licensed No
Impact Standard-of-care was changed in the UK.
 
Title Add-Aspirin 
Description Add-Aspirin is a phase III, double-blind, placebo-controlled randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours. It is currently in the set-up phase and funding has been secured from CRUK. Further funding applications are ongoing. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Initial development
Year Development Stage Completed 2013
Development Status Actively seeking support
Impact under development. Novel methodology proposed including 4 individually powered trials integrated into one over-arching trial 
 
Title PATCH 
Description PATCH is a randomised, non-inferiority, phase III trial comparing the clinical efficacy and side effect profile of transdermal oestrogen patches with Luteinising Hormone Releasing Hormone agonists (LHRHa) in the treatment of locally advanced and metastatic prostate cancer. Transcutaneous oestrogen avoids first-pass hepatic metabolism and therefore is not expected to be associated with the same level of cardiovascular (CVS) system toxicity as oral oestrogen. The primary outcome measures will be overall survival and progression-free survival. The secondary outcome measures include prostate cancer specific survival, hormone levels, CVS and other toxicity, and quality of life. Data from the trial so far have shown promising evidence of the safety and efficacy of the oestrogen patches. Results from the first stage of the trial which aimed to assess the safety and activity of the patches have been published (n= 254), showing the patches produced castrate levels of testosterone similar to LHRHa, with no evidence of excess CVS toxicity. During the second stage, a pre-planned interim analysis (n=638) reviewed by the Independent Data Monitoring Committee in June 2013 led to the trial being extended for a phase III evaluation of the patch efficacy. For a summary of a systematic review on the use of parenteral oestrogens in prostate cancer undertaken to inform the design of this study please see Appendix H or access the following link: http://www.york.ac.uk/inst/crd/pdf/parentoestrogen.pdf). 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2006
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Results from a bone health sub-study embedded within PATCH have shown transdermal oestrogen protects against the bone mineral density loss seen with LHRHa. However, the clinical efficacy of the patches needs confirming within a phase III trial setting before they can be considered as part of standard care in prostate cancer. 
URL http://www.tevauk.com/mediafile/id/7480.pdf
 
Title PR04 
Description Bisphosphonate drug for non-metastatic prostate cancer 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2009
Development Status Closed
Clinical Trial? Yes
UKCRN/ISCTN Identifier ISRCTN61384873
Impact Demonstrated no improvement in overall survival by using a bisphosphonate drug for non-metastatic prostate cancer. Led to development of STAMPEDE. 
URL http://www.controlled-trials.com/ISRCTN61384873
 
Title PR05 
Description Bisphosphonate drug for men with metastatic prostate cancer. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2009
Development Status Closed
Clinical Trial? Yes
Impact Demonstrated an improvement in overall survival by using a bisphosphonate drug for non-metastatic prostate cancer. Did not change practice. Led to development of STAMPEDE. 
URL http://www.controlled-trials.com/ISRCTN38477744
 
Title PR07 
Description Standard of care for men with locally advance prostate cancer was hormone therapy alone, although many UK centres were also already giving radiotherapy. This randomised controlled trial assessed: (1) Hormone therapy alone (2) Hormone therapy plus radiotherapy Recruitment started in Canada in 1995, but most patients were recruited in the UK between 1999 and 2005 
Type Therapeutic Intervention - Radiotherapy
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Closed
Clinical Trial? Yes
Impact A survival advantage was demonstrated with the addition of radiotherapy. Standard practice in the UK has changed, including in the backbone of therapy in this group of men in the STAMPEDE trial. First results were published in 2011. Updated results have been presented but the data are not yet published. 
URL http://www.controlled-trials.com/ISRCTN24991896
 
Title PROMIS 
Description Testing the use of Multi-Parametric Magnetic Resonance Imaging (MP-MRI) in the diagnosis of prostate cancer 
Type Diagnostic Tool - Imaging
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2011
Development Status Under active development/distribution
Clinical Trial? Yes
Impact The results aim to inform the role of MP-MRI in the diagnostic pathway for prostate cancer. 
URL http://www.controlled-trials.com/ISRCTN16082556/
 
Title RADICALS 
Description Two randomised controlled trials in overlapping groups of patients. (1) In men who have recently undergone surgery for prostate cancer, should radiotherapy by used: :: Adjuvantly in all men :: In some men, only if PSA values start to increase (2) In men having radiotherapy to the prostate bed any time after surgery for prostate cancer, how much hormone therapy, if any, should also be given: :: None :: Short-term - 6 months :: Long-term - 2 years 
Type Therapeutic Intervention - Radiotherapy
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2008
Development Status Under active development/distribution
Clinical Trial? Yes
Impact No results due for many years yet. Trial designed to efficiently address a number of questions simultaneously. 
URL https://clinicaltrials.gov/show/NCT00541047
 
Title RT01 
Description Using traditional machines, radiotherapy dose were limited by toxicity. A new generation of radiotherapy machines could use "conformal" technique which allowed for shaping of the radiotherapy beams around normal structures. This should decrease toxicity. If toxicity is increased with normal doses, could the dose be increased and would this allow improved short and long-term outcomes. Patients were randomised to: :: Standard - 64 Gray over 32 fractions :: Escalated - 74 Gray over 37 fractions 
Type Therapeutic Intervention - Radiotherapy
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Closed
Clinical Trial? Yes
Impact The trial improved short-term outcomes in 2007 and this led to a change in the standard of care. However, this approach has not demonstrated an improvement in overall survival in current, updated analyses. These results have been presented and a paper will soon be submitted. 
URL http://www.controlled-trials.com/ISRCTN47772397
 
Title STAMPEDE - M1|RT comparison (AH) 
Description Radiotherapy to the prostate for men whose cancer has already spread elsewhere Recruitment opened: Jan-2013 Ongoing 
Type Therapeutic Intervention - Radiotherapy
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Pending 
URL http://clinicaltrials.gov/show/NCT00268476
 
Title STAMPEDE - abiraterone comparison (AG) 
Description Recruitment opened: Nov-2011 Recruitment closed: Jan-2014 Follow-up ongoing 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2011
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Pending 
URL http://clinicaltrials.gov/show/NCT00268476
 
Title STAMPEDE - enzalutamide and abiraterone comparison (AJ) 
Description Recruitment opened: Jul-2014 Unlikely that this combination of treatments, which have a compelling case for being combined, would have been put together without an academic trials group taking the lead 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2014
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Pending 
URL https://clinicaltrials.gov/show/NCT00268476
 
Title STAMPEDE - original comparisons (ABCDEF) 
Description All patients receive standard care (arm "A") which is long-term hormone therapy. A subset of patients with disease that hasn't spread should also receive radiotherapy. The trial assesses a number of different treatments in addition to this standard of care: (B) zoledronic acid - a bisphosphonate (C) docetaxel - a chemotherapy (D) celecoxib - a cox-2 inhibitor (E) zoledronic acid + docetaxel (F) zoledronc acid + celecoxib (G) abiraterone - a CYP-17 inhibitor (H) radiotherapy to the prostate; only in men whose disease has already spread. Notable dates: Oct-2005: accrual initiated to arms A, B, C, D, E and F Apr-2011: accrual stopped early to arms D and F Nov-2011: accrual initiated to arm G Jan-2013: accrual initiated to arm H Mar-2013: accrual completed to arms B, C and E 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2006
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Implemented a number clinical trial method: multi-arm multi-stage trial. Demonstrated the practice and then further extended it by incorporating new research comparisons. Now the largest randomised controlled trial of treatment for me with prostate cancer. 
URL http://clinicaltrials.gov/show/NCT00268476
 
Title Add-Aspirin Drug Supply Management System 
Description A drug supply management system tailored to the trial requirements has been developed in-house to provide a secure system for coordinating all aspects of the drug supply process in the study. The drug packaging and distribution team, as well as research staff and pharmacists at participating sites will have web-based access to the system, and it will allow close oversight of the whole process by the Trials Unit team. Input from all of the relevant parties has been sought in developing the system and it has been designed in such a way that it can subsequently be adapted for use in future trials conducted at the unit. 
Type Of Technology Software 
Year Produced 2014 
Impact This in-house system may replace the need to out-source the management of drug supply processes, and so will have cost-saving implications both within Add-Aspirin and for future trials. 
 
Description Add-Aspirin trial launch meeting at NCRI conference Liverpool 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Add-Aspirin trial launch meeting- Trial promotion and training for research nurses and doctors hoping to participate in the trial at their site.

Increased requests for further information from sites interested in participating in the trial.
Year(s) Of Engagement Activity 2014
 
Description Application of MAMS trials into practice: the STAMPEDE experience (extended issues) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Presentations to other researchers who could use these methods at (1) MRC Methodology Hubs meeting, (2) Workshop on time-to-event data, (3) 1st UK Clinical Trials Methodology Conference
See another row that gives more details information.

Number of people contacting MRC CTU to ask about multi-arm multi-stage trials has increased
Year(s) Of Engagement Activity 2011
 
Description Application of MAMS trials into practice: the STAMPEDE experience (ongoing) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact There have been multiple presentations on STAMPEDE and the implementation of the MAMS design. For example, below are 36 completed or planned presentations by Trial Statistician, Matt Sydes. There are have been multiple other presentations, notably by Chief Investigator, Nick James, and CTU Director, Max Parmar.

Date Presentation Format Meeting & Venue
========================================================================================
Jan2006 MAMS trials Invited External SPCG annual meeting Stockholm, Swe
Sep2006 STAMPEDE design Invited External Colin Blakemore visit MRC CTU
Apr2007 STAMPEDE design Invited External STAMPEDE launch meeting London
Oct2007 MAMS & STAMPEDE Invited Internal Senior staff awayday RSS
Feb2008 MAMS & STAMPEDE Invited Internal Prostate group meeting MRC CTU
Nov2008 STAMPEDE design Invited External Stephen Holgate visit MRC CTU
Feb2009 MAMS trials and STAMPEDE Invited External Futility & lack-of-benefit MRC CTU
Jul2009 STAMPEDE Invited Internal Background to STAMPEDE design MRC CTU
Jul2009 STAMPEDE design Invited External STAMPEDE joint TSC & IDMC meetin London
Oct2009 Implementation of MAMS trials Invited External GSK annual global stats conferen London
Feb2010 Implementation of MAMS trials Invited External GSK UK meeting London
Mar2010 Design of MAMS trials Invited External EURAMOS Strategy Group meeting: London
May2010 Design of MAMS trials Invited External Paed Onc Stats Birmingham
Jun2010 Design of MAMS trials Invited External Seminar at Institut Gustav Rouss Paris, FR
Oct2010 STAMPEDE design Invited External STAMPEDE planning with Janssen Milan, It
Oct2010 STAMPEDE and abiraterone Invited External STAMPEDE planning with Janssen Milan, It
Jan2011 Practical Implementation of MAMS trials Invited External MRC Methods Hub Annual Meeting Birmingham
Feb2011 Statistical Implementation of MAMS trials Invited External London Hub Workship London
Jun2011 MAMS trials Invited External 6th Accredited CTUs meeting London
Oct2011 Practical Implementation of MAMS trials Submitted External Methodology Conference Bristol
Jun2011 STAMPEDE: adding abiraterone Invited External STAMPEDE planning with Janssen MRC CTU
Oct2011 MAMS trials Invited Internal Sir John Chisholm visit to CTU London
Jul2012 Practical Implementation of MAMS trials Submitted External Adaptive Trials and Multiple Com Heidelberg, Ger
Jul2012 Changes to STAMPEDE Invited Internal Cancer and Non-Infectious Diseas MRC CTU
Oct2012 MAMS trials and rare diseases Invited External RSS Medical Section RSS, London
Nov2012 Practical Implementation of MAMS trials Invited External MAMS trials workshop MRC CTU
Jan2013 MAMS trials Invited External LSHTM/CTU workshop MRC CTU
Feb2013 Plans for new arm in STAMPEDE Invited Internal Cancer and Non-Infectious Diseas MRC CTU
Mar2013 MAMS trial strategy Invited External PSP workshop London
Sep2013 MAMS trials and rare diseases Invited External IRCI workshop on trial methods f Amsterdam, NL
Nov2013 Multi-arm trials Submitted External 2nd Clinical Trials Methodology Edinburgh
Feb2014 MAMS trials Invited External Royal Free Hospital statistical London
May2014 Multi-arm trials Submitted External Society for Clinical Trials (SCT Philadelphia, PA
Oct2014 MAMS trials Invited External HTMR Network PhD meeting London
Oct2014 MAMS trials Invited External Surgical meeting Birmingham
Sep2015 MAMS trials and rare cancers Invited External ECCO 2015 Vienna


Increasing awareness of the multi-arm multi-stage design for randomised controlled trials and its implementability.
Year(s) Of Engagement Activity 2010,2011,2012,2013,2014
 
Description Clinical trials in prostate cancer - Basingstoke patient support group 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact 50 patients attended a talk on clinical trials, primarily prostate cancer. There was much interaction and many questions.

Led to talks in Manchester and Norwich
Year(s) Of Engagement Activity 2008
 
Description Clinical trials in prostate cancer - Manchester patient support group 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact 80 patients attended a talk on clinical trials, primarily prostate cancer. There was much interaction and many questions

None
Year(s) Of Engagement Activity 2009
 
Description Clinical trials in prostate cancer - Norwich patient support group 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact 50 patients attended a talk on clinical trials, primarily prostate cancer. There was much interaction and many questions

Increased awareness of research
Year(s) Of Engagement Activity 2009
 
Description Clinical trials statistics for CancerHelp 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Attend by CRUK's CancerHelp nurses and managers. Given by Matt Sydes.

Lots of comments, questions and useful discussion
Year(s) Of Engagement Activity 2011
 
Description Impact of radiotherapy on node-positive prostate cancer: data from the control arm of STAMPEDE 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact More than 1000 relevant people viewed the presentations. Discussions were stimulated. A paper is in development.

None yet (Nov-2014)
Year(s) Of Engagement Activity 2014
URL http://annonc.oxfordjournals.org/content/25/suppl_4/iv255.2.abstract
 
Description Importance of clinical trials - Prostate Cancer Charity annual conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Presentation on clinical trials to around 400 men with prostate cancer and their families

Generally well received
Year(s) Of Engagement Activity 2011
 
Description PATCH poster presentations at ASCO 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact PATCH had the following poster presentations at ASCO May 2014 (Chicago, US):
- Bone density in men receiving androgen deprivation therapy for prostate cancer, a randomised comparison between transdermal estrogen and luteinising hormone-releasing hormone agonists
- PATCH (Prostate Adenocarcinoma: TransCutaneous Hormones, PR09): A randomised controlled trial of transdermal estrogen patches versus luteinising hormone releasing hormone agonists in locally advanced and metastatic prostate cancer

The poster presentations led to several new sites expressing interests in joining the study.
Year(s) Of Engagement Activity 2014
URL http://meetinglibrary.asco.org/content/131497-144
 
Description PATCH presentation at STAMPEDE Investigators Meeting 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact A presentation of the PATCH trial highlighting the phase III extension and promoting recruitment was given at a number of regional meetings for the STAMPEDE trial investigators.

There were interests from new sites to join the study.
Year(s) Of Engagement Activity 2014
 
Description Patient engagement workshop - centenary celebrations 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Discussed research. MSy involved in discussions re STAMPEDE and RADICALS.

Uncertain
Year(s) Of Engagement Activity 2013
 
Description Prostate Cancer Support Federation newsletter (PATCH trial) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact The Prostate Cancer Support Federation (PCSF) is an organisation of UK patient-led prostate cancer support groups. An article on the PATCH trial was published in the PCSF newsletter with the aim of raising awareness of the trial, the aim of the research, and the results it has produced so far, amongst prostate cancer patients.

This, and other similar activities, have established good links with the PCSF, providing a route for future engagement with the prostate cancer patient community about CTU research.
Year(s) Of Engagement Activity 2012
 
Description Prostate cancer research at MRC CTU - Meeting with charity/patient group representatives 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Representatives from prostate cancer charities and patient advocacy groups attended a meeting at the MRC Clinical Trials Unit to learn more about the ongoing and planned prostate cancer research at the unit, and to discuss future research priorities and collaborative activities between the CTU and the charities/patient groups.

Future collaborative engagement activities are being discussed.
Year(s) Of Engagement Activity 2012
 
Description Results of MRC PR04/5 trials 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact The results of the MRC PR04 and PR05 trials were summarised and provided to doctors to give to their patients or families. Printed in 2007; updated in 2009

No direct feedback
Year(s) Of Engagement Activity 2007,2009
 
Description Results of MRC PR07 trial (media) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Press release for PR07 results in Nov-2011. Led to some printed press coverage, at least one radio interview (Matt Sydes) and many on-line news article, plus one podcast interview.

Canadian collaborators independently put out press release and received more coverage including TV
Year(s) Of Engagement Activity 2011
 
Description Results of MRC PR07 trial (participants) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Participants in your research and patient groups
Results and Impact Results summaries developed with consumers and sent to participating sites for dissemination directly to participants and relevant family members

None
Year(s) Of Engagement Activity 2011
 
Description Results of MRC PR07 trial (policy) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact New Policy and Research Impact Coordinator led development of Policy Brief aim at health professionals and policymakers

Results taken into updated NICE guidelines in the UK
Year(s) Of Engagement Activity 2011
 
Description Results of MRC RT01 trial (participants) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Results of the MRC RT01 trial were provided to doctors to pass on to patients and families

No direct feedback
Year(s) Of Engagement Activity 2007
 
Description STEMNet: Pimlico Academy 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Schools
Results and Impact Talk about the importance of clinical trials to about 30 GSCE and A-level biology students at Pimlico Academy. Organised through STEMNet

Not known
Year(s) Of Engagement Activity 2012
 
Description Update on clinical trials in prostate cancer to charities 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Representatives from 4 major charities attended to hear results from PR07 and RT01 and to be updated on ongoing research at MRC CTU.
Organised by Annabelle South and Matt Sydes.

Agreed to similar updates in the future.
Year(s) Of Engagement Activity 2011