Improving Outcomes for Men with Prostate Cancer.
Lead Research Organisation:
University College London
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 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.
Organisations
- University College London, United Kingdom (Lead Research Organisation)
- Janssen Research & Development (Collaboration)
- Gustave-Roussy Institute (Collaboration)
- Astellas Pharma (Collaboration)
- Almac Group (Collaboration)
- Salford Royal NHS Foundation Trust, United Kingdom (Collaboration)
- Imperial Cancer Research Fund (Collaboration)
- Queen Elizabeth Hospital (Collaboration)
- Institute of Cancer Research UK (Collaboration)
- King's College Hospital Charitable Trust, United Kingdom (Collaboration)
- Cardiff University, United Kingdom (Collaboration)
- Johnson & Johnson Ltd, United Kingdom (Collaboration)
- Clovis Oncology, inc (Collaboration)
- Novartis (Collaboration)
- Sanofi (Collaboration)
- University of Nottingham (Collaboration)
- University of Warwick, United Kingdom (Collaboration)
- National Cancer Research Institute (Collaboration)
- Queen's University of Belfast, United Kingdom (Collaboration)
- Cantonal Hospital St. Gallen (Collaboration)
- Medical Research Council (Collaboration)
- University of Birmingham, United Kingdom (Collaboration)
- Paoli-Calmettes Institute (Collaboration)
- Dana-Farber Cancer Institute (Collaboration)
- Pfizer Ltd (Collaboration)
- Swiss Group for Cancer Clinical Research (SAKK) (Collaboration)
- The Christie NHS Foundation Trust, Manchester (Collaboration)
- University of Manchester, Manchester, United Kingdom (Collaboration)
People |
ORCID iD |
| Mahesh Parmar (Principal Investigator) |
Publications
Ahmed M
(2016)
Common genetic variation associated with increased susceptibility to prostate cancer does not increase risk of radiotherapy toxicity.
in British journal of cancer
Andreassen CN
(2016)
Individual patient data meta-analysis shows a significant association between the ATM rs1801516 SNP and toxicity after radiotherapy in 5456 breast and prostate cancer patients.
in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
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
Brand D
(2018)
Management of Men with Prostate-specific Antigen Failure After Prostate Radiotherapy: The Case Against Early Androgen Deprivation.
in European urology
Brown LC
(2018)
Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study.
in Health technology assessment (Winchester, England)
Brundage M
(2015)
Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial.
in Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Dearnaley DP
(2014)
Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial.
in The Lancet. Oncology
El-Shater Bosaily A
(2016)
The concordance between the volume hotspot and the grade hotspot: a 3-D reconstructive model using the pathology outputs from the PROMIS trial.
in Prostate cancer and prostatic diseases
El-Shater Bosaily A
(2015)
PROMIS--Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer.
in Contemporary clinical trials
| Guideline Title | European Association of Urology Guidelines on Prostate Cancer 2015 |
| Description | EAU Guidelines on Prostate Cancer - PR05 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| URL | http://uroweb.org/wp-content/uploads/09-Prostate-Cancer_LR.pdf |
| Guideline Title | European Association of Urology Guidelines on Prostate Cancer 2015 |
| Description | EAU Guidelines on Prostate Cancer - PR07 (2011 clinical paper) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Listed in Table 6.3.3 with this citation. In text, updated results are used with an updated paper |
| URL | http://uroweb.org/wp-content/uploads/09-Prostate-Cancer_LR.pdf |
| Guideline Title | European Association of Urology Guidelines on Prostate Cancer 2015 |
| Description | EAU Guidelines on Prostate Cancer - PR07 (2015 QL paper) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation 6.3.3.3.6.4.1 MRC PR3/PR07 study - The National Cancer Institute of Canada (NCIC)/UK Medical Research Council (MRC)/Southwest Oncology Group (SWOG) intergroup PR3/PR07 study This study comprised 1,205 patients, consisting of T3-4 (n = 1057), or T2, PSA > 40 ng/mL (n = 119), or T2, PSA > 20 ng/mL and Gleason score > 8 (n = 25) and T-category unknown (n = 4), who were randomly assigned to lifelong ADT (bilateral orchidectomy or LHRH agonist), with or without radiotherapy (65-70 Gy to the prostate, with or without 45 Gy to the pelvic lymph nodes). After a median follow-up period of 6 years, the addition of radiotherapy to ADT reduced the risk of death from any cause by 23% (p = 0.03) and the risk of death due to PCa by 46% (p = 0.0001) [442, 443]. |
| URL | http://uroweb.org/wp-content/uploads/09-Prostate-Cancer_LR.pdf |
| Guideline Title | European Association of Urology Guidelines on Prostate Cancer 2015 |
| Description | EAU Guidelines on Prostate Cancer - PR07 (2015 clinical paper) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation 6.3.3.3.6.4.1 MRC PR3/PR07 study - The National Cancer Institute of Canada (NCIC)/UK Medical Research Council (MRC)/Southwest Oncology Group (SWOG) intergroup PR3/PR07 study This study comprised 1,205 patients, consisting of T3-4 (n = 1057), or T2, PSA > 40 ng/mL (n = 119), or T2, PSA > 20 ng/mL and Gleason score > 8 (n = 25) and T-category unknown (n = 4), who were randomly assigned to lifelong ADT (bilateral orchidectomy or LHRH agonist), with or without radiotherapy (65-70 Gy to the prostate, with or without 45 Gy to the pelvic lymph nodes). After a median follow-up period of 6 years, the addition of radiotherapy to ADT reduced the risk of death from any cause by 23% (p = 0.03) and the risk of death due to PCa by 46% (p = 0.0001) [442, 443]. |
| URL | http://uroweb.org/wp-content/uploads/09-Prostate-Cancer_LR.pdf |
| Guideline Title | European Association of Urology Guidelines on Prostate Cancer 2015 |
| Description | EAU Guidelines on Prostate Cancer - RT01 (2007 toxicity paper) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Cited in guidelines |
| URL | http://uroweb.org/wp-content/uploads/09-Prostate-Cancer_LR.pdf |
| Guideline Title | European Association of Urology Guidelines on Prostate Cancer 2015 |
| Description | EAU Guidelines on Prostate Cancer - RT01 (2014 clinical paper) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Table 6.3.6 and text: 6.3.3 Radiotherapy for localised PCa 6.3.3.1 Dose escalation Several randomised studies (see below) have shown that dose escalation (range 74-80 Gy) has a significant impact on 5-year survival without biochemical relapse [391-397]. These trials have generally included patients from several risk groups, and the use of neoadjuvant/adjuvant hormone therapy (see below) has varied. To date, no trials have shown that dose escalation results in an OS benefit. However, the trials have been remarkably consistent in reporting improvements in freedom from biochemical progression in patients treated with dose-escalated radiotherapy. In everyday practice, a minimum dose of > 74 Gy is recommended for EBRT + hormone therapy. Currently, it is not possible to make different recommendations according to the patient's risk group. |
| URL | http://uroweb.org/wp-content/uploads/09-Prostate-Cancer_LR.pdf |
| Guideline Title | Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up 2015 |
| Description | ESMO Guidelines on Prostate Cancer 2015 - PR07 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation The case for adding radical local treatment for men with high-risk localised and locally advanced disease is based on two randomised, controlled trials. The Scandinavian Prostate Cancer Group Study 7 (SPCG-7) trial included 875 men who received 3 months of combined androgen blockade followed by flutamide monotherapy. They were randomised by whether or not they were to receive radical radiotherapy (RT) to the prostate [14]. It showed a beneficial impact of radical RT in terms of cause-specific (11.9% versus 23.9%, P < 0.001) and overall mortality (29.6% versus 39.4%, P = 0.004). The NCIC/MRC trial randomised high-risk patients to either lifelong androgen deprivation therapy (ADT) alone or to ADT plus RT. The addition of RT improved the 7-year survival probability from 66% to 74% (P = 0.003) [15]. Recommendations • Primary ADT alone is not recommended as standard initial treatment of non-metastatic disease [III, B]. • Options for patients with high-risk or locally advanced prostate cancer include external beam RT plus hormone treatment [I, B] or RP plus pelvic lymphadenectomy [III, B]. |
| URL | http://www.ncbi.nlm.nih.gov/pubmed/26205393 |
| Guideline Title | NCCN Clinical Practice Guidelines in Oncology -- Prostate Cancer (v1.2019 -- 06-Mar-2019) |
| Description | NCCN guidelines (updated Mar-2019) - PR07 (4 papers) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| URL | https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Guideline Title | NCCN Clinical Practice Guidelines in Oncology -- Prostate Cancer (v1.2019 -- 06-Mar-2019) |
| Description | NCCN guidelines (updated Mar-2019) - RT01 (1 paper) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| URL | https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Guideline Title | NCCN Clinical Practice Guidelines in Oncology -- Prostate Cancer (v1.2019 -- 06-Mar-2019) |
| Description | NCCN guidelines (updated Mar-2019) - STAMPEDE (4 papers) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| URL | https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Guideline Title | Optimizing Anticancer Therapy in Metastatic Non-Castrate Prostate Cancer: American Society of Clinical Oncology Clinical Practice Guideline |
| Description | Prostate ABI SR (PMID: 28800492) ASCO guideline 2018 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | EAU-ESTRO-ESUR-SIOG GUIDELINES ON PROSTATE CANCER |
| Description | Prostate ABI SR (PMID: 28800492) EAU guideline 2018 |
| Geographic Reach | Europe |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | Optimizing Anticancer Therapy in Metastatic Non-Castrate Prostate Cancer: American Society of Clinical Oncology Clinical Practice Guideline |
| Description | Prostate CT SR (PMID: 26718929) ASCO guideline 2018 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | EAU-ESTRO-ESUR-SIOG Guidelines on prostate cancer |
| Description | Prostate CT SR (PMID: 26718929) EAU guideline 2017 |
| Geographic Reach | Europe |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | EAU-ESTRO-ESUR-SIOG GUIDELINES ON PROSTATE CANCER |
| Description | Prostate CT SR (PMID: 26718929) EAU guideline 2018 |
| Geographic Reach | Europe |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der ver-schiedenen Stadien des Prostatakarzinoms |
| Description | Prostate CT SR (PMID: 26718929) GGPO guideline 2017 |
| Geographic Reach | National |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | JUA Evidence-based clinical practice guideline for prostate cancer |
| Description | Prostate CT SR (PMID: 26718929) JUA guideline 2017 |
| Geographic Reach | National |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | NCCN Practice Guidelines in Oncology - v.2.2016 Prostate Cancer |
| Description | Prostate CT SR (PMID: 26718929) NCCN guideline 2016 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | "Meta-analyses of randomized controlled trials also concluded that docetaxel provides a significant OS benefit in this setting, with no evidence that the benefit was dependent on the volume of disease", based on our systematic review and meta-analysis of summary data (PMID: 26718929) |
| Guideline Title | NCCN Practice Guidelines in Oncology - v.4.2018 Prostate Cancer |
| Description | Prostate CT SR (PMID: 26718929) NCCN guideline 2018 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Guideline Title | NHS England: Clinical Commissioning Policy Statement: Docetaxel in combination with androgen deprivation therapy for the treatment of hormone naïve metastatic prostate cancer (Reference: [B15/PS/a]) |
| Description | Prostate CT SR (PMID: 26718929) NHS England guideline 2016 |
| Geographic Reach | National |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | "NHS England has reviewed the evidence and concluded that it is sufficient to enable docetaxel to be routinely funded for the treatment of newly-diagnosed hormone naïve metastatic prostate cancer, where treatment with docetaxel is started within 12 weeks of commencing treatment with ADT.", based on our systematic review and meta-analysis of summary data (PMID: 26718929) |
| Guideline Title | SEOM clinical guidelines for the treatment of metastatic prostate |
| Description | Prostate CT SR (PMID: 26718929) SEOM guideline 2017 |
| Geographic Reach | National |
| Policy Influence Type | Citation in clinical guidelines |
| 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 | STAMPEDE trial protocol version 14 |
| Geographic Reach | Europe |
| Policy Influence Type | Implementation circular/rapid advice/letter to e.g. Ministry of Health |
| Impact | Implemented a clinical trial that rolled out an improvement to the standard-of-care |
| Guideline Title | NCCN Guidelines Version 2.2016 Prostate Cancer |
| Description | US National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology - PR07 (paper 1) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation: EBRT for Patients with High-Risk or Very High-Risk Disease EBRT has demonstrated efficacy in patients at high risk and very high risk. One study randomized 415 patients to EBRT alone or EBRT plus 3-year ADT. 180 In another study (RTOG 8531), 977 patients with T3 disease treated with EBRT were randomized to adjuvant ADT or ADT at relapse. 181 Two other randomized phase III trials evaluated long-term ADT with or without radiation in a population of patients who mostly had T3 disease. 182-184 In all four studies, the combination group showed improved disease-specific and overall survival compared to single- modality treatment. |
| URL | http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Guideline Title | NCCN Guidelines Version 2.2016 Prostate Cancer |
| Description | US National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology - PR07 (paper 2) |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation: EBRT for Patients with High-Risk or Very High-Risk Disease EBRT has demonstrated efficacy in patients at high risk and very high risk. One study randomized 415 patients to EBRT alone or EBRT plus 3-year ADT. 180 In another study (RTOG 8531), 977 patients with T3 disease treated with EBRT were randomized to adjuvant ADT or ADT at relapse. 181 Two other randomized phase III trials evaluated long-term ADT with or without radiation in a population of patients who mostly had T3 disease. 182-184 In all four studies, the combination group showed improved disease-specific and overall survival compared to single- modality treatment. |
| URL | http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Guideline Title | US National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2016 Prostate Cancer |
| Description | US National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology - RT01 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation: EBRT for Patients with High-Risk or Very High-Risk Disease EBRT has demonstrated efficacy in patients at high risk and very high risk. One study randomized 415 patients to EBRT alone or EBRT plus 3-year ADT. 180 In another study (RTOG 8531), 977 patients with T3 disease treated with EBRT were randomized to adjuvant ADT or ADT at relapse. 181 Two other randomized phase III trials evaluated long-term ADT with or without radiation in a population of patients who mostly had T3 disease. 182-184 In all four studies, the combination group showed improved disease-specific and overall survival compared to single-modality treatment. |
| URL | http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Guideline Title | NCCN Guidelines Version 2.2016 Prostate Cancer |
| Description | US National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology - RT01 |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | Quotation: These techniques have permitted safer dose escalation, and resu lts of randomized trials have suggested that dose escalation is associated with improved biochemical outcomes. 163-168 Kuban and colleagues 166 published an analysis of their dose-escalation trial of 301 patients with stage T1b to T3 prostate cancer. Freedom from biochemical or clinical failure was higher in the group randomized to 78 Gy compared to 70 Gy (78% vs. 59%, P = .004) at a median follow-up of 8.7 years. The difference was even greater among patients with diagnostic PSA >10 ng/mL (78% vs. 39%, P = .001). An analysis of the National Cancer Data Base found that dose escalation (75.6-90 Gy) resulted in a dose- dependent improvement in overall survival for men with intermediate- or high-risk prostate cancer. 169 In light of these findings, the conventional 70 Gy dose is no longer considered adequate. A dose of 75.6 to 79.2 Gy in conventional fractions to the prostate (with or without seminal vesicles) is appropriate for patients with low-risk cancers. Intermediate-risk and high-risk patients should receive doses up to 81.0 Gy. 159,170,17 |
| URL | http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf |
| Description | Clinical Trials Advisory and Awards Commitee (Cancer Research UK) -- enza+abi translational project (STAMPEDE) |
| Amount | £188,063 (GBP) |
| Organisation | Cancer Research UK |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 11/2015 |
| End | 10/2021 |
| Description | Clinical Trials Advisory and Awards Commitee (Cancer Research UK) -- metformin comparison -- STAMPEDE |
| Amount | £1,608,605 (GBP) |
| Organisation | Cancer Research UK |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 02/2016 |
| End | 01/2026 |
| Description | MRC research grant - the Re-IMAGINE consortium |
| Amount | £6,347,795 (GBP) |
| Funding ID | MR/R014043/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2018 |
| End | 05/2022 |
| Description | STAMPEDE: abiraterone comparison -- health economics |
| Amount | £24,000 (GBP) |
| Organisation | Cancer Research UK |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 01/2018 |
| End | 07/2018 |
| Description | STAMPEDE: abiraterone comparison -- long-term follow-up |
| Amount | £465,983 (GBP) |
| Organisation | Johnson & Johnson |
| Department | Janssen-Cilag |
| Sector | Private |
| Country | Global |
| Start | 03/2018 |
| End | 03/2021 |
| Description | STAMPEDE "metformin comparison" - Trial Development Group |
| Organisation | Cantonal Hospital St. Gallen |
| Country | Switzerland |
| Sector | Hospitals |
| PI Contribution | Core group developing the "metformin comparison" in STAMPEDE which led to a clinical trial in prostate cancer with funding support from CRUK |
| Collaborator Contribution | Manchester, Warwick, St Gallen - clinical London - statistical, operational, trials |
| Impact | Clinical trial opens in May-2016. Results due in 10 years |
| Start Year | 2015 |
| Description | STAMPEDE "metformin comparison" - Trial Development Group |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Core group developing the "metformin comparison" in STAMPEDE which led to a clinical trial in prostate cancer with funding support from CRUK |
| Collaborator Contribution | Manchester, Warwick, St Gallen - clinical London - statistical, operational, trials |
| Impact | Clinical trial opens in May-2016. Results due in 10 years |
| Start Year | 2015 |
| Description | STAMPEDE "metformin comparison" - Trial Development Group |
| Organisation | The Christie NHS Foundation Trust |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Core group developing the "metformin comparison" in STAMPEDE which led to a clinical trial in prostate cancer with funding support from CRUK |
| Collaborator Contribution | Manchester, Warwick, St Gallen - clinical London - statistical, operational, trials |
| Impact | Clinical trial opens in May-2016. Results due in 10 years |
| Start Year | 2015 |
| Description | STAMPEDE "metformin comparison" - Trial Development Group |
| Organisation | University of Warwick |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Core group developing the "metformin comparison" in STAMPEDE which led to a clinical trial in prostate cancer with funding support from CRUK |
| Collaborator Contribution | Manchester, Warwick, St Gallen - clinical London - statistical, operational, trials |
| Impact | Clinical trial opens in May-2016. Results due in 10 years |
| Start Year | 2015 |
| 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 |
| Description | STAMPEDE FTA elute card study |
| Organisation | Institute of Cancer Research UK |
| Department | Section of Medicine ICR |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We had collected and stored blood samples as part of the STAMPEDE trial using FTA elute cards for simple collection, transport and storage. We entered a partnership with ICR to process the samples. |
| Collaborator Contribution | ICR received and processed the samples. The quality of the samples on the cards was poorer than hoped. ICR used their own grant funding to try many ways to extract the best quality DNA data from the cards. |
| Impact | A report is in progress. A paper will follow. The research fellow doing the majority the work will include this in his PhD thesis. |
| Start Year | 2015 |
| Description | STAMPEDE biobank |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Competitive process to choose sites to host a new Biobank for the STAMPEDE trial. Manchester and Cardiff were the winners. Grant funding has been submitted for. |
| Collaborator Contribution | Will host samples. |
| Impact | None yet |
| Start Year | 2015 |
| Description | STAMPEDE biobank |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Competitive process to choose sites to host a new Biobank for the STAMPEDE trial. Manchester and Cardiff were the winners. Grant funding has been submitted for. |
| Collaborator Contribution | Will host samples. |
| Impact | None yet |
| Start Year | 2015 |
| Description | STAMPEDE docetaxel sample processing |
| Organisation | Clovis Oncology, inc |
| Country | United States |
| Sector | Private |
| PI Contribution | Agreement to process biopsy samples from STAMPEDE trial patients for DNA damage repair deficits |
| Collaborator Contribution | Will receive, process and return samples |
| Impact | None yet |
| Start Year | 2015 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | Dana-Farber Cancer Institute |
| Country | United States |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | Gustave-Roussy Institute |
| Country | France |
| Sector | Academic/University |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | Paoli-Calmettes Institute |
| Country | France |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | Queen Elizabeth Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | Salford Royal Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review and network meta-analysis in advanced prostate cancer |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data; presenting results at conferences and preparing the final manuscript |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write the manuscript |
| Impact | 1 conference presentation, 2 publications ((1) PMID:29233663, (2) DOI:https://doi.org/10.1093/annonc/mdy071) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | Dana-Farber Cancer Institute |
| Country | United States |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | Gustave-Roussy Institute |
| Country | France |
| Sector | Academic/University |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | Janssen Research & Development |
| Country | Global |
| Sector | Private |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | Queen Elizabeth Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | Salford Royal Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STOpCaP - Systematic review of abiraterone in advanced prostate cancer |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This collaboration was established to conduct a systematic review and meta-analysis. Members of the research team were responsible for protocol development; searching for trials; collecting, managing and analysing data and preparing the final manuscript. |
| Collaborator Contribution | Provided advice throughout the project, helped interpret the results and helped write manuscript |
| Impact | 1 protocol and 1 paper (PMID: 28800492) |
| Start Year | 2017 |
| Description | STRATOSPHERE Consortium (previousy S-STAMPEDE working group) |
| Organisation | Almac Group |
| Department | Almac Sciences |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Developing a stratified medicine trial in prostate cancer - work ongoing but agreement that Almac will pay to process samples |
| Collaborator Contribution | Intellectual input into design + Sample processing by Almac |
| Impact | None yet |
| Start Year | 2015 |
| Description | STRATOSPHERE Consortium (previousy S-STAMPEDE working group) |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Developing a stratified medicine trial in prostate cancer - work ongoing but agreement that Almac will pay to process samples |
| Collaborator Contribution | Intellectual input into design + Sample processing by Almac |
| Impact | None yet |
| Start Year | 2015 |
| Description | STRATOSPHERE Consortium (previousy S-STAMPEDE working group) |
| Organisation | King's College Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Developing a stratified medicine trial in prostate cancer - work ongoing but agreement that Almac will pay to process samples |
| Collaborator Contribution | Intellectual input into design + Sample processing by Almac |
| Impact | None yet |
| Start Year | 2015 |
| Description | STRATOSPHERE Consortium (previousy S-STAMPEDE working group) |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Developing a stratified medicine trial in prostate cancer - work ongoing but agreement that Almac will pay to process samples |
| Collaborator Contribution | Intellectual input into design + Sample processing by Almac |
| Impact | None yet |
| Start Year | 2015 |
| Description | STRATOSPHERE Consortium (previousy S-STAMPEDE working group) |
| Organisation | University of Warwick |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Developing a stratified medicine trial in prostate cancer - work ongoing but agreement that Almac will pay to process samples |
| Collaborator Contribution | Intellectual input into design + Sample processing by Almac |
| Impact | None yet |
| Start Year | 2015 |
| Description | hELP trial |
| Organisation | University of Nottingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Participated in the design of the hELP clinical trial which is led by Nottingham now that it is running. Gained funding through NIHR. We applied the MAMS design to design stage. |
| Collaborator Contribution | Leading clinical and operational and design aspects of trial. |
| Impact | DOI 10.1186/s13063-015-1133-z |
| Start Year | 2015 |
| Title | PROMIS MRI methods and description of needed validation for widespread use |
| Description | The MRC PROMIS trial established clearly the potential benefit, and the cost-effectiveness, of an MRI imaging step between identification of patients as possibly needing a prostate biopsy and the trans-rectal biopsy procedure itself. What remains to be done to ascertain whether high quality imaging and consistent radiographic interpretation in high volume can be implemented widely across the NHS. |
| Type | Diagnostic Tool - Imaging |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2016 |
| Development Status | Under active development/distribution |
| Clinical Trial? | Yes |
| Impact | - |
| Description | Briefing paper on docetaxel |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | We developed a briefing paper summarising the results and policy implications from STAMPEDE and STOPCaP. This was distributed via email and on the MRC CTU website to clinicians. |
| Year(s) Of Engagement Activity | 2015 |
| URL | http://www.ctu.mrc.ac.uk/13706/13710/docetaxel_prostate_cancer |
| Description | Briefing paper on upfront zoledronic acid for prostate cancer |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | This briefing paper summarised the evidence on the upfront use of zoledronic acid for men with prostate cancer, based on the results of STAMPEDE and STOPCaP. |
| Year(s) Of Engagement Activity | 2015 |
| URL | http://www.ctu.mrc.ac.uk/13706/13710/zoledronic_acid_prostate_cancer |
| Description | CRUK thank you cards went to all original comparison participants |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Study participants or study members |
| Results and Impact | CRUK thank you cards went to all original comparison participants |
| Year(s) Of Engagement Activity | 2018 |
| Description | Description In this award In personal portfolio A talk or presentation - Various talks to clinical audiences in multiple countries |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Discussion of all results from STAMPEDE and their implications on clinical practice for patients. Invited talks by various STAMPEDE TMG members in various countries. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Discussion of implementing novel clinical trial designs |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Interview with Matt Sydes on Radio 4's World At One to talk about adaptive and novel trial designs. This was organised by MRC Press Office after Jeremy Hunt raised adaptive trials in parliament with reference to Tessa Jowell's comments. This was an opportunity to correct some potential misunderstandings. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Film about the STAMPEDE docetaxel and zoledronic acid results for healthworkers |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | This film explores the STAMPEDE results on whether adding docetaxel or zoledronic acid, or a combination of both, to standard treatment improves overall survival for men with prostate cancer. The film also includes an update on the active arms in STAMPEDE and future plans. It is aimed at healthworkers. |
| Year(s) Of Engagement Activity | 2015 |
| URL | https://vimeo.com/149631719 |
| Description | Film about the STAMPEDE docetaxel and zoledronic acid results for patients |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | This film explores the results of the STAMPEDE trial. STAMPEDE looked at whether adding docetaxel or zoledronic acid, or a combination of both, to standard treatment improves life expectancy for men with prostate cancer. It will be used at a series of Roadshows around the country, as well as being available online. |
| Year(s) Of Engagement Activity | 2015 |
| URL | https://vimeo.com/149626704 |
| 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 | MRC Festival Symposium on Communicating Trial Results |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | The MRC Festival Symposium on Communicating Trial Results aimed to share examples of good practice, challenges and solutions around communicating the results of clinical trials, and to foster future collaboration. The MRC Clinical Trials Unit at UCL hosted the symposium, in partnership with the Association of Medical Research Charities. With presentations, workshops, and lively discussion, attendees discussed the best ways to communicate the results of clinical trials to trial participants, patients, the clinical community and policymakers. There were presentations and sessions with input from the Health Research Authority, Prostate Cancer UK, i-Base, the NCRI Consumer Forum, the MS Society and members of the MRC Clinical Trials Unit at UCL. |
| Year(s) Of Engagement Activity | 2018 |
| URL | https://www.ctu.mrc.ac.uk/news/news-stories/2018/june/mrc-festival-2018-symposium-on-communicating-t... |
| Description | Media coverage of STAMPEDE results |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | The STAMPEDE results were covered in a press briefing in advance of the ASCO conference. They were then picked up by the BBC, Daily Telegraph, Daily Mail and others. |
| Year(s) Of Engagement Activity | 2015 |
| URL | http://www.telegraph.co.uk/news/health/news/11603907/New-hopes-for-prostate-cancer-sufferers.html |
| Description | STAMPEDE Radiotherapy comparison animated abstract |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | An 'animated abstract' summarising the results of the STAMPEDE Radiotherapy comparison. |
| Year(s) Of Engagement Activity | 2018 |
| URL | https://vimeo.com/294574932 |
| Description | STAMPEDE Radiotherapy comparison briefing paper |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | A briefing paper summarising the practice implications of the STAMPEDE Radiotherapy comparison results. |
| Year(s) Of Engagement Activity | 2018 |
| URL | https://www.ctu.mrc.ac.uk/media/1336/stampede-m1rt-briefing-paper-october-2018.pdf |
| Description | STAMPEDE Radiotherapy comparison infographic |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | An infographic summarising the results of the STAMPEDE radiotherapy comparison. |
| Year(s) Of Engagement Activity | 2018 |
| URL | https://www.ctu.mrc.ac.uk/media/1336/stampede-m1rt-briefing-paper-october-2018.pdf |
| Description | STAMPEDE Twitter Q&A - "M1RT comparison" |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Q&A hosted by CTU including a statistician, a senior clinician, a patient representative and a funder |
| Year(s) Of Engagement Activity | 2018 |
| URL | https://twitter.com/MRCCTU/status/1063027833948246017?s=20 |
| Description | Various talks to clinical audiences in multiple countries |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Discussion of all results from STAMPEDE and their implications on clinical practice for patients. Invited talks by various STAMPEDE TMG members in various countries. |
| Year(s) Of Engagement Activity | 2017 |