Professor Nicholas James BSc MB BS FRCP FRCR PhD

Professor Nicholas James

Institute of Cancer and Genomic Sciences
NIHR Senior Investigator
Professor of Clinical Oncology

Contact details

Address
Consultant Clinical Oncologist
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH

Professor James is Consultant in Clinical Oncology at the Queen Elizabeth Hospital Birmingham and Professor of Clinical Oncology at the University of Birmingham.

Professor James is internationally renowned for his work in Urological Cancer, particularly on the groundbreaking STAMPEDE trial, which has been used to evaluate, to date, 10 different therapies for advanced prostate cancer in more than 10,000 men. He is a regular educational speaker at conferences worldwide, recently including the American Society of Clinical Oncology, European Society of Medical Oncology and European Association of Urologists Annual Meetings. Results from STAMPEDE with both first line docetaxel chemotherapy and abiraterone have shown that big survival gains can be made by using existing treatments in novel settings. These findings have been practice changing worldwide.

In the bladder cancer field he has led a series of trials of chemoradiotherapy culminating in the largest randomised trial in the field, published in the New England Journal of Medicine, with an accompanying editorial describing the study as "landmark" & "practice changing". The trial demonstrated that low dose synchronous chemotherapy reduced invasive bladder cancer relapse rates by 43%.

Outside the clinical and research spheres, Professor James is a closely engaged with patient education initiatives. This is best exemplified by a series of music concerts, in collaboration with the world famous saxophonist Courtney Pine, entitled “It's a Man Thing”. He also co-founded the leading website CancerHelp UK  in 1994. In 2002 it became the main patient resource on the Cancer Research UK website.

Qualifications

  • F.R.C.P. (London) 1998
  • Ph.D. University of London, 1993
  • F.R.C.R. (Clinical Oncology) 1990
  • M.R.C.P. (U.K.) 1986
  • M.B. B.S. University of London 1983
  • B.Sc. (1st Class Honours) "Infection and Immunity".  University of London 1980

Biography

  • Professor James co-founded the leading patient website CancerHelp UK in 1994, now Cancer Research UK’s main patient website. Research into the usage of the site underpinned the Department of Health’s recommendation to incorporate information prescriptions into patient information provision 1.
  • Professor James led the first UK trial of gene therapy in prostate cancer with a virus enzyme pro-drug system developed in our Institute. Following in vitro improvements to our initial virus, we are now trialling a modified version of the initial virus. 2-6
  • He was UK chief investigator on the TAX327 study leading to the licensing of docetaxel for metastatic castrate refractory prostate cancer. 7
  • Chief investigator on the TRAPEZE trial in men receiving chemotherapy for bony metastatic prostate cancer. The trial showed a substantial reduction in serious bone morbidity from the addition of zoledronic acid to standard chemotherapy  8,9.
  •  STAMPEDE Trial Chief Investigator, the largest interventional study in prostate cancer with > 10,000 patients and featuring a novel multi-arm, multi stage design 10-13. Recent results show a 25% improvement in overall survival with the use of docetaxel at diagnosis14,15. The LANCET commented that the trial is “a multinational trial of unparalleled scope and size….” and “Equally important is the drug assessment paradigm.... that enables new .... approaches to be assessed at a more rapid pace than …. with more traditional research designs.”
  • Further STAMPEDE results from 2017 show a 37% improvement in overall survival with use of abiraterone in the same setting. 16,17
  • In the bladder cancer field Professor James has led a series of trials of chemoradiotherapy culminating in the largest randomised trial in the field, published in the New England Journal of Medicine 18,19, with an accompanying editorial 20 describing the study as "landmark""practice changing". The trial demonstrated that low dose synchronous chemotherapy reduced invasive bladder cancer relapse rates by 43%.
  • Longstanding translational collaborations with Rik Bryan 21-31 and Syed Hussain 19,32-38 leading to a range of high impact publications in bladder cancer translational work.
  • As UHB Cancer R&D Director 2008-2013 Professor James re-organised research structures to establish a research operations team. Cancer trial recruitment increased five-fold, from 200 patients entering interventional trials in 2007 to >1200 in 2013 with a consequent increase in trial personnel & resources.
  • Between 2013 & 2016 Professor James moved to the University of Warwick to build new cancer research structures at Warwick, in particular integrating mathematics, computing and chemistry. Designation as a cross-campus Research Centre achieved 2015. 
  • Professor James does substantial community outreach work, talking at 4-5 patient conferences/year. He is currently working with world famous saxophonist Courtney Pine and the Unite Trade Union to increase prostate cancer awareness in Afro-Caribbean men (at 4-fold risk of death from the disease). 
  • Professor James is internationally in demand as a conference speaker – with more than 30 invited international talks in the last 12 months. 

Teaching

Research

My current research is focussed on prostate cancer, principally via the STAMPEDE trial for which I am the Chief Investigator. See www.stampedetrial.org for further details. 

My second focus of research is in bladder cancer and I have two current projects running – the BladderPath trial comparing MRI with surgical staging and the RAD-IO trial comparing chemoradiotherapy alone with with chemoRT + synchronous and adjuvant durvalumab. Both these trial run via the CRCTU in Birmingham.

Other activities

  • Member of Joint Collegiate Council for Oncology working group on consent for treatment in adults 2000
  • Member of NHS Executive Group producing Commissioning Guidance for Urological cancers 2002
  • Chair, Royal College of Radiologists Audit and Standards Committee 2004 to 2006
  • Member of Royal College of Radiologists/Surgeons Committee writing guidelines for the management of prostate cancer 2005
  • British Association of Urological Surgeons Team for guidelines on treatment of metastatic prostate cancer 2006
  • NHS Health Technology Agency Therapeutic Procedures Panel 2007-2010
  • Member of Cancer Reform Strategy Economics Group 2007-8
  • Member of Department of Health Group drafting the Cancer Reform Strategy 2007
  • Co-director Birmingham Research Academy 2008-2011
  • Member of National Cancer Research Institute (NCRI) Bladder Group (Inception to 2015)
  • Member of NCRI Prostate Group (Inception to 2016)
  • R&D Director with responsibility for Cancer Research, University Hospitals Birmingham NHS Trust 2009 -2014.
  • European Urology Association (EAU) Bladder Cancer Guidelines Group 2013-2016
  • Advanced Prostate Cancer Consensus Conference Scientific Panel 2015, 2017 and 2019
  • NIHR Senior Investigator 2017-2020
  • Scientific Committee ESMO Annual Meeting 2017, 2018
  • Cross Whitehall Trial Advice Panel run by the Cabinet Office (the office of the Prime Minister of the UK). The Panel advises on and aims to extend use of trials methodology across all aspects of Government
  • NHS Health Technology Agency Scientific Board 2017 - present

Publications

Parker CC, James ND, Brawley CD, et al: Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet, 2018 

Rydzewska LHM, Burdett S, Vale CL, et al: Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: A systematic review and meta-analysis. Eur J Cancer 84:88-101, 2017 

James ND, de Bono JS, Spears MR, et al: Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med 377:338-351, 2017 

van Osch FHM, Pauwels C, Jochems SHJ, et al: Tar, nicotine and carbon monoxide yield of UK cigarettes and the risk of non-muscle-invasive and muscle-invasive bladder cancer. Eur J Cancer Prev, 2017

 Feber A, Dhami P, Dong L, et al: UroMark-a urinary biomarker assay for the detection of bladder cancer. Clin Epigenetics 9:8, 2017 

Afshar M, Goodfellow H, Jackson-Spence F, et al: Centralisation of radical cystectomies for bladder cancer in England, a decade on from the 'Improving Outcomes Guidance': the case for super centralisation. BJU Int, 2017 

Hussain SA, Palmer DH, Syn WK, et al: Gene expression profiling in bladder cancer identifies potential therapeutic targets. Int J Oncol 50:1147-1159, 2017 

Choudhury A, West CM, Porta N, et al: The predictive and prognostic value of tumour necrosis in muscle invasive bladder cancer patients receiving radiotherapy with or without chemotherapy in the BC2001 trial (CRUK/01/004). Br J Cancer, 2017 

James ND, Pirrie SJ, Pope AM, et al: Clinical Outcomes and Survival Following Treatment of Metastatic Castrate-Refractory Prostate Cancer With Docetaxel Alone or With Strontium-89, Zoledronic Acid, or Both: The TRAPEZE Randomized Clinical Trial. JAMA Oncol, 2016 

James ND, Pirrie S, Pope A, et al: TRAPEZE: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of chemotherapy with zoledronic acid, strontium-89, or both, in men with bony metastatic castration-refractory prostate cancer. Health Technology Assessment 20, 2016 

Vale CL, Burdett S, Rydzewska LH, et al: Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data. Lancet Oncol 17:243-56, 2016 

James ND, Sydes MR, Clarke NW, et al: Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387:1163-77, 2016 

Ward DG, Baxter L, Gordon NS, et al: Multiplex PCR and Next Generation Sequencing for the Non-Invasive Detection of Bladder Cancer. PLoS One 11:e0149756, 2016 

Togneri FS, Ward DG, Foster JM, et al: Genomic complexity of urothelial bladder cancer revealed in urinary cfDNA. Eur J Hum Genet, 2016 

Kitchen MO, Bryan RT, Emes RD, et al: Quantitative genome-wide methylation analysis of high-grade non-muscle invasive bladder cancer. Epigenetics:1-10, 2016 

Bryan RT, Shimwell NJ, Wei W, et al: Urinary EpCAM in urothelial bladder cancer patients: characterisation and evaluation of biomarker potential. Br J Cancer 110:679-85, 2014 

Huddart RA, Hall E, Hussain SA, et al: Randomized noninferiority trial of reduced high-dose volume versus standard volume radiation therapy for muscle-invasive bladder cancer: results of the BC2001 trial (CRUK/01/004). Int J Radiat Oncol Biol Phys 87:261-9, 2013 

Morgan R, Bryan RT, Javed S, et al: Expression of Engrailed-2 (EN2) protein in bladder cancer and its potential utility as a urinary diagnostic biomarker. Eur J Cancer 49:2214-22, 2013 

Bryan RT, Zeegers MP, van Roekel EH, et al: A comparison of patient and tumour characteristics in two UK bladder cancer cohorts separated by 20 years. BJU Int 112:169-75, 2013 

James ND, Hussain SA: A multidisciplinary approach in muscle-invasive disease: novel chemotherapy combinations and targets in chemoradiation. Am Soc Clin Oncol Educ Book:200-6, 2013 

Sydes MR, Parmar MK, Mason MD, et al: Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials 13:168, 2012 

James ND, Hussain SA, Hall E, et al: Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med 366:1477-88, 2012 

Shipley WU, Zietman AL: Old drugs, new purpose--bladder cancer turning a corner. N Engl J Med 366:1540-1, 2012 

Bryan RT, Wei W, Shimwell NJ, et al: Assessment of high-throughput high-resolution MALDI-TOF-MS of urinary peptides for the detection of muscle-invasive bladder cancer. Proteomics Clin Appl 5:493-503, 2011 

Bryan RT, James ND: Bladder cancer: time for a rethink? Oncology (Williston Park) 25:965, 968, 2011 

Patel P, Young JG, Mautner V, et al: A phase I/II clinical trial in localized prostate cancer of an adenovirus expressing nitroreductase with CB1954 [correction of CB1984]. Mol Ther 17:1292-9, 2009 

Sydes MR, Parmar MK, James ND, et al: Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials 10:39, 2009 

James ND, Sydes MR, Clarke NW, et al: Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial. BJU Int 103:464-9, 2009

Young JG, Green NK, Mautner V, et al: Combining gene and immunotherapy for prostate cancer. Prostate Cancer Prostatic Dis 11:187-93, 2008 

Parmar MK, Barthel FM, Sydes M, et al: Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst 100:1204-14, 2008 

James N, Daniels H, Rahman R, et al: A study of information seeking by cancer patients and their carers. Clin Oncol (R Coll Radiol) 19:356-62, 2007 

Hussain SA, Ganesan R, Reynolds G, et al: Hypoxia-regulated carbonic anhydrase IX expression is associated with poor survival in patients with invasive breast cancer. Br J Cancer 96:104-9, 2007 

Hussain SA, James ND: Molecular markers in bladder cancer. Semin Radiat Oncol 15:3-9, 2005 

Searle PF, Chen MJ, Hu L, et al: Nitroreductase: a prodrug-activating enzyme for cancer gene therapy. Clin Exp Pharmacol Physiol 31:811-6, 2004 

Palmer DH, Mautner V, Mirza D, et al: Virus-directed enzyme prodrug therapy: intratumoral administration of a replication-deficient adenovirus encoding nitroreductase to patients with resectable liver cancer. J Clin Oncol 22:1546-52, 2004 

Tannock IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-12, 2004 

Hussain SA, Stocken DD, Riley P, et al: A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer. Br J Cancer 91:844-9, 2004 

Hussain SA, Palmer DH, Ganesan R, et al: Carbonic anhydrase IX, a marker of hypoxia: correlation with clinical outcome in transitional cell carcinoma of the bladder. Oncol Rep 11:1005-10, 2004 

Latham JP, Searle PF, Mautner V, et al: Prostate- specific antigen promoter/enhancer driven gene therapy for prostate cancer: construction and testing of a tissue-specific adenovirus vector. Cancer Res 60:334-41, 2000 

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