Professor James is the Chief Investigator of the STAMPEDE trial which has been recruiting men with advanced prostate cancer to a rolling programme of different clinical questions since 2005. To date more than 11,000 men have been recruited and outcomes assessed on seven different treatment approaches, with three more still under follow up and two new comparisons in the set-up process.
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 earlier disease settings. The New England Journal of Medicine in an editorial accompanying the abiraterone results in 2017 described these as “impressive” and an “important advance for … metastatic prostate cancer”.
Most recently, the third set of major results from STAMPEDE were presented at ESMO 2018 and published in the Lancet. These showed that for men with newly diagnosed metastatic disease of low volume, adding radiotherapy to the prostate to standard drug therapy improved survival times by about 25%.
A large programme of translational work is linked to the STAMPEDE trial, coordinated via Professor Attard’s laboratory at University College London. Additional translational programmes are running in Image analysis and informatics.
In the bladder cancer field, Professor James has led a series of trials of chemoradiotherapy culminating in the largest randomised trial in the field BC2001, published in the New England Journal of Medicine, with an accompanying editorial describing the study as "landmark" and "practice changing".
The trial demonstrated that low dose synchronous chemotherapy with 5FU and mitomycin C reduced invasive bladder cancer relapse rates by 43%. More recent work has assessed the use of cetuximab in this setting and the most recent project (the RAD-IO trial) is examining the use of the immune checkpoint inhibitor durvalumab.
Current bladder cancer projects:
Muscle invasive bladder cancer can be managed with either surgery or radiotherapy. Radiotherapy outcomes can be improved by the addition of systemic radio-sensitisers such as 5FU/Mitomycin C as demonstrated in the BC2001 trial. Despite the reduction in relapses seen, substantial numbers of patients are resistant to therapy or relapse either in the bladder or with metastases.
The recent demonstration that immune checkpoint inhibitors have substantial activity in advanced bladder cancer opens a new therapeutic combination opportunity. The RAD-IO trial is evaluating synchronous chemoradiotherapy as per the BC2001 schedule, with and without prior, synchronous and adjuvant durvalumab.
Bladder cancer treatment and outcomes have not changed significantly in 30 years. Standard initial assessment comprises local anaesthetic inspection of the bladder with a small endoscope. If a bladder tumour is seen, the patient then proceeds to general anaesthetic removal of the tumour via a larger, rigid cystoscope - transurethral resection of bladder tumour (TURBT).
TURBT is a curious procedure as it in an amalgam of a diagnostic test, a staging test (to determine the extent of bladder infiltration) and potentially treatment. Usually these three aspects are separated in cancer care. The BladderPath trial is a randomised phase 2/3 study comparing standard care with an image based pathway.
Patients with suspected muscle invasive bladder cancer will be randomised to either TURBT or to an MRI scan, with further care determined by the imaging findings. The hypothesis is that the image directed pathway will give more accurate rapid assessment of disease extent, accelerating delivery of correct care and improving outcomes.
Outside the clinical and research spheres, Professor James is a closely engaged with patient education initiatives. He co-founded the leading website CancerHelp UK in 1994. In 2002 it became the main patient resource on the Cancer Research UK website.
More recently he has been actively involved in outreach work with men at risk of late diagnosis of prostate cancer. This initially took the form of a series of music concerts, in collaboration with the world-famous saxophonist Courtney Pine, entitled “It's a Man Thing”. More recently the project team has purchased a custom built 'Man Van' and the team are evaluating targeting men’s health screening via places of work, initially via Professor James’s former clinical base at Queen Elizabeth Hospital Birmingham.