Novel Randomised Trial in Prostate Cancer awarded St Peters Trust/Royal Free Charity grant
18 July 2014
40,000 men are diagnosed with prostate cancer every year in the UK. There is
much uncertainty about which treatments might be best for these men, so Level I
evidence is often required. Traditionally, Level I evidence comprises a
head-to-head randomised controlled trial (RCT) of a new intervention versus
placebo in which neither the patient nor the doctor knows who is taking what
(‘double-blind’). The treatment allocation is based on chance and the blinding
prevents biases. In surgery, this design is not always ethical or practical.
This means that both doctor and patient have to be made aware of the treatment
received in surgical trials. This causes problems. First, surgeons and patients
often have strong - but sometimes misplaced - ideas of what works, so RCTs are
difficult to recruit to. Second, this often means patients have to seek out
trials, leading to a select group of motivated, commonly more educated and
affluent patients participating in trials. Third, patients who take part in a
trial may not approve of the treatment they have been allocated by chance and
withdraw. These factors have led to the failure of many surgical trials to
accrue. This has been particularly highlighted in localised prostate cancer
RCTs. In fact, 11 RCTs evaluating different interventions in localised prostate
in the last decade have failed to recruit.
Mr Hashim Ahmed, Senior Clinical Lecturer and Honorary Consultant Urological Surgeon, has created a proposal which will explore a new type of trial within the field of surgery, called the cohort-embedded RCT. This design has been used in other non-malignant disease areas and non-surgical interventions. The proposal will be the first to test this design in surgical interventions in prostate cancer. Although prostate cancer has been chosen, an extremely common disease and in which innovative treatments might have a significant patient benefit and impact on the NHS, the lessons we learn in this study will be of relevance to all surgical RCTs. The proposal will test the feasibility and acceptability of the cohort-embedded RCT. As this is the first time that the Urology research group will be using this method of RCTs, it will need to be piloted. In other words, the group will need to show whether men are accepting of the trial and also need to show whether or not the data collected will be as good as a traditional head-to-head trial. A framework in which not just one but many clinical trials could take place at the same time is desired. If successful, it could change the entire way RCTs in surgery are performed. The pilot project will therefore have wide ranging impact on the field of clinical research.