Intended for healthcare professionals


Patients with prostate cancer should be enrolled in a national, controlled trial

BMJ 1999; 318 doi: (Published 09 January 1999) Cite this as: BMJ 1999;318:126
  1. R G Willis, Consultant urologist
  1. Carlisle Hospitals NHS Trust, Cumberland Infirmary, Carlisle CA2 7HY

    EDITOR—I endorse the views of Mulley and Barry on treating prostate cancer.1 British urologists are deluged with data from the United States which encourages radical prostatectomy, yet there is no good evidence from randomised controlled trials to validate their policy.

    If the editorial had been written by an American urologist the conclusion would have been entirely different. Mulley and Barry failed to emphasise the powerful financial motives behind much of what is published about prostate cancer in the United States. There is an undoubted bias in favour of papers that promote screening and radical surgery, including papers that estimate the resulting financial reward per urologist.2 We should note that the American urologist invited by one journal to review “watchful waiting” in early prostate cancer is one of the leading exponents of screening and radical prostatectomy in the United States.3 There is therefore no shortage of biased, uncontrolled, non-randomised data in support of radical surgery.

    The crux of this problem is that radical prostatectomy was “let out of the bag” before being properly evaluated in a randomised controlled trial. What we need is a large study comparing watchful waiting, radiotherapy, and radical prostatectomy.

    We need a system to license new forms of treatment as “approved for clinical trial only.” Any costly new treatment should only be available through a nationally approved and controlled trial. Patients would only have access to the new treatment by agreeing to abide by the protocol, which would include randomisation. Doctors would only be licensed to use the treatment within the trial and only after appropriate training. Trials could recruit much larger numbers of patients and do this more quickly than is currently the case. Those centres involved in the trial could then train others wishing to use the new technique if it is subsequently approved for use across the NHS.

    I do not think that it is too late to consider such a trial for early prostate cancer in the United Kingdom but only if an approach is adopted along the lines suggested—that is, only approved clinical trials for all patients being considered for radiotherapy or radical prostatectomy. How else can we collect the evidence on which to base advice for future generations of men with this enigmatic cancer? How else can we respond to the reasonable plea from Mulley and Barry: “Banish dogma, get more data.”


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