Few patients with prostate cancer are willing to be randomised to treatment

Editor—No one would deny the need for controlled prospective trials to determine best management in serious conditions such as prostate cancer. But to adopt a nihilistic approach towards available treatments because such data do not exist is to turn back the clock of progress. Proponents of evidence based medicine may claim that there is no evidence that radical prostatectomy is the treatment of choice for early prostate cancer, but there is no evidence that it is not.

Willis’s suggestion that patients should “only have access to a treatment by agreeing to abide by the protocol, which would include randomisation,” is arrogant, and insulting to patients and doctors.¹ Men with a life expectancy of 10-25 years who develop prostate cancer will not allow themselves to be randomised to a “watchful waiting group” (waiting for what?—disease progression? metastases?), as the early ending of the MRC PRO6 trial showed.

Stepping Hill Urology and the uro-oncologists at the Christie Hospital have for 12 months been conducting a prospective controlled trial to compare radical prostatectomy with radical radiotherapy. Currently 20 patients have been entered and three more are being processed. If funding is forthcoming the study will be opened to the North West region’s urologists and others. All patients are fully counselled by a urologist, a radiation oncologist, and a specialist nurse, then offered randomisation. Of the first 20 patients, only one agreed to be randomised, the other 19 making their own informed decision between the two treatments.

Patients want to make up their own minds regarding their future, and they deserve to have full information about and access to all available treatments. A study comparing surgery and radiotherapy is still possible, but it is unlikely ever to be a randomised study.