A randomized trial of the choice of treatment in prostate cancer: design and baseline characteristics

Objective To assess the effects of different approaches to decision-making on the treatment chosen for prostate cancer and on the patients' quality of life in prostate cancer, Patients and methods A multicentre randomized trial was conducted. includin g all histologically confirmed cases of prostate cancer diagnosed between S eptember 1993 and November 1994 in four Finnish hospitals. in the intervent ion group, the role of the patient in the choice of treatment was actively emphasized. In the control group. the treatment was chosen using standardiz ed treatment protocols. The first intermediate endpoint was the patient's p articipation in decisionmaking and the next will be the treatment chosen in the intervention and control groups. The main outcome will be the quality of life. Clinical data on prognostic factors including age. tumour grade, s tage, functional Status and serum prostate-specific antigen (PSA) concentra tion was collected for comparison between the arms, and between those enrol led or not. Results In all. 210 of 251 eligible patients were randomized into the two a rms. Patients were randomized before obtaining informed consent. which led to four patients already randomized refusing to participate. The 41 patient s not enrolled were of similar age and grade distribution. but more frequen tly had extensive disease than had those enrolled in the trial. Three patie nts were unable to participate because of rapid deterioration in their gene ral condition after randomization. There were no clear differences in basel ine characteristics (including age, functional status. tumour grade and sta ge) of the patients between the arms. The distribution of PSA level differe d slightly between the arms, which may require adjustment in the analyses. Patients in the intervention arm participated in decision-making more activ ely than those in the control arm. Conclusion Randomized studies on ethical issues such as the patient's role in choosing treatment are feasible and likely to provide important informat ion.