EVALUATION AND FOLLOW-UP OF PATIENTS WITH N1-3 M0 OR NXM1 PROSTATE-CANCER IN PHASE-III TRIALS

Objectives. The aim of this discussion is to review the design and con duct of phase III trials in metastatic prostate cancer, to seek ways o f improving their study design, accuracy, relevance to clinical practi ce, acceptability to patients, and ease of participation by clinicians . We also aim to try to set uniform definitions for the evaluation of the different endpoints used in clinical trials on metastasized prosta te cancer. Methods. The work was started by correspondence between the participants in the group for the year before the consensus meeting. Two comprehensive questionnaires were circulated and the answers were distributed to all the members of the group. The statements were final ized during the consensus meeting. Results. There were some differing opinions concerning the methods of evaluation of endpoints for followu p, such as time to tumor progression and time to treatment failure. Af ter the consensus conference, there were no major disagreements within the group. Conclusions. The aim of phase III trials is to influence c linical management. To obtain a credible result they require a sound s tatistical basis with appropriate power and encompassing patients from small urologic practices as well as large or academic institutions. H owever, deviation from routine practice may affect the accrual rate, a nd the trial procedure should therefore be as similar as possible to r outine management. Trials inevitably involve extra work and cost. Both should be kept to a minimum to encourage participation and hasten a t imely conclusion. It is mandatory to create uniform ways of designing and evaluating clinical trials in prostate cancer. (C) 1997 by Elsevie r Science Inc.