Clinical trials in prostatic cancer—interpretations and misinterpretations

Abstract

New agents and therapies in prostate cancer, as in other diseases, need to be accurately, comprehensively and logically developed. The golden standard, a prospective, randomised phase III study can only be carried out efficiently if phase I and phase II studies have been completed. The advent of new therapies which will be used in early stage disease, necessitates the development of new methods of measuring their activity and correlating it with an influence on the natural history of the disease. Efforts to get results more quickly by using weaker endpoints and retrospectively carrying out metanalyses have their disadvantages and dangers.

This review will attempt to investigate how clinical trials from phase I through to phase IV in prostate cancer might be improved and made more easily interpretable. It will cover such aspects as the recruitment to trials, the demands of good clinical practice, the use of surrogate endpoints and attempt to give some indications how the newer therapeutic options can be reliably and quickly investigated through clinical trials.