Pathology in prostate research: optimizing the pathological data.

Pathology remains the gold standard for the diagnosis and local staging and grading of prostate cancer. However, as in any discipline, there are variations in national standards and protocols leading to possible significant intra-observer variations. This can significantly impact on the data supplied to clinical trials. Diagnostic and grading criteria. Error rates in the diagnosis of prostate cancer have improved but the possibility that diagnostic error may be discovered has to be addressed in any research series. Major changes in Gleason grading have occurred in the past 40 years and this may lead to suboptimal application of grades in research cohorts, falsely raising the prognostic power of new biomarkers. Tumor measurements and staging criteria. Further information that may provide additional prognostic information include various measures of tumor extent and peri-neural invasion in biopsy specimens. Standardization of measures of tumor extent is necessary to give more useful assessments of prognosis. In radical prostatectomy specimens there are a number of other staging measurements which might be applied, including tumor volume, margin status, extra-capsular extension and nodal positivity though many of these variables are interdependent. Conclusion. Appropriate utilization of such pathological material will produce improved cohorts in which it will be possible to test new biomarkers with increased rigor.