The patients who fall into the active-surveillance category can be identified with reasonable accuracy. The 'gold standard' for clinically insignificant prostate cancer, used by virtually all clinicians who attempt to predict minimal disease according to clinical parameters, is a radical prostatectomy specimen containing less than 0.5 ml of prostate cancer with a Gleason score of 6 or less. Stamey et al. devised this reference standard after examination of prostate glands obtained from 139 consecutively sampled radical cystoprostatectomy specimens, of which 55 (40%) had incidental prostate cancer. The authors concluded that only tumor volumes above the 92nd percentile (0.5–6.1 ml) were clinically significant, according to the assumption that the clinically significant cancer rate and clinical prevalence were both 8%. This approach is arbitrary and concerning.
Many groups have reported the incidence of insignificant disease using this definition. The incidence varies from 30% in patients with stage T1c disease, as reported by Epstein et al.,to values as low as 9–12%.The clinical criteria for predicting minimal disease include a Gleason score of 6 or less, a low PSA density of <0.15,>
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