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Overtreatment of early-stage low-risk prostate cancer (PC) patientsrepresents a significant problem in disease management and has socio-economicimplications. Development of genetic and molecular markers of clinicallysignificant disease in patients diagnosed with low grade localized PC wouldhave a major impact in disease management. A gene expression signature (GES) isreported for lethal PC in biopsy specimens obtained at the time of diagnosisfrom patients with Gleason 6 and Gleason 7 tumors in a Swedish watchful waitingcohort with up to 30 years follow-up. A 98-genes GES identified 89 and 100percent of all death events 4 years after diagnosis in G7 and G6 patients,respectively; at 6 years follow-up, 83 and 100 percent of all deaths eventswere captured. Remarkably, the 98-genes GES appears to perform successfully inpatients stratification with as little as 2% of cancer cells in a specimen,strongly indicating that it captures a malignant field effect in prostatesharboring cancer cells of different degrees of aggressiveness. In G6 and G7tumors from PC patients of age 65 or younger, GES identified 86 percent of alldeath events during the entire follow-up period. In G6 and G7 tumors from PCpatients of age 70 or younger, GES identified 90 percent of all death events 6years after diagnosis. Classification performance of the reported in this study98-genes GES of lethal PC appeared suitable to meet design and feasibilityrequirements of a prospective 4 to 6 years clinical trial, which is essentialfor regulatory approval of diagnostic and prognostic tests in clinical setting.Prospectively validated GES of lethal PC in biopsy specimens of G6 and G7tumors will help physicians to identify, at the time of diagnosis, patients whoshould be considered for exclusion from active surveillance programs and whowould most likely benefit from immediate curative interventions.

Malignant field signature analysis in biopsy samples at diagnosis  identifies lethal disease in patients with localized Gleason 6 and 7 prostate  cancer