Clinical validation of a biopsy-based six-gene signature prognostic for aggressive prostate cancer.

OBJECTIVES

This study aimed to clinically validate the six-gene prognostic molecular clinical risk score (MCRS) for the prediction of aggressive prostate cancer in diagnostic biopsy tissue.

METHODS

MCRS was evaluated in prostate biopsy tissue from a Swedish cohort of men with prostate cancer (UPCA,  = 100). The primary outcome of adverse pathology and secondary outcomes of high primary Gleason (≥G4) and high pathological T-stage (≥T3) were assessed by likelihood ratio statistics and area under the receiver operating characteristic curves from logistic regression models; time to biochemical recurrence was assessed by likelihood ratio statistics and C-indexes from Cox proportional hazard regression models.

RESULTS

Biopsy MCRS was significantly prognostic ( < 0.0001) and added significant prognostic value to clinico-pathological features for adverse pathology, high primary Gleason and high pathological T-stage ( < 0.0001). MCRS was prognostic for biochemical recurrence and added some, albeit non-significant, prognostic value to clinical risk stratifiers, which could reflect the low number of recurrence events in the cohort.

CONCLUSION

Biopsy-based MCRS improves risk stratification over standard clinical and pathological information and optimises patient management after diagnosis of prostate cancer.