Clinical Utility of Gene Expression Classifiers in Men With Newly Diagnosed Prostate Cancer.

PURPOSE

Tissue-based gene expression classifiers (GECs) may assist with management decisions in patients with newly diagnosed prostate cancer. We sought to assess the current use of GEC tests and determine how the test results are associated with primary disease management.

METHODS

In this observational study, patients diagnosed with localized prostate cancer were tracked through the Michigan Urological Surgery Improvement Collaborative registry. The utilization and results of three GECs (Decipher Prostate Biopsy, Oncotype DX Prostate, and Prolaris) were prospectively collected. Practice patterns, predictors of GEC use, and effect of GEC results on disease management were investigated.

RESULTS

Of 3,966 newly diagnosed patients, 747 (18.8%) underwent GEC testing. The rate of GEC use in individual practices ranged from 0% to 93%, and patients undergoing GEC testing were more likely to have a lower prostate-specific antigen level, lower Gleason score, lower clinical T stage, and fewer positive cores (all < .05). Among patients with clinical favorable risk of cancer, the rate of active surveillance (AS) differed significantly among patients with a GEC result above the threshold (46.2%), those with a GEC result below the threshold (75.9%), and those who did not undergo GEC (57.9%; < .001 for comparison of the three groups). This results in an estimate that, for every nine men with favorable risk of cancer who undergo GEC testing, one additional patient may have their disease initially managed with AS. On multivariable analysis, patients with favorable-risk prostate cancer who were classified as GEC low risk were more likely to be managed on AS than those without testing (odds ratio, 1.84; = .006).

CONCLUSION

There is large variability in practice-level use and GEC tests ordered in patients with newly diagnosed, localized prostate cancer. In patients with clinical favorable risk of cancer, GEC testing significantly increased the use of AS. Additional follow-up will help determine whether incorporation of GEC testing into initial patient care favorably affects clinical outcomes.